Dissolution and Drug Release Testing. DISSOLUTION SYSTEMS SOURCE BOOK Edition

Transcription

1 Dissolution and Drug Release Testing DISSOLUTION SYSTEMS SOURCE BOOK Edition

2 Welcome Agilent Technologies, Inc. is well known within the pharmaceutical community for its broad portfolio of instruments and supplies, and now offers a variety of dissolution and pharmaceutical testing equipment. Agilent s unique position as a leader in analytical instruments allows us to meet all your needs for equipment, software and reporting packages, qualification documentation and services, training and post-sale support anywhere you operate around the globe. The latest edition of the Dissolution Source Book provides a detailed view of this portfolio, including dissolution apparatus, automated systems, calibration and verification tools, dissolution software, analytical UV-Vis and HPLC integration and physical testing. Here you will find in-depth product descriptions, regulatory information, useful tips, specifications and ordering details for thousands of Agilent dissolution products. Agilent chemists are always available to assist you with dissolution questions. Contact our Dissolution Hotline at dissolution.hotline@agilent.com. More information is available by visiting or by contacting your local Agilent representative.

3 Table of Contents Market Solutions Agilent Solutions for the Pharmaceutical Industry... Industry Information Apparatus, Pharmacopeia and Regulatory Affairs Overview... Dissolution Apparatus and Accessories... Apparatus 1, 2, 5, 6 and Intrinsic 708-DS Dissolution Apparatus... Apparatus 1, 2, 5, 6 and Intrinsic 709-DS Dissolution Apparatus DS and 709-DS Accessories... Dissolution Accessories... Apparatus 3 BIO-DIS Reciprocating Cylinder Apparatus... Apparatus 7 Reciprocating Holder Apparatus 7... Apparatus DS Apparatus 7 for Small-volume Dissolution... Rotating Bottle Apparatus... Dissolution Software... Calibration and Verification Tools... QAII C Mechanical Qualification Station Height/Center Qualification Station... Verification Tools... Automated Dissolution Sampling Systems and Accessories Dissolution Sampling Station Syringe Pump Filter Changer Peristaltic Pump Dissolution Sampling/HPLC Injector... Automated UV Dissolution Systems and Software UV Dissolution Systems... Cary 60 UV Dissolution Systems... Automated HPLC Systems... Physical Testers and Accessories Automated Disintegration Apparatus Hardness Tester Friability Tester Tapped Density Tester... Service and Qualification... Educational Services and Industry Support... Index... Index... Alphabetical Index... Ordering Information

4 Market Solutions Market Solutions Agilent Solutions for the Pharmaceutical Industry About Agilent Agilent Technologies is the world s premier measurement company. Through the company s acquisition of Varian, Inc. in 2010, we expanded our already extensive product portfolio for the pharmaceutical industry. The former VanKel Technology Group, which Varian acquired in 2001, offered many instruments for testing and evaluating pharmaceutical dosage forms including dissolution, disintegration, friability, hardness and tapped density. These products and accessories are now fully integrated in the worldwide Agilent distribution network. Agilent s history spans back to 1939 when Bill Hewlett and Dave Packard started HP and helped shape the technology industry from what is now Silicon Valley in California. Agilent began operating in 1999 as an independent company, but retained the historical HP commitment to innovation and contribution, uncompromising integrity, teamwork, trust and respect for the individual. Practical Solutions for Pharmaceutical Testing With a rich history in supporting the pharmaceutical industry, Agilent offers solutions for drug discovery, development and manufacturing. The addition of the dissolution business furthers Agilent s support of the pharmaceutical industry through a portfolio of leading dissolution instrumentation and services. Being part of a company that provides the leading UV-Vis and HPLC solutions to the pharmaceutical industry allows us to offer complete workflow solutions, from dissolution apparatus, sampling devices, analytical instruments and the software to control them. We manufacture dissolution instrumentation to test nearly every dosage form produced. Our staff of application chemists can assist you in selecting the right apparatus and accessories for your method. Whether in R&D or QA/QC, when it comes to analyzing those samples, we offer industry leading UV-Vis technology through the Cary 60 and Agilent 8453 spectrophotometers. Offline or online systems, we can help you automate your workflow. Should your methodology require HPLC analysis, we have you covered there as well. The Agilent 1200 LC Series, with its flexible, modular design, ensures configurations ideally suited to meet your application requirements. 2

5 Market Solutions Workflow Enhancements We strive to provide solutions for every type of dissolution user, from routine applications to early drug development. Our equipment is designed to be easy to use, flexible and modular in nature. As the workload increases, we offer greater degrees of automation, both in the dissolution test run and sample collection as well as the data analysis and reporting. Purchasing a dissolution system from Agilent ensures you have one vendor to turn to should you have questions or require assistance, so you have less downtime and better utilization of your equipment. Quality At Agilent, we believe that our customers define quality. They do this every day with the products and services they purchase. Customers buy based on perceived value that is, they measure the benefits against the costs and select the product and experience that provides superior value. We, therefore, define quality as customer-perceived value. Agilent products are designed to meet or exceed current published pharmacopeia, as well as FDA and ASTM, requirements at the time of manufacture. Our goal is to supply you with the highest quality pharmaceutical testing solutions on the market. Our products are manufactured in Cary, North Carolina at our ISO 9001:2008-certified facility and our Quality management System provides you the assurance that our company has the requisite quality system in place to support your activities around the globe. More Than Great Products Quality equipment is just one component of your work. We believe education is critical to ensuring correct results. For this reason, we offer numerous educational programs geared to various functions within your company. See page 128 for more information. Agilent Technologies Quality Policy Agilent will earn customer loyalty by providing products, services and interactions of the highest quality and greatest value. To achieve this result, we will: 1. Ensure that all of our products comply with applicable safety and regulatory requirements. 2. Ensure our products meet or exceed their published specifications. 3. Maintain and continually improve the effectiveness of our product and service business management systems to conform at a minimum to ISO 9001 Quality Management Standard or more stringent or legally required standards as dictated by specific markets. 4. Continually monitor and improve customers' total experience. 5. Establish quality requirements for suppliers, partners and contractors and hold them accountable to comply. 6. Treat customers in accordance with Agilent's Standards of Business Conduct and Privacy policies. The Agilent Service Advantage: Helping You Focus On What You Do Best Agilent brings a worldwide network of highly skilled, experienced professionals committed to your success. Our factory-trained field service engineers combine regulatory training along with product maintenance and support knowledge to properly install and qualify your dissolution apparatus. Whether it is Installation or Operational Qualification (IQ/OQ), Performance Verification Testing (PVT, or PQ), or Mechanical Qualification (MQ), we can assist you with initial installations or routine qualification services. We offer customized service agreements based on your specific needs and supported by one of our 65 global service centers. 3

6 Industry Information Industry Information Apparatus, Pharmacopeia and Regulatory Affairs Overview The design of dissolution apparatus is specified by the various pharmacopeias from around the world. In addition, both the FDA and ASTM have called for tighter mechanical specifications. The apparatus is routinely operated in facilities regulated by federal agencies, such as the US Food and Drug Administration, which require laboratories to operate under good manufacturing practices (GMPs). Agilent s dissolution apparatus are developed to operate under GMP environments which require installation, operational, and ongoing performance or mechanical qualifications to verify that the systems are operating as intended. Agilent offers extensive documentation and services that provides full instrument qualifications, including the most recent guidance on mechanical qualification of dissolution apparatus. We provide the instruments and accessories to test essentially all types of dosage forms, including tablets, capsules, semisolids, transdermal patches, microspheres, implants, etc. Our equipment is designed to easily work with immediate, modified, delayed or extended release products. Our designs adhere to the compendial guidelines. We also offer some non-compendial designs when the traditional methodologies are not suitable for some unique drug release characteristics. For more regulatory information from the world's pharmacopeias and international pharmaceutical agencies, visit: 4

7 Industry Information Applications and Testing Capabilities of Agilent Dissolution Apparatus Dissolution Apparatus Common Products Types Stirred Vessel Methods The basket and paddle dissolution apparatus are the most commonly used throughout the world. These methods traditionally require the placement of individual dosage forms into 1L glass vessels containing a fixed volume of fluid referred to as dissolution medium. Agilent 708-DS and 709-DS Dissolution Apparatus for Rotating Basket (USP Apparatus 1) Agilent 708-DS and 709-DS Dissolution Apparatus for Rotating Paddle (USP Apparatus 2) Agilent 708-DS and 709-DS Dissolution Apparatus for Paddle over Disk (USP Apparatus 5) Agilent 708-DS and 709-DS Dissolution Apparatus for Rotating Cylinder (USP Apparatus 6) Shaft with attached mesh basket fabricated from 316 stainless steel; the dosage form is contained within the basket, lowered into media and rotated typically at rpm. Paddle blade fixed to the bottom of a shaft fabricated from 316 stainless steel or Teflon coating; the dosage form is introduced directly to the media and the shaft is rotated typically at rpm. Rotating paddle apparatus (above) with the addition of a transdermal system attached to a stainless steel screen and ring assembly; placed at the bottom of the vessel. Rotating dissolution apparatus that utilizes a rotating cylinder upon which a transdermal patch is placed; cylinder provides mixing by convection principles. Capsules Tablets Floating dosage forms Modified release products Beads Suppositories Tablets Capsules Hydrogels Powders Suspensions Microparticles Transdermal patches Transdermal patches Reciprocating Methods The dosage form is placed within a chamber through which media flows in alternating directions, or on/within numerous holders specifically designed for novel extended release dosage forms. The cylinders or holders typically reciprocate in 300 ml vessels although both larger and smaller outer vessels are available. Agilent BIO-DIS Reciprocating Cylinder Apparatus (USP Apparatus 3) Agilent Reciprocating Holder Apparatus and 400-DS Dissolution Apparatus (USP Apparatus 7) Mimicking the ph changes of the GI tract, glass cylinders containing the dosage form between capped screens of varying mesh sizes reciprocate 10 cm within 300 ml vessels containing media for a designated time period before the dosage form is transported to another row of media (six rows are available). Holders designed for sustained or extended release, including small-volume products, reciprocate through a distance of 2 cm in volumes ranging from 300 ml to 3 ml per sample row or time point. Capsules Beads Enteric coated products Extended, modified or sustained release formulations Transdermal systems Osmotic pumps Implants Drug-eluting stents High-potency, low-dose systems Alternative Applications Additional configurations were developed to provide drug release information for the API and topical formulations. Agilent Intrinsic Apparatus Agilent Enhancer Cell for Diffusion Cells Testing Agilent Peak Vessel Stainless steel die containing a pellet of pure drug substance with a constant surface area to determine the intrinsic dissolution rate; used in early drug development for API characterization. Cells consists of a chamber containing dosage form with synthetic or natural membrane representing skin to test biorelevance using small-volume vessels and miniature paddles. The Peak Vessel contains an inverted peak in the base of the vessel to displace exhibiting the unstirred zone, preventing cone formation. Pure drug substances Ointments Creams Gels Transdermal Beads Products exhibiting coning problems 5

8 Dissolution Apparatus and Accessories Apparatus 1, 2, 5, 6 and Intrinsic 708-DS Dissolution Apparatus Agilent 708-DS Dissolution Apparatus The 708-DS Dissolution Apparatus provides an ideal platform for laboratories to standardize their dissolution testing. This instrument is designed to deliver consistent performance and results while conforming to current internationally harmonized pharmacopeial specifications for basket, paddle, rotating cylinder, paddle over disk and intrinsic dissolution tests. The instrument s versatile dissolution platform is capable of drug performance testing under the most demanding laboratory conditions. The intelligent design accommodates all requirements from basic manual testing to automated configurations for high-throughput sampling and online analysis. The apparatus allows for advanced usage options including automated dosage delivery, in-vessel temperature monitoring, automated sampling and in situ fiber optic analysis. Providing a new standard for reliability and reproducibility in dissolution testing, the rugged platform conforms to either the USP Performance Verification Test (PVT) or the most rigorous enhanced mechanical qualification (MQ) standards as recommended by the ASTM and FDA. The advanced design serves to minimize or eliminate variability, allowing for monitoring subtle changes attributed to dosage forms, not the dissolution apparatus. In fact, particular attention was given to simplifying the measurement of critical parameters, resulting in a smooth and quiet recessed drive unit with unobstructed shaft and vessel access. Hands-free evaporation cover suspension supports easy media addition. Flexible sampling options: access to all vessels and clearance from the vessel plate ensures quick, simple manual sampling through the evaporation cover port. Or, automate your sampling timepoints with the Autosampling feature, the hands-free manifold and the 8000 Dissolution Sampling Station. Accurately measure and record individual vessel temperatures manually with the optional handheld temperature probe or automate this process with AutoTemp In-vessel Temperature Monitoring. Automate your dosage delivery with the Dosage Delivery Module (DDM), or simply introduce samples by manual insertion through the evaporation cover port. Using the DDM feature allows you to precisely drop samples simultaneously or sequentially at a predetermined interval. Customize your instrument with interchangeable dissolution accessory components. The common upper shafts support interchangeable baskets and paddles, yet maintain the correct height to save time when switching configurations. Easily navigate the touch screen panel to setup, store and operate methods on the easy-toread color display. The intuitive interface with screen-locking security features also offers multiple language options for English, Spanish, Japanese and Simplified Chinese. Hands-free evaporation cover suspension offers a simple way to add media to the vessels, manually sample and measure physical parameters. The evaporation covers automatically raise/lower with the apparatus drive unit using either the alignment posts or DDM assemblies. Ensure proper vessel alignment with the 708-DS s TruAlign vessel. The incorporated collar maintains accurate center and verticality alignment and the indicator tab on the collar offers the benefit of reproducible orientation. Decrease cleaning time with the angled water bath that supports complete draining, and saves valuable bench space with the integrated, quiet, vibration-isolating heater/circulator. 6

9 Dissolution Apparatus and Accessories Designed with Compliance in Mind The recessed head with unobstructed access on the 708-DS makes setting and verifying physical parameters easier than ever, which is especially critical for Mechanical Qualification. Agilent has not only raised the standard for dissolution instrumentation with the 708-DS, but has made available a fully enhanced laboratory solution. This includes the traditional AIQ compliance services and documentation consisting of IQ, OQ, PQ and/or MQ. In addition to these traditional offerings, Agilent provides training and familiarization, SOP templates and guidance, educational seminars, technical and application related support, and much more. Physical parameter verification on the 708-DS is simple as illustrated above using the QAII C Mechanical Qualification Station to measure RPM and basket wobble. 21 CFR Part 11 Compliance Agilent's Dissolution Workstation Software provides control of up to four dissolution apparatus from one PC. This software can operate any Agilent dissolution apparatus and sampling systems, as well as systems from Varian and VanKel. See page 62 for more information about the Dissolution Workstation Software. Did You Know? When recording the physical parameters of the dissolution apparatus, during Mechanical Qualification, for example, it is important to measure parameters with the actual shafts and vessels used when performing the dissolution tests. Record the accessory serial numbers and position within the apparatus. Agilent's 708-DS and 709-DS do not require the use of surrogate shafts or vessels to perform these measurements during an OQ, PQ, or MQ. Online Dissolution and Analysis Modular detection and automation components can easily be integrated to accomplish a UV analytical finish during dissolution testing. Agilent offers UV Dissolution capabilities with the industry-leading 8453 UV-visible spectrophotometer, as well as the Cary 60 spectrophotometer with either multicell or fiber optic configurations. See page 84 for more details. Standard 708-DS Configuration Because the 708-DS is designed for configurability, you have the ability to select the exact options you need for your instrument. A standard 708-DS includes: 708-DS Dissolution Apparatus Allen keys for level adjustment and shaft locking collars Receptor shafts with locking collars (6 or 8) Evaporation covers (6 or 8) Basket / paddle height setting devices Vessel centering verification tool Level Heater / circulator QAII C Mechanical Qualification Station adapter ring Technical documentation CD Optional features include: Dosage Delivery Modules (DDM) AutoTemp In-vessel Temperature Monitoring Autosampling with automated manifold Built-in printer Items ordered separately: TruAlign vessels Basket / paddle shafts Baskets Multicell UV Dissolution System, including the 708-DS Dissolution Apparatus, 810 Peristaltic Pump, 8000 Dissolution Sampling Station and Cary 60 UV-visible Spectrophotometer 7

10 Dissolution Apparatus and Accessories 708-DS Dissolution Apparatus Bundles Bundles are available for the most common 708-DS configurations, and include a standard 708-DS with specified features, accessory kits, 1L TruAlign clear vessels and receptor shafts. Paddle shafts, basket shafts and baskets must be ordered separately. In addition to the 708-DS bundles, a custom configuration gives you the flexibility to choose additional options to support your testing needs. 6- or 8-position apparatus and accessory kits DDM option to automate dosage delivery Sampling option via an automated manifold with sample and return cannulas Temperature option via probes for monitoring individual vessel temperatures Online UV dissolution option including a via 200 ml adapter kit, mini paddle and vessel for the standard position for integrating UV dissolution analysis Verified accessories with individual certificates documenting critical dimensions Dosage Delivery Modules (DDM) Note: Vessels, paddles, basket shafts and baskets must be ordered separately with custom configurations. See the example below for accessory ordering information. See page 9 for examples on ordering a custom configuration, or contact your Agilent representative for ordering assistance. Dosage Delivery Modules Equip your 708-DS or 709-DS with DDM to simplify dropping your dosage form when using paddles. Methods can be programmed to automatically start simultaneously or sequentially. The DDM option saves analyst time and prevents costly timing errors. This feature is especially valuable when automated sampling systems are configured. 708-DS Dissolution Apparatus Bundles 708-DS for manual sampling, without manifold, 6-position DS for manual sampling, without manifold, 8-position DS, sampling manifold only, 6-position DS, sampling manifold only, 8-position DS, sampling manifold only, 8-position, for online UV DS, sampling manifold and temperature, 6-position DS, sampling manifold and temperature, 8-position DS, sampling manifold and temperature, 8-position, for UV DS, DDM, sampling manifold and temperature, 6-position DS, DDM, sampling manifold and temperature, 8-position DS, DDM, sampling manifold and temperature, 8-position, for UV

11 Dissolution Apparatus and Accessories To configure a custom 708-DS, select an option from each of the subsections in the Custom Configurations table on the following pages. See the example below for a 6-position, 2L 708-DS with vessels, motorized lift, Autosampling option, AutoTemp option, DDM option, printer, baskets and paddles. Non-resident sampling cannulas in a TruAlign vessel on the 708-DS 708-DS Custom Configuration Ordering Example Quantity DS, 2L, motorized lift, 6-position K DS/709-DS thermal printer assembly K DS/709-DS DDM and upper post, 6-position K DS sampling and temperature kit, 6-position, 2L K DS assembly, common accessories, 1 and 2L, 6-position K Upper receptor shaft, 21 in Paddle, lower interchangeable, electropolished stainless steel, for 2L 6 Basket shaft clip, lower interchangeable, standard USP, for 2L Basket, USP, 40-mesh, 381 µm TruAlign vessel, 2L Temperature Monitoring Verify and monitor individual vessel temperatures prior to starting a test with the AutoTemp option. Once the set temperature is reached, the apparatus can initiate the test without analyst intervention. Adding Automation or UV Dissolution Capabilities The 708-DS Dissolution Apparatus can pair with any Agilent sampling, pumping, filter and UV dissolution instruments to create an automated solution for your laboratory. See page 70 for automated sampling, pumping and filtering options, and see page 84 for automated UV dissolution options. Dosage Delivery Modules (DDM) 9

12 Dissolution Apparatus and Accessories 708-DS Dissolution Apparatus Custom Configurations 708-DS Dissolution Apparatus Base Unit Choose one (1) 708-DS base unit from this section 708-DS, 1L, manual lift, 6-position K DS, 1L, manual lift, 8-position K DS, 1L, motorized lift, 6-position K DS, 1L, motorized lift, 8-position K DS, 2L, manual lift, 6-position K DS, 2L, manual lift, 8-position K DS, 2L, motorized lift, 6-position K DS, 2L, motorized lift, 8-position K DS Dissolution Apparatus Printer Option Choose one (1) printer option for the 708-DS 708-DS/709-DS thermal printer assembly K DS/709-DS assembly, without printer K DS Dissolution Apparatus DDM Option Choose one (1) DDM option for the 708-DS 708-DS/709-DS, manual kit, without DDM and alignment posts, 6-position K DS/709-DS, manual kit, without DDM and alignment posts, 8-position K DS/709-DS alignment post kit, evaporation cover, 6-position K DS/709-DS alignment post kit, evaporation cover, 8-position K DS/709-DS DDM and upper post, 6-position K DS/709-DS DDM and upper post, 8-position K DS/709-DS DDM and upper post kit, 6-position and alignment kit, 2-position K DS/709-DS alignment post kit, 7-position, 200 ml standard, for online UV K DS/709-DS DDM and upper post kit, 6-position, 1 alignment post, 200 ml K standard, for online UV 708-DS Dissolution Apparatus Manifold Option Choose one (1) manifold option for the 708-DS 708-DS without manifold kit K DS temperature kit, 6-position, 1L K DS temperature kit, 8-position, 1L K DS sampling kit, 6-position, 1L K DS sampling kit, 8-position, 1L K DS sampling and temperature kit, 6-position, 1L K DS sampling and temperature kit, 8-position, 1L K DS sampling kit, 1L, 200 ml standard, for online UV K DS sampling and temperature kit, 1L, 200 ml standard, for online UV K (Continued) 10

13 Dissolution Apparatus and Accessories 708-DS Dissolution Apparatus: 8-position, 2L model with motorized lift Hydrodynamic Disturbances Avoid hydrodynamic disturbances caused by resident dwelling probes. The sampling manifold only lowers the probes during sampling lifting the probes between timepoints. 708-DS Dissolution Apparatus Custom Configurations 708-DS Dissolution Apparatus Manifold Option 708-DS fiber optic kit, 6-position, 1L K DS fiber optic and temperature kit, 6-position, 1L K DS temperature kit, 6-position, 2L K DS temperature kit, 8-position, 2L K DS sampling kit, 6-position, 2L K DS sampling kit, 8-position, 2L K DS sampling and temperature kit, 6-position, 2L K DS sampling and temperature kit, 8-position, 2L K DS sampling kit, 2L, 200 ml standard, for online UV K DS sampling and temperature kit, 2L, 200 ml standard, for online UV K DS sampling kit, 6-position, 100 and 200 ml K DS sampling kit, 8-position, 100 and 200 ml K DS temperature kit, 6-position, 100 and 200 ml K DS temperature kit, 8-position, 100 and 200 ml K DS sampling and temperature kit, 6-position, 100 and 200 ml K DS sampling and temperature kit, 8-position, 100 and 200 ml K DS fiber optic kit, 6-position, 100 and 200 ml K DS fiber optic and temperature kit, 6-position, 100 and 200 ml K DS resident sampling kit, 6-position, 900 ml K DS resident sampling kit, 8-position, 900 ml K DS resident sampling kit, 6-position, 500 ml K DS resident sampling kit, 8-position, 500 ml K DS Dissolution Apparatus Temperature Probe Choose probe for manual temperature monitoring (optional). 708-DS vessel temperature probe, handheld K DS Dissolution Apparatus Accessory Kit Option Choose one (1) accessory kit option for the 708-DS 708-DS assembly, common accessories, 1 and 2L, 6-position K DS assembly, common accessories, 1 and 2L, 8-position K DS assembly, common accessories, 1 and 2L, 8-position, UV K DS assembly, common accessories, 1 and 2L, 6-position, amber K DS assembly, common accessories, 1 and 2L, 8-position, amber K DS assembly, common accessories, 1 and 2L, 8-position, UV, amber K DS assembly, common accessories, 100 and 200 ml, 6-position, TruAlign K DS assembly, common accessories, 100 and 200 ml, 8-position, TruAlign K

14 Dissolution Apparatus and Accessories Apparatus 1, 2, 5, 6 and Intrinsic 709-DS Dissolution Apparatus Agilent 709-DS Dissolution Apparatus Using the same platform as the 708-DS, the 709-DS Dissolution Apparatus ensures productivity, reproducibility and ease of use combined with the convenience of a bath-free design. The 709-DS reduces media heating time with Direct Vessel Heating (DVH) capabilities while insulating the vessel from environmental factors and eliminating water bath cleaning. The exclusive design of the chemically resistant, DVH TruAlign vessel incorporates cuttingedge heat-sensing technology in the vessel wall. The unique clear vessel coating offers protection for less breakage, durability and a waterproof barrier for long-lasting performance. The coating also provides complete visibility of the dosage form within the vessel a critical component of the dissolution test. The TruAlign vessel collar is fitted in the ground glass groove to ensure every vessel is perfectly centered and the collar is perpendicular to the vessel walls. The DVH controller resides in the rear of the apparatus and requires no additional bench space. See the 708-DS and 709-DS in Action! View the electronic demo and find out how your laboratory can be more productive! dissolutiondemo Includes a manifold equipped with AutoTemp In-Vessel Temperature Sensing as standard to ensure each vessel temperature is individually measured and recorded prior to and during the dissolution run. Uses 1L DVH vessels and environmental chambers that prevent temperature fluctuations from external air sources such as air conditioning vents. The chambers also provide an added degree of protection in the event a vessel is damaged and the contents are spilled. Reflective bases at the bottom of each chamber enhance visibility of the dosage form. Supports testing of light-sensitive dosage forms with amber environmental chambers and evaporation covers. Bath-free Advantages: How Does it Work? Each dissolution test performed with the 709-DS involves a preheat cycle to equilibrate vessel temperature. During this cycle, the DVH vessels are heated as the temperatures are monitored closely. Since the traditional dissolution basket, or empty shaft, does not provide a great deal of agitation, a custom replacement basket is used during warm up to reduce equilibration time. These attachments are used prior to beginning any basket tests until the set temperature is achieved. The user is then prompted to replace the stirring mechanism attachment with the dosage-filled baskets prescribed by the dissolution method. Under typical test conditions, the preheat cycle is completed in approximately minutes. The combination of DVH technology and the electronic intelligence built into the controller provides vessel temperature stability with unmatched precision. 12

15 Dissolution Apparatus and Accessories Standard 709-DS Configuration Designed for configurability just like the 708-DS, the 709-DS offers the ability to select the exact options you need for your instrument. A standard 709-DS includes: 709-DS Dissolution Apparatus Manifold with AutoTemp Allen keys for level adjustment and shaft locking collars Receptor shafts with locking collars (6 or 8) DVH vessels and environmental chambers (6 or 8) Evaporation covers (6 or 8) Basket / paddle height setting devices Vessel centering verification tool Level Heater / circulator QAII C Mechanical Qualification Station adapter ring Technical documentation CD Optional features include: Custom basket used for preheating inside a DVH vessel Dosage Delivery Modules (DDM) Autosampling cannulas Built-in printer Items ordered separately: Basket / paddle shafts Baskets or paddles 13

16 Dissolution Apparatus and Accessories 709-DS Dissolution Apparatus Bundles Bundles are available for the most common 709-DS configurations, and include: a standard 709-DS with specified features including AutoTemp, accessory kits, 1L TruAlign DVH vessels and receptor shafts. Lower interchangeable basket shafts and paddles, and baskets must be ordered separately. Custom configurations give you the flexibility to choose additional options to support your testing needs. 709-DS with AutoTemp, Autosampling and DDM. 6- or 8-position apparatus and accessory kits DDM option to automate dosage delivery Sampling option via an automated manifold with sample and return cannulas Clear or amber environmental chambers Verified accessories with individual certificates documenting critical dimensions Note: Vessels, paddles, basket shafts and baskets must be ordered separately with custom configurations. See page 17 for accessory ordering information. See below for an example custom configuration or contact your Agilent representative for ordering assistance. 709-DS Dissolution Apparatus Bundles 709-DS system for manual sampling, temperature only, 6-position DS system for manual sampling, temperature only, 8-position DS system, sampling and temperature, 6-position DS system, sampling and temperature, 8-position DS system, DDM, sampling and temperature, 6-position DS system, DDM, sampling and temperature, 8-position To configure a custom 709-DS, select an option from each of the subsections in the Custom Configurations table. See the following example for a 709-DS with 6 positions, motorized lift, Autosampling option, DDM option, amber evaporation covers and environmental chambers, Verified accessories and paddles. 709-DS Custom Configuration Ordering Example Quantity DS, with DVH, motorized lift, 6-position K DS/709-DS thermal printer assembly K DS/709-DS DDM and upper post, 6-position K DS, sampling kit, DVH only, 6-position, 1L K DS DVH accessory kit, verified DVH vessel, amber K environmental chamber DS assembly, common accessories, 1L 6-position, amber K Upper receptor shaft, 21 in., with certificate V 6 Paddle, lower interchangeable, electropolished stainless steel, with certificate V 14

17 Dissolution Apparatus and Accessories 709-DS DVH vessel Adding Automation or UV Dissolution Capabilities The 709-DS Dissolution Apparatus can pair with any Agilent sampling, pumping, filter and UV dissolution instruments to create an automated solution for your laboratory. See page 70 for automated sampling, pumping and filtering options, and see page 84 for automated UV dissolution options. 709-DS Dissolution Apparatus Custom Configurations 709-DS Dissolution Apparatus Base Unit Choose one (1) 709-DS base unit from this section 709-DS, with DVH, motorized lift, 6-position K DS, with DVH, motorized lift, 8-position K DS Dissolution Apparatus Printer Option Choose one (1) printer option for the 709-DS 708-DS/709-DS thermal printer assembly K DS/709-DS assembly, without printer K DS Dissolution Apparatus DDM Option Choose one (1) DDM option for the 709-DS 708-DS/709-DS, manual kit, without DDM and alignment posts, 6-position K DS/709-DS, manual kit, without DDM and alignment posts, 8-position K DS/709-DS alignment post kit, evaporation cover, 6-position K DS/709-DS alignment post kit, evaporation cover, 8-position K DS/709-DS DDM and upper post, 6-position K DS/709-DS DDM and upper post, 8-position K DS/709-DS DDM and upper post kit, 6-position and alignment kit, K position, for UV dissolution 709-DS Dissolution Apparatus Manifold Option Choose one (1) sampling kit for automated sampling (optional) 709-DS, sample tubing, DVH only, 6-position, 1L K DS, sample tubing, DVH only, 8-position, 1L K DS Dissolution Apparatus Vessel Accessory Kit Option Choose the preferred vessel accessory kit for the 709-DS items sold individually, select appropriate quantity 709-DS DVH accessory kit, DVH vessel, clear environmental chamber K DS DVH accessory kit, verified DVH vessel, clear environmental chamber K DS DVH accessory kit, DVH vessel, amber environmental chamber K DS DVH accessory kit, verified DVH vessel, amber environmental chamber K DS Dissolution Apparatus Accessory Kit Option Choose one (1) standard accessory kit for the 709-DS 709-DS assembly, common accessories, 1L, 8-position K DS assembly, common accessories, 1L, 8-position, amber K

18 Dissolution Apparatus and Accessories 708-DS and 709-DS Accessories Baskets, Paddles and Shafts For Apparatus 1 (baskets) and Apparatus 2 (paddles) dissolution testing, Agilent s variety of quality accessories can support your laboratory s needs while maintaining compliance with regulatory standards. Two-piece interchangeable paddle/basket shafts with 40-mesh baskets Two-piece Interchangeable Paddle/Basket Shafts Switching between paddles and baskets is simple with Agilent s two-piece interchangeable paddle/basket shafts. Rather than resetting the height of the individual shafts when you change between paddles and baskets, the upper receptor shaft stays securely in place, while the lower interchangeable paddle or basket shaft can be switched for your specific testing needs. The paddle and basket shaft assemblies are designed with height offsets so that the proper height is maintained after the changeover. These shafts are manufactured to meet or exceed the USP specifications and precisely engineered, minimizing the risk of cross threading and ensuring a secure connection. In addition, the attachment area remains out of the media so there is less chance for contamination and corrosion. Further, each component is serialized for traceability. Did You Know? Agilent provides Verified Dissolution Accessories with individual certificates of conformance (COCs) that document actual measured values of all critical dimensions, the measurement device used for certification and its traceability. A wide variety of Verified Accessories are available, including various paddles, baskets, basket shafts, and vessels to meet your needs for Mechanical Qualification. Verified accessories are denoted with a V at the end of the part number. The 708-DS and 709-DS can also be used with single-piece basket and paddle shafts. The minimum shaft length required is 21 inches. See page 23 for ordering information. For paddle and basket information and ordering details, see page 24. (Left to right) 40-mesh basket, Teflon-coated basket, gold-plated basket, 20-mesh basket, 10-mesh basket, suppository basket, 3-fin basket, mini basket, and bolus basket 16

19 Dissolution Apparatus and Accessories Upper shaft receptor and lower paddle piece 708-DS/709-DS Accessories Paddles, Basket Shafts and Baskets Two-piece Interchangeable Paddle/Basket Shafts Upper Receptor Shafts Upper receptor shaft, 21 in Upper receptor shaft, 21 in., with certificate V Lower Interchangeable Paddle and Basket Shafts Paddle, lower interchangeable, Teflon-coated Paddle, lower interchangeable, Teflon-coated, with certificate V Paddle, lower interchangeable, electropolished stainless steel Paddle, lower interchangeable, electropolished stainless steel, with certificate V Basket shaft, lower interchangeable, 3-clip, USP Basket shaft, lower interchangeable, 3-clip, USP, with certificate V Basket shaft, lower interchangeable, O-ring Basket shaft, lower interchangeable, Zymark type, conical Paddle, lower interchangeable, Teflon-coated, for 2L Paddle, lower interchangeable, Teflon-coated, for 2L, with certificate V Paddle, lower interchangeable, electropolished stainless steel, for 2L Paddle, lower interchangeable, electropolished stainless steel, for 2L, V with certificate Basket shaft 3-clip, lower interchangeable, USP, for 2L Basket shaft 3-clip, lower interchangeable, USP, for 2L, with certificate V Basket shaft, lower interchangeable, O-ring, for 2L Paddle, lower interchangeable, PEEK Mini basket, lower interchangeable, Durafit, stainless steel, O-ring Mini paddle, lower interchangeable, Teflon-coated Mini paddle, lower interchangeable, electropolished stainless steel Baskets Basket, USP, 40-mesh, 381 µm Basket, USP, 40-mesh, 381 µm, with certificate V Basket, mini, 40-mesh, 381 µm Basket, 3-fin assembly, 40-mesh, 381 µm Basket, 3-fin assembly, 20-mesh, 864 µm Basket, 30x30-mesh, 533 µm

20 Dissolution Apparatus and Accessories Vessels for 708-DS and 709-DS Agilent s TruAlign vessels for the 708-DS precisely align the vessel every time. Only TruAlign vessels have a collar incorporated onto the vessel around the ground glass grove, maintaining accurate centering and verticality alignment with the dissolution apparatus. An indicator tab on the collar provides reproducible vessel orientation while the serial number offers easy identification. Using TruAlign vessel design with the fitted collar, the TruAlign DVH Vessels for the 709-DS also incorporate cutting-edge heat-sensing technology in the vessel wall. In addition, the heating element is fused to the glass for accelerated heating. The unique clear vessel coating offers protection for less breakage, ensuring long-lasting, durable performance. The coating allows complete visibility of the dosage form within the vessel a critical component of the dissolution test. 1L TruAlign vessel TruAlign vessels for the 708-DS are available in 100 and 200 ml, 1 and 2L sizes. Amber, Peak, and Verified versions are also available. The TruAlign DVH vessel is available in a 1L size only, and amber environmental chambers and evaporation covers are available for light sensitive products. Conversion Kits The 708-DS Dissolution Apparatus can also be used with a conversion kit for small-volume dissolution. Each position will require a conversion kit to hold the 100 or 200 ml vessel in position, and are designed to be used with either mini paddles or mini baskets, which are sold separately. Special conversion kits, available in sets of 6 and 8, are also available for the Chinese Pharmacopeia (CP) 250 ml vessel. These kits include the 250 ml vessel designed according to CP specifications, vessel adapter ring, two-piece mini paddle, evaporation cover and manifold conversion block. 200 ml Conversion Kit 18

21 Dissolution Apparatus and Accessories (Left to right) 1L TruAlign vessel, 1L amber TruAlign vessel, 2L TruAlign vessel and 200 ml TruAlign vessel 708-DS/709-DS Accessories Vessels and Conversion Kits TruAlign Vessels for 708-DS Dissolution Apparatus TruAlign vessel, 100 ml TruAlign vessel, amber, 100 ml TruAlign vessel, 200 ml TruAlign vessel, amber, 200 ml TruAlign vessel, 250 ml, for Chinese Pharmacopeia TruAlign vessel, 1L TruAlign vessel, 1L, with certificate V TruAlign vessel, amber, 1L TruAlign vessel, amber, 1L, with certificate V TruAlign Peak vessel, 1L TruAlign Peak vessel, amber, 1L TruAlign vessel, 2L TruAlign vessel, 2L, with certificate V TruAlign vessel, amber, 2L TruAlign vessel, amber, 2L, with certificate V TruAlign Peak vessel, 2L TruAlign vessel, flat bottom, 200 ml TruAlign DVH Vessels for 709-DS Dissolution Apparatus TruAlign vessel, DVH, with collar, 1L TruAlign vessel, DVH, with collar, 1L, with certificate V TruAlign Vessel Conversion Kit for 708-DS Dissolution Apparatus TruAlign vessel 100/200 ml conversion kit (includes vessel adapter and evaporation cover) TruAlign vessel, 250 ml conversion kit, for CP (includes vessel, adapter, two-piece mini paddle, evaporation cover and manifold adapter), set of 6 TruAlign vessel, 250 ml conversion kit, for CP (includes vessel, adapter, two-piece mini paddle, evaporation cover and manifold adapter), set of 8 Did You Know? A 708-DS Dissolution Apparatus can easily convert to a small-volume apparatus. For example, to convert a 6-position, 1L 708-DS for 200 ml testing, simply order the parts in the table on the right. Small-volume Conversion Ordering Example Quantity 6 TruAlign vessel, 200 ml TruAlign vessel 100/200 ml conversion kit (includes vessel adapter and evaporation cover)

22 Dissolution Apparatus and Accessories 708-DS and 709-DS Accessories In addition to vessels, paddles, baskets and shafts, Agilent offers a variety of accessories specific to the 708-DS and 709-DS platform. These accessories include replacement tubing assemblies for sampling and return cannulas, sampling and resident probe sampling manifold kits, evaporation covers and more. Adapting to Changing Needs Have your laboratory needs changed? Are you ready to upgrade to an automated sampling system? To add sampling capabilities to your 708-DS or 709-DS choose the Sampling Manifold Kit that best fits your needs based on features and vessel volume. Each kit comes with a sampling manifold, an internal drive assembly, and the features specified in the description. Contact your Agilent representative about scheduling installation of these items: Manual temperature measurement using 708-DS temperature probe 708-DS and 709-DS Accessories Replacement Tubing Assemblies for 708-DS Manifold Includes color-coded sets of tubing Tubing assembly, for 1L 708-DS, sample and return cannulas, 6-position Tubing assembly, for 1L 708-DS, sample and return cannulas, 8-position Tubing assembly, for 2L 708-DS, sample and return cannulas, 6-position Tubing assembly, for 2L 708-DS, sample and return cannulas, 8-position Sampling Manifold Kits for 708-DS and 709-DS Includes manifold, internal drive assembly and other listed features. 708-DS sampling kit, 6-position, 1L K DS sampling kit, 8-position, 1L K DS sampling kit, 6-position, 100 and 200 ml K DS sampling kit, 8-position, 100 and 200 ml K DS sampling kit, 6-position, 2L K DS sampling kit, 8-position, 2L K DS temperature kit, 6-position, 1L K DS temperature kit, 8-position, 1L K DS temperature kit, 6-position, 100 and 200 ml K DS temperature kit, 8-position, 100 and 200 ml K DS temperature kit, 6-position, 2L K DS temperature kit, 8-position, 2L K DS sampling and temperature kit, 6-position, 1L K DS sampling and temperature kit, 8-position, 1L K DS sampling and temperature kit, 6-position, 100 and 200 ml K DS sampling and temperature kit, 8-position, 100 and 200 ml K DS sampling and temperature kit, 6-position, 2L K DS sampling and temperature kit, 8-position, 2L K DS fiber optic kit, 6-position, 1L K DS fiber optic kit, 6-position, 100 and 200 ml K DS fiber optic and temperature kit, 6-position, 1L K DS fiber optic and temperature kit, 6-position, 100 and 200 ml K DS sampling kit, 1L, 200 ml standard, for online UV K DS sampling and temperature kit, 1L, 200 ml standard, for online UV K DS sampling kit, 2L, 200 ml standard, for online UV K DS sampling and temperature kit, 2L, 200 ml standard, for online UV K (Continued) 20

23 Dissolution Apparatus and Accessories Acrylic rinse tray 708-DS and 709-DS Accessories Sampling Manifold Kits for 708-DS and 709-DS Includes manifold, internal drive assembly and other listed features. 709-DS, sample tubing, DVH only, 6-position, 1L K DS, sample tubing, DVH only, 8-position, 1L K Resident Probe Sampling Kits for 708-DS 708-DS resident sampling kit, 6-position, 900 ml K DS resident sampling kit, 8-position, 900 ml K DS resident sampling kit, 6-position, 500 ml K DS resident sampling kit, 8-position, 500 ml K Evaporation Covers and Accessories for 708-DS and 709-DS 708-DS/709-DS evaporation cover, low-loss seal DS/709-DS evaporation cover, standard seal DS/709-DS evaporation cover, low-loss seal, amber DS/709-DS evaporation cover, standard seal, amber DS/709-DS evaporation cover retainer post, for use in place of DDM DS/709-DS evaporation cover plug, white, for use in place of DDM DS/709-DS evaporation cover plug, black, fingertip, for alternative sample opening 708-DS/709-DS evaporation cover plug, black, fingertip, for alternative sample opening, 6/pkg. Miscellaneous Accessories for 708-DS and 709-DS Heater/Circulator, with Wide Input Range Heater, 115/230V Water bath temperature probe DS vessel temperature probe handheld K DDM assembly, for use with 708-DS and 709-DS (sold separately) DS/709-DS thermal printer assembly K Thermal printer paper, for use with 708-DS and 709-DS, 10 rolls/pkg Thermal printer paper, for use with 708-DS and 709-DS, 100 rolls/pkg Cannula rinse cup, with shaft clip Cannula rinse cup carrying tray Acrylic rinse tray, for 708-DS/709-DS Storage rack, two-piece interchangeable basket/paddle shaft Two-piece interchangeable basket/paddle shaft storage rack 21

24 Dissolution Apparatus and Accessories Dissolution Accessories Baskets, Paddles and Shafts For Apparatus 1 (baskets) and Apparatus 2 (paddles) dissolution testing, Agilent s variety of quality accessories can support your laboratory s needs while maintaining compliance with regulatory standards. In keeping with the most current guidance for mechanical qualification, Agilent also offers Verified Dissolution Accessories including baskets, paddles and shafts with certificates of conformity with actual component measurements for all critical dimensions using traceable devices. (Right to left) Electropolished stainless steel paddle, Teflon-coated paddle, PEEK paddle, electropolished mini paddle, and Teflon-coated mini paddle Basket Shafts Whether you need electropolished stainless steel, Teflon-coated, gold-plated or Durafit basket shafts, Agilent provides these individually serialized accessories. Basket shaft options include 3-clip shafts to meet standard USP design, O-ring for automated systems, or conical surface to support air bubble dispersion. A range of basket shaft sizes from 14.5 in. for the discontinued 7025/7030 apparatus to 24 in. for large volume discontinued 7000/7010 instruments are offered. Baskets From the standard USP 40-mesh stainless steel basket, to custom baskets with varying mesh sizes, to baskets specific to small or large dosage forms, Agilent supports your Apparatus 1 needs. Unless otherwise noted, all baskets fit the standard basket shafts. Paddles One-piece paddles are serialized and designed to meet USP specifications for Apparatus 2. Select from electropolished stainless steel, Teflon-coated or the biocompatible, chemically inert PEEK (polyetheretherketone) paddles in a range of sizes. Additionally, mini and mega paddles for small- and large-volume dissolution testing are available. Two-piece Interchangeable Paddle/Basket Shafts Switching between paddles and baskets is simple with Agilent s two-piece interchangeable paddle/basket shafts. Rather than resetting the height of the individual shafts when you change between paddles and baskets, the upper receptor shaft stays securely in place, while the lower interchangeable paddle or basket shaft can be switched for your specific testing needs. The paddle and basket shaft assemblies are designed with height offsets so that the proper height is maintained after the changeover. These shafts are manufactured to meet or exceed the USP specifications and precisely engineered, minimizing the risk of cross threading and ensuring a secure connection. In addition, the attachment area remains out of the media so there is less chance for contamination and corrosion. Further, each component is serialized for traceability. Upper shaft receptor and lower interchangeable paddle piece The 708-DS and 709-DS can also be used with single-piece basket and paddle shafts. The minimum shaft length required is 21 inches. See page 23 for ordering information. 22

25 Dissolution Apparatus and Accessories (Right to left) Standard 3-clip shaft, conical 3-clip shaft, standard O-ring shaft, conical O-ring shaft, Teflon-coated 3-clip shaft, gold-plated 3-clip shaft and mini shaft Close up of standard 3-clip shaft and conical 3-clip shaft Basket Shafts / Assemblies 15 in.(38 cm) Basket Shafts and Assemblies for 7000/7010 (chuck/collet spindle assembly) Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 15 in. shaft Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 15 in. shaft, V with certificate Basket shaft assembly, conical, includes 40-mesh basket, 15 in. shaft Basket shaft assembly, Teflon-coated, includes 40-mesh basket, 15 in. shaft Basket shaft, O-ring, Durafit, 15 in Basket shaft, O-ring, Durafit, conical, 15 in Basket shaft assembly, Durafit, includes 40-mesh mini basket, 15 in. shaft Basket shaft, USP 3-clip, 15 in Basket shaft, USP 3-clip, 15 in., with certificate V Basket shaft, conical, 15 in Basket shaft, mini, Durafit, 15 in Basket shaft, mini, Durafit, for 3/8 in. drive, 15 in Basket shaft, gold-plated lower 6 in., 3-clip, 15 in Basket shaft, Teflon-coated, 3-clip, 15 in Basket shaft, Durafit, Teflon-coated, 15 in Basket shaft, for bolus basket, 15 in in. (37 cm) Basket Shafts for 7025/7030 Basket shaft, USP, Teflon-coated, for 7025/ Basket shaft, USP, Teflon-coated, for 7025/7030, with certificate V Basket shaft, conical, Teflon-coated, for 7025/ Basket shaft, Durafit, Teflon-coated, for 7025/ Basket shaft, Durafit, conical, Teflon-coated, for 7025/ Basket shaft, Durafit, for 7025/ Basket shaft, Durafit, conical, for 7025/ Basket shaft, USP, for 7025/ Basket shaft, USP, for 7025/7030, with certificate V Basket shaft, conical, for 7025/ Basket shaft, mini, Durafit, for 7025/ and 24 in. (48 and 61 cm) Basket Shafts and Assemblies for 705-DS, 7000/7010E (O-ring spindle assembly) Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 19 in. shaft Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 19 in. shaft, V with certificate Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 24 in. shaft Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 24 in. shaft, V with certificate Basket shaft, Durafit, 19 in Basket shaft, Durafit, conical, 19 in Basket shaft, USP 3-clip, 19 in Basket shaft, USP 3-clip, 19 in., with certificate V Basket shaft, conical, 19 in Basket shaft, gold-plated lower 6 in., 19 in (Continued) 23

26 Dissolution Apparatus and Accessories (Left to right) 40-mesh basket, Teflon-coated basket and gold-plated basket Basket Shafts / Assemblies 19 and 24 in. (48 and 61 cm) Basket Shafts and Assemblies for 705-DS, 7000/7010E (O-ring spindle assembly) Basket shaft, 3-clip, Teflon-coated, 19 in Basket shaft, USP 3-clip, 24 in Basket shaft, USP 3-clip, 24 in., with certificate V Basket shaft, for bolus basket, 24 in Baskets Basket, USP, 40-mesh, 381 µm Basket, USP, 40-mesh, 381 µm, with certificate V Mini basket only, 20-mesh, 381 µm Mini basket only, 40-mesh, 381 µm, with certificate V Mini basket only, 20-mesh, 864 µm Mini basket only, 10-mesh, 1905 µm Basket, gold plated, 40-mesh, 381 µm Basket, Teflon-coated, 40-mesh Basket, 3-fin assembly, 40-mesh, 381 µm Basket, 3-fin assembly, 20-mesh, 864 µm Basket, 20-mesh, 864 µm Basket, 20-mesh, 864 µm, with certificate V Basket, 10-mesh, 1905 µm Basket, slotted, for suppository testing Basket, 450x2750-mesh, 1 µm Basket, 400x2800-mesh, 2 µm Basket, 325x2300-mesh, 5 µm Basket, 200x1400-mesh, 10 µm Basket, 165x800-mesh, 20 µm Basket, 325x325-mesh, 43 µm Basket, 270x270-mesh, 53 µm Basket, 150x150-mesh, 104 µm Basket, 100x100-mesh, 140 µm Basket, 50x50-mesh, 280 µm Basket, 30x30-mesh, 533 µm Bolus basket, 20x20-mesh, 864 µm Bolus basket, 40x40-mesh, 381 µm Stationary Baskets and Shafts Stationary basket and shaft, 20-mesh Stationary basket and shaft, 10-mesh Stationary basket and shaft, 1 µm Stationary basket and shaft, 40-mesh Stationary basket and shaft, 100-mesh, 140 µm Stationary basket, Felodipine quadrangular

27 Dissolution Apparatus and Accessories Apparatus and One-piece Paddle Compatibility Paddles 14.5 in. 15 in. 19 in. 24 in * 705-DS 705-DS * 7000** 708-DS 7010** 709-DS 7000** 7010** Apparatus *Chuck/collet spindle assembly **O-ring spindle assembly Electropolished stainless steel paddle Paddle Shafts 15 in. (38 cm) Paddle Shafts for 7000/7010 (chuck/collet spindle assembly) Paddle, Teflon-coated, 15 in Paddle, Teflon-coated, 15 in., with certificate V Paddle, electropolished, stainless steel, 15 in Paddle, electropolished stainless steel, 15 in., with certificate V Paddle, Dura-Tef, 15 in Paddle, PEEK, 15 in Paddle, PEEK, 15 in., with certificate V Paddle, Teflon-coated, 1/4 in. shaft, 200 ml Paddle, Teflon-coated, 3/8 in. shaft tapered to 1/4 in., 200 ml Paddle, electropolished stainless steel, 1/4 in. shaft, 200 ml Paddle, electropolished stainless steel, 3/8 in. shaft tapered to 1/4 in., 200 ml in. (37 cm) Paddle Shafts for 7025/7030 Paddle, Teflon-coated, for 7025/ Paddle, Teflon-coated, for 7025/7030, with certificate V Paddle, electropolished stainless steel, for 7025/ Paddle, electropolished stainless steel, for 7025/7030, with certificate V Paddle, PEEK, for 7025/ Paddle, Teflon-coated, 200 ml, for 7025/ Paddle, Teflon-coated, 200 ml, for 7025/7030, with certificate V Paddle, electropolished stainless steel, 200 ml, for 7025/ and 24 in. (48 and 61 cm) Paddle Shafts for use with 705-DS, 7000/7010E (O-ring spindle assembly) Paddle, Teflon-coated, 19 in Paddle, Teflon-coated, 19 in., with certificate V Paddle, Teflon-coated, 24 in Paddle, Teflon-coated, 24 in., with certificate V Paddle, electropolished stainless steel, 19 in Paddle, electropolished stainless steel, 19 in., with certificate V Paddle, electropolished stainless steel, 24 in Paddle, electropolished stainless steel, 24 in., with certificate V Paddle, PEEK, 19 in Paddle, PEEK, 19 in., with certificate V Paddle, PEEK, 24 in Paddle, PEEK, 24 in., with certificate V Paddle, Teflon-coated, for 3/8 in. drive, 200 ml, 19 in Paddle, Teflon-coated, for 3/8 in. drive, 200 ml, 24 in Paddle, electropolished stainless steel, for 3/8 in. drive, 200 ml, 19 in Paddle, electropolished stainless steel, for 3/8 in. drive, 200 ml, 24 in Mega paddle, 24 in. shaft

28 Dissolution Apparatus and Accessories Paddle support rack Two-piece Interchangeable Paddle/Basket shafts Two-piece Interchangeable Paddle/Basket Shafts Paddle, lower interchangeable, Teflon-coated Paddle, lower interchangeable, Teflon-coated, with certificate V Paddle, lower interchangeable, electropolished stainless steel Paddle, lower interchangeable, electropolished stainless steel, with certificate V Basket shaft, lower interchangeable, 3-clip, USP Basket shaft, lower interchangeable, 3-clip, USP, with certificate V Basket shaft, lower interchangeable, O-ring Basket shaft, lower interchangeable, O-ring, with certificate V Basket shaft, lower interchangeable, Zymark type, conical Upper receptor shaft, 21 in Upper receptor shaft, 21 in., with certificate V Paddle, lower interchangeable, Teflon-coated, for 2L Paddle, lower interchangeable, Teflon-coated, for 2L, with certificate V Paddle, lower interchangeable, electropolished stainless steel, for 2L Paddle, lower interchangeable, electropolished stainless steel, for 2L, V with certificate Basket shaft clip, lower interchangeable, standard USP, for 2L Basket shaft clip, lower interchangeable, standard USP, for 2L, with certificate V Basket shaft, lower interchangeable, O-ring, for 2L Basket shaft, lower interchangeable, O-ring, for 2L, with certificate V Paddle, lower interchangeable, PEEK Mini basket, lower interchangeable, Durafit, stainless steel, O-ring Mini basket, lower interchangeable, Durafit, stainless steel, O-ring, V with certificate Mini paddle, lower interchangeable, Teflon-coated Mini paddle, lower interchangeable, Teflon-coated, with certificate V Mini paddle, lower interchangeable, electropolished stainless steel Mini paddle, lower interchangeable, electropolished stainless steel, V with certificate Shaft Accessories Collet, for 3/8 in. dia. shafts Collet, for 1/4 in. dia. shafts Paddle basket support rack Shaft locking ring, for 705-DS, 708-DS, 709-DS, 7025/ Basket and paddle shaft locking rings, 6/pkg

29 Dissolution Apparatus and Accessories Dissolution Vessels Agilent provides a variety of dissolution vessels for use with Agilent dissolution apparatus, as well as other equipment manufacturers. A wide variety of vessel types, volume sizes, types and collar attachments are available. Agilent's vessels are designed and manufactured to specification, ensuring quality and consistency. EaseAlign Vessels EaseAlign vessels are designed to be used on the discontinued 705-DS, 7000 and 7010 dissolution apparatus, and are compatible with many other manufacturer instruments as well. The EaseAlign vessel is held in place by a centering ring and is available in various types and sizes. TruAlign vessel for the 708-DS Verified Dissolution Accessories Do you need vessels that are certified for conformance with Mechanical Qualification guidelines? Agilent offers Verified Dissolution Accessories with a certificate of conformance that documents the actual measured values of all critical dimensions, the measurement device used for certification, and its traceability. Verified accessories are denoted with a V at the end of the part number. TruCenter Vessels Used with the 7025 and 7030 Dissolution Apparatus, TruCenter vessels offer superior centering and vessel verticality and are turned on a lathe during manufacture to find the exact center. The vessels incorporate a groove and synthetic flange with magnetic collar to align on the vessel plate. The magnetic closure on the vessel plate makes inserting or removing a vessel simple. In addition to not floating when empty, an added benefit of the TruCenter vessel is the plastic collar that decreases the chance of breakage compared to traditional glass collared vessels. Conversion kits are available to upgrade your 705-DS and 7000/7010 models to TruCenter vessels (see page 30). TruAlign Vessels The TruAlign vessels for the 708-DS and 709-DS have a collar incorporated onto the vessel to maintain accurate centering and verticality alignment with the dissolution apparatus. An indicator tab on the collar provides reproducible vessel orientation while the serial number offers easy identification. The TruAlign DVH Vessel for the 709-DS also incorporates cutting-edge heat-sensing technology in the vessel wall. The unique clear vessel coating offers protection for less breakage and complete visibility of the dosage form within the vessel a critical component of the dissolution test. TruAlign vessels for the 708-DS are available in 100 and 200 ml, and 1 and 2 L sizes. Amber, Peak, and Verified versions are also available for select volumes. The TruAlign DVH vessel is available in a 1L size only, and amber environmental chambers and evaporation covers are available for light sensitive products. 27

30 Dissolution Apparatus and Accessories 1L EaseAlign vessel and 1L TruCenter vessel EaseAlign Vessels for 705-DS and 7000/7010 Dissolution Apparatus EaseAlign vessel, 1L EaseAlign vessel, 1L, with certificate V EaseAlign vessel, amber, 1L EaseAlign vessel, amber, 1L, with certificate V EaseAlign vessel, 100 ml EaseAlign vessel, amber, 100 ml EaseAlign vessel, 200 ml EaseAlign vessel, amber, 200 ml EaseAlign vessel, flat bottom for Enhancer Cell, 200 ml EaseAlign vessel, amber, 500 ml EaseAlign vessel, 2L EaseAlign vessel, 2L, with certificate V EaseAlign vessel, amber, 2L EaseAlign vessel, clear plastic, 1L EaseAlign vessel, clear plastic, 1L, with certificate V EaseAlign Peak vessel, 1L EaseAlign Peak vessel, 2L EaseAlign Peak vessel, amber, 1L Did You Know? A leading cause of failure of the USP Performance Verification Test (PVT) is vessel variability. To reduce %CV during this test, it is beneficial to utilize Agilent vessels. To learn more, visit PVTwhitepaper TruCenter Vessels for 7025 and 7030 Dissolution Apparatus TruCenter Vessels for 7025 Dissolution Apparatus TruCenter vessel, without collar, 200 ml TruCenter vessel, with collar, 200 ml TruCenter vessel, with collar, 1L TruCenter vessel, with collar, 1L, with certificate V TruCenter vessel, amber, with collar, 1L TruCenter vessel, amber, with collar, 1L, with certificate V TruCenter Peak vessel, with collar, 1L TruCenter Peak vessel, amber, with collar, 1L TruCenter DVH Vessels for 7030 Dissolution Apparatus TruCenter vessel, DVH, for 7030 only, 1L TruCenter vessel, DVH, for 7030 only, 1L, with certificate V 28

31 Dissolution Apparatus and Accessories 1L TruAlign Peak vessel TruAlign Vessels for 708-DS and 709-DS TruAlign Vessels for 708-DS Dissolution Apparatus TruAlign vessel, 100 ml TruAlign vessel, amber, 100 ml TruAlign vessel, 200 ml TruAlign vessel, amber, 200 ml TruAlign vessel, 250 ml, for Chinese Pharmacopeia TruAlign vessel, 1L TruAlign vessel, 1L, with certificate V TruAlign vessel, amber, 1L TruAlign vessel, amber, 1L, with certificate V TruAlign Peak vessel, 1L TruAlign Peak vessel, amber, 1L TruAlign vessel, 2L TruAlign vessel, 2L, with certificate V TruAlign vessel, amber, 2L TruAlign vessel, amber, 2L, with certificate V TruAlign Peak vessel, 2L TruAlign vessel, flat bottom, 200 ml TruAlign DVH Vessels for 709-DS Dissolution Apparatus TruAlign vessel, DVH, with collar, 1L TruAlign vessel, DVH, with collar, 1L, with certificate V TruAlign Vessel Conversion Kit for 708-DS Dissolution Apparatus TruAlign vessel 100/200 ml conversion kit (includes vessel adapter and evaporation cover) TruAlign vessel, 250 ml conversion kit, for CP (includes vessel, adapter, two-piece mini paddle, evaporation cover and manifold adapter), set of 6 TruAlign vessel, 250 ml conversion kit, for CP (includes vessel, adapter, two-piece mini paddle, evaporation cover and manifold adapter), set of

32 Dissolution Apparatus and Accessories Conversion Kits 200 ml Conversion Kit Small-volume Kits Small-volume conversion kits are an excellent, cost-effective way to use your existing equipment for testing that requires a smaller volume of media. Each position will require a conversion kit to hold the 100 or 200 ml vessel in position. These kits can also be used with Online UV dissolution systems when preparing standards for automated analyses. In this configuration, a single conversion kit is used in position 7 of the dissolution apparatus. The smaller volume allows you to prepare a smaller amount of standard, saving you money. The conversion kits are designed to be used with either mini paddles or mini baskets, which are sold separately. 100 and 200 ml conversion kits are available for the 708-DS, as well as the discontinued 705-DS, 7000/7010, and 7025 Dissolution Apparatus. Note that if you intend to use automated sampling options for these instruments with a small-volume conversion kit, you may need a modified or new sampling manifold to accommodate the change in vessel diameter and sampling position. Large-volume conversion kits in 2L are available for the 7000/7010, as well as the 708-DS Dissolution Apparatus and allow you to work with larger media volumes for your dissolution testing. Small-volume conversion kits, sold individually or in packages, typically include: Vessel(s) Mini paddle(s) Evaporation cover(s) Centering ring assembly(ies) Shaft lengths and diameters, as well as vessel types, are noted with the part number descriptions. Large-volume Kits Large-volume conversion kits include: 2L vessels Apparatus leg extenders Extra-deep water bath Vessel plate system 19 or 24 in. paddles and basket shafts are required for large-volume conversion kits and sold separately. See page 23 for ordering information. TruCenter Conversion TruCenter vessels, standard on the 7025 Dissolution Apparatus, offer superior centering and vessel verticality compared to EaseAlign vessels. Conversion kits are available to upgrade your 705-DS and 7000/7010 models to TruCenter vessels. The TruCenter kit includes: 1L TruCenter vessel Adapter ring Evaporation cover 30

33 Dissolution Apparatus and Accessories 200 ml glass vessel used in conversion kits TruCenter Conversion Kits and Accessories for 705-DS and 7000/7010 Dissolution Apparatus 1L Conversion Kits Conversion kit, TruCenter, with ground groove, 1L Conversion kit, TruCenter, with ground groove, 1L, with certificate V Conversion kit, TruCenter, with manual sampling evaporation cover, 1L ml Conversion Kits Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), for use with chuck assembly spindles, includes collet, 100 ml Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.), for use with O-ring assembly spindles, 100 ml Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.), for use with O-ring assembly spindles, 100 ml, 8/pkg. Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.), for use with chuck assembly spindles, 100 ml Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.), for use with chuck assembly spindles, 100 ml, 8/pkg. Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.), flat bottom vessel, 100 ml Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.), flat bottom vessel, 100 ml, 8/pkg. 200 ml Conversion Kits Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), includes collet, 200 ml Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), includes collet, 200 ml, 6/pkg. Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), includes collet, 200 ml, 8/pkg. Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), flat bottom vessel, includes collet, 200 ml (one per position) Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), flat bottom vessel, includes collet, 200 ml, 6/pkg. 2L Conversion Kits Conversion kit, 6-vessel, 3x3, 2L, for 7000/7010 only Conversion kit, 8-vessel, 4x4, 2L, for 7000/7010 only Conversion Kits Accessories Height spacer, for paddle and 100 and 200 ml round bottom vessels, 15 mm, for /7010 only Height spacer, for 100 and 200 ml, 3.25 in., for 7000/7010 only Evaporation cover, EaseAlign, for use with 100/200 ml vessel

34 Dissolution Apparatus and Accessories Conversion Kits and Accessories for 7025 Dissolution Apparatus 100 ml Conversion Kit Conversion kit, TruCenter, with 15 in. paddle (3/8 in. dia. tapered to 1/4 in.), 100 ml 200 ml Conversion Kits Conversion kit, TruCenter, with 14.5 in. paddle (3/8 in. dia. tapered to 1/4 in.), 200 ml Conversion kit, TruCenter, with 14.5 in. paddle (3/8 in. dia. tapered to 1/4 in.), for use with AutoTemp, 200 ml Conversion Kits Accessories TruCenter vessel, with collar, 200 ml TruCenter vessel, without collar, 200 ml DS conversion kit, 200 ml vessel with mini paddle Conversion Kits for 708-DS Dissolution Apparatus TruAlign vessel 100/200 ml conversion kit (includes vessel adapter and evaporation cover) TruAlign vessel, 250 ml conversion kit, for CP (includes vessel, adapter, two-piece mini paddle, evaporation cover and manifold adapter), set of 6 TruAlign vessel, 250 ml conversion kit, for CP (includes vessel, adapter, two-piece mini paddle, evaporation cover and manifold adapter), set of

35 Dissolution Apparatus and Accessories Capsule Wire, Weights and Sinker Baskets Capsule wire, weights and sinker baskets are used to retain a solid dosage form at the bottom of the vessel for testing when the dosage form is buoyant. Depending on your dosage form a variety of options are available. The flexible capsule wire has a in. diameter and is made of made of stainless steel. The USP compendial wire is twisted around the dosage form in order to provide sufficient mass to ensure the dosage form sinks to the bottom of the vessel. Sinker baskets are offered in a variety of mesh sizes and made of stainless steel. The press-on caps use O-rings to seal the basket closed once the dosage form is inserted. The Japanese Pharmacopoeia (JP) sinker basket is also available as an alternative. A three-prong capsule weight can be used to retain your capsule for testing. These weights fit traditional capsule sizes one through three, and are sold individually. Capsule weight wire (top row), two versions of wire sinkers and a Japanese sinker (second row), mesh sinkers (third row) and 3-prong sinkers (fourth row) When to Use a Sinker Sinkers are used during a dissolution test to sink a dosage form that would otherwise float. The USP specifies that a small piece of non-reactive material, such as not more than a few turns of steel wire, can be attached to the dosage form to prevent floating. Other validated sinkers may also be used for this purpose. Capsule Wire, Weights and Sinker Baskets Capsule Wire and Weights Capsule weight wire, 316 stainless steel, dia., 50 ft Capsule weight, 3-prong Capsule weight, robotic type, with magnetic cap Capsule weight, robotic type, with magnetic inserts in legs Sinker Baskets Sinker basket, with cover, 10-mesh, 1905 µm Sinker basket, with cover, 8-mesh, 2591 µm Sinker basket, with cover, 20-mesh, 864 µm Sinker basket, with cover, 40-mesh, 381 µm Sinker basket, with cover, 100-mesh, 140 µm Sinker basket, with cover, 60-mesh, 229 µm Sinker basket, with cover, 150-mesh, 104 µm Sinker basket, with cover, 270-mesh, 53 µm Sinker basket, with cover, 325-mesh, 45 µm Did You Know? Weights and sinker baskets may also be used for sticky dosage forms, as well as powders contained in capsule shells. Sinker Baskets Dimensions Inside diameter Outside diameter (with cover) Inside height Outside height (without cover) Outside height (with cover) 20.3 mm / 0.8 in. 25 mm / 0.98 in mm / 0.46 in. 15 mm / 0.59 in. 20 mm / 0.79 in. 33

36 Dissolution Apparatus and Accessories Manual sampling on the 708-DS Sampling and Temperature Measurement For a quick, manual sampling solution, Agilent s Cannula Luer Lock assembly is comprised of a bent cannula and a sampling syringe that are best used with the Full Flow Filters. The sampling cannulas are available two in different lengths based on the volume of media, 500 or 900 ml, from which you will sample. Resident sampling kits for use when there is no automated manifold are available to pull samples through a resident-dwelling probe. Please note that probes left in the media during a dissolution run will alter the hydrodynamics and affect the rate of release. Therefore, it is critical that resident probe methods are validated against manual sampling to ensure the integrity of the dissolution test is intact. Resident probes are available for the discontinued 705-DS, as well as the 708-DS and non-agilent apparatus. For automated sampling with Agilent s discontinued (i.e., Varian or VanKel) 7000/7010 Dissolution Apparatus, the automated manifold can be programmed to lower and raise sampling cannulas at specific timepoints when used with the 8000 Dissolution Sampling Station. The manifold supports sampling in media volumes between 750 ml and 1L. The standard sampling manifolds withdraw samples from the 900 ml USP sampling point, halfway between the top of the paddle/basket and the top of the media. For sampling at lower volumes down to 500 ml, stainless steel cannula extensions may be added to the sampling cannula using a Teflon adapter. Full Flow Filters are recommended for sampling. The discontinued 7025 and 7030 Dissolution Apparatus include individual sampling cannulas that may include temperature probes as well. The sampling depth of the cannulas is preset and stored in the firmware of the instrument based on the apparatus installed and volume. The cannulas are only submerged at the time of sampling to minimize hydrodynamic disturbance. The 708-DS and 709-DS also support an automated, non-resident manifold, which is included in those systems preconfigured for automated sampling. Any unit without the automated manifold can be retrofitted by our service organization. As with the 7025 and 7030 apparatus, the depth of the manifold is preset and stored in the firmware of the instrument based on the apparatus installed and volume. Contact your Agilent representative for details. Autosampling manifolds can also support the AutoTemp In-Vessel Temperature Sensing System to lower temperature probes at a specifically programmed time. Once the temperature is measured, the manifold removes the probes to avoid hydrodynamic disturbances. AutoTemp makes starting methods easy, particularly when combined with the Dosage Delivery Module (DDM) option. As soon as the desired temperature is reached, the values are recorded and the dosage forms are introduced. Like the Autosampling option, AutoTemp is available on new apparatus and may also be retrofitted to an existing instrument. 34

37 Dissolution Apparatus and Accessories For Your Sampling Needs Agilent offers a variety of height spacers to increase working space when performing manual sampling. See page 68 for Verification Tools, including these spacers. Full Flow Filters are recommended for use with automated sampling options. See page 39 for details. Manual Sampling Accessories Bent cannula with Luer Lock, for sampling from 900 ml in 1L vessels, 4.75 in Bent cannula with Luer Lock, for sampling from 500 ml in 1L vessels, 7.75 in Bent cannula, with adjustable gauge for setting height, 4.75 in Bent cannula, with adjustable gauge for setting height, 7.75 in Adjustable gauge kit, for 4.75 in. cannulas (cannulas not included) Adjustable gauge kit, for 7.75 in. cannulas (cannulas not included) Cannula, PEEK, for low-volume sampling Filter holder, 25 mm Glass syringe, 20 cc Syringe, with 4.75 in. cannula assembly Syringe, with 7.75 in. cannula assembly Luer Lock fitting bracket, for manual sampling, for 7000/ (requires sampling manifold) (Left to right) Glass syringe, 4.75 in. bent cannula, 7.75 in. bent cannula with adjustable gauge kit and Full Flow Filters 35

38 Dissolution Apparatus and Accessories Resident cannula kit on the 708-DS Resident Sampling Kits/Accessories for the 7000/7010 Dissolution Apparatus Resident cannula and bushing, for sampling at 4.5 in Resident cannula kit, for stainless steel centering rings, 6/pkg Resident cannula kit, for EaseAlign centering rings, for use with paddles, 6/pkg Resident cannula kit, for EaseAlign centering rings, for use with baskets, 6/pkg Resident cannula kit, for EaseAlign centering rings, 1/pkg Resident cannula and bushing, for sampling at 2.5 in Evaporation cover, with UV-Vis adapter, for use with EaseAlign centering rings Resident Sampling Kits/Accessories for the 705-DS, 708-DS and TruCenter Conversion Kits 708-DS resident sampling kit, 6-position, 900 ml K DS resident sampling kit, 8-position, 900 ml K DS resident sampling kit, 6-position, 500 ml K DS resident sampling kit, 8-position, 500 ml K Sample cannula assembly, 500 ml for 705/708-DS Sample cannula assembly, 900 ml for 705/708-DS Sampling Cannulas and Accessories Sampling cannula, 4.5 in. (for 7000/7010 manifold) Sampling cannula, 6.5 in., for 500 ml in 1L vessel (for 7000/7010 manifold) Cannula extension kit, 500 ml (for use with one 4.5 in. cannula) Sampling cannula, 8.12 in., for 2L vessel (for 7000/7010 manifold) Sampling cannula, 10 in., for 4L vessel (for 7000/7010 manifold) Adapter, manual sampling cannula, for PNs and Manual sampling cannula assembly, 500 ml Manual sampling cannula assembly, 900 ml Sampling cannula, for 7025/ Return cannula, for 7025/ Manual sampling cannula, for sampling through apparatus head on 7025/ Return cannula, 2 1/4 in

39 Dissolution Apparatus and Accessories Non-resident sampling inside a 709-DS DVH vessel. Manifolds for Automated Sampling and Temperature Measurement for the 7000/7010 Dissolution Apparatus Sampling Manifold with Internal Motor Drive Sampling manifold, with motorized drive, for 3x3 configuration Sampling manifold, with motorized drive, for 4x2 configuration Sampling manifold, with motorized drive, for 4x4 configuration Sampling manifold, for use with 200 ml and mini paddles, with motorized drive, for 3x3 configuration Internal Motor Drive (manifold not included) Internal motor drive, for 3x3 configuration Internal motor drive, for 4x2, 4x3, 4x4 configurations Sampling Manifold (internal motor drive not included) Sampling manifold, for use with 3x3 configuration, 1L Sampling manifold, for use with 4x2 configuration, 1L Sampling manifold, for use with 4x4 configuration, 1L Sampling/temperature manifold, for use with 3x3 configuration, 200 ml Sampling/temperature manifold, for use with 4x4 configuration, 200 ml Sampling/temperature manifold, for use with 4x2 configuration, 200 ml Sampling manifold, for use with 3x3 configuration, 200 ml Sampling manifold, for use with 4x4 configuration, 200 ml Sampling manifold, for use with 4x2 configuration, 200 ml Sampling manifold, for use with UV Dissolution System and 4x3 or 4x configurations Sampling/temperature manifold, for use with 4x3 or 4x4 configurations Sampling manifold, for use with 4x4 configuration, 100 ml Sampling manifold, for use with 4x2 configuration, 100 ml Sampling/temperature manifold, for use with 4x4 configuration, 100 ml Sampling/temperature manifold, for use with 4x2 configuration, 100 ml AutoTemp Manifold with Internal Motor Drive (temperature probes only) AutoTemp manifold, with motorized drive, for 3x3 configuration AutoTemp manifold, with motorized drive, for 4x2 configuration AutoTemp manifold, with motorized drive, for 4x3 configuration AutoTemp manifold, with motorized drive, for 4x4 configuration AutoTemp Manifold (internal motor drive not included) AutoTemp manifold, for 3x3 configuration AutoTemp manifold, for 4x2 configuration AutoTemp manifold, for 4x3 configuration AutoTemp manifold, for 4x4 configuration Note: Motorized drives should be installed by your Agilent representative. 37

40 Dissolution Apparatus and Accessories Filtration Dissolution continues until a sample is filtered, so it is critical to filter at the specified timepoint. When using manual or automated sampling cannulas, you have the option to use one of Agilent s Full Flow Filters or conventional filter tips to ensure the integrity of your dissolution sample. Full Flow Filters Made of either ultrahigh molecular weight polyethylene (UHMWPE) or the polyvinylidene fluoride (PVDF), the Full Flow Filter offers increased surface area to optimize filter life and prevent clogging. In those instances where chemical compatibility is an issue with UHMWPE, we offer PVDF filters. These are made of a low protein-binding material that can filter a wide variety of active drug substances. Both UHMWPE and PVDF filters can be used with 1/8 in. diameter cannulas and are available in packs of 100 or Conventional Filter Tips Standard conventional filter tips are made of polyethylene fluoride and can also be used with 1/8 in. diameter cannulas. The Agilent 808 Filter Changer works with the 25 mm ROBY automation filters. Automation Filters Agilent also offers automation filters for use with the filter changer when finer filtration is required for multiple sample timepoints with a syringe pump. The 25 mm Whatman/Schleicher & Schuell MicroScience ROBY automation filters are individually lot analyzed and designed to work with the Agilent 808 Filter Changer, as well as other automation ready filter changers. The housing for these filters is designed to avoid membrane compression and ensure the integrity of the filter. Available in a wide variety of membranes, these filters are housed in prestacked tubes of 25 filters for easy loading. Roby25 Automation Filters Selection Table (for use with 808 Filter Changer) Category Product Name and Filter Material Recommended Application I Roby25 1 µm GF 92 filter, glass fiber The standard filter for difficult-to-filter samples to retain course particles. I Roby µm GF 55 filter, glass fiber The best filter for gelatinous capsule dosage forms. II Roby µm CA-GF filter, cellulose acetate glass fiber Extremely low protein binding, better than PVDF filters. II Roby µm NL filter, nylon Robust membrane allows for applications where protein binding is not critical = 1000/pkg = 200/pkg = 1000/pkg = 200/pkg = 1000/pkg = 200/pkg = 1000/pkg = 200/pkg. III Roby µm NL filter, nylon glass fiber Most appropriate when membrane filters get clogged and a glass fiber filter alone is not a suitable substitute. III Roby µm RC-GF filter, regenerated cellulose glass Most appropriate when membrane filters get clogged and a glass fiber filter alone is not a suitable substitute. III Roby µm RC filter, regenerated cellulose Most appropriate when membrane filters get clogged and a glass fiber filter alone is not a suitable substitute. Filter Classification: Category I = glass fiber filter, Category II = membrane filter, Category III = membrane plus glass fiber prefilter = 1000/pkg = 200/pkg = 1000/pkg = 200/pkg = 1000/pkg = 200/pkg. 38

41 Dissolution Apparatus and Accessories Filter Validation Kit Determining the correct filter is simple with this kit, which contains seven different types of filters including 25 of each different membrane type. Filter selection validation guidance is also included. Filter validation sample kit Order in Bulk Save money by ordering our economical 1000 pack! Same high quality filters, just packaged in bulk. Filters and Filter Tips for Sampling Cannulas Original Full Flow Filters Full Flow Filter, UHMWPE, blue, 10 µm, 100/pkg Full Flow Filter, UHMWPE, blue, 10 µm, 50/pkg Full Flow Filter, UHMWPE, blue, 10 µm, 1000/pkg Full Flow Filter, UHMWPE, white, 35 µm, 100/pkg Full Flow Filter, UHMWPE, white, 35 µm, 50/pkg Full Flow Filter, UHMWPE, white, 35 µm, 1000/pkg Full Flow Filter, UHMWPE, red, 70 µm, 100/pkg Full Flow Filter, UHMWPE, red, 70 µm, 50/pkg Full Flow Filter, UHMWPE, red, 70 µm, 1000/pkg Full Flow Filter, PVDF, green, 10 µm, 100/pkg Full Flow Filter, PVDF, green, 10 µm, 1000/pkg Full Flow Filter, PVDF, yellow, 35 µm, 100/pkg Full Flow Filter, PVDF, yellow, 35 µm, 1000/pkg Filter Tips Filter tip, PE, 2 µm, 100/pkg Filter tip, PE, 5 µm, 100/pkg Filter tip, PE, 10 µm, 100/pkg Filter tip, PE, 20 µm, 100/pkg Filter tip, PE, 45 µm, 100/pkg Note: PE = polyethylene, PVDF = polyvinylidene fluoride, UHMWPE = ultrahigh molecular weight polyethylene Full Flow Filters 39

42 Dissolution Apparatus and Accessories Centering Rings and Evaporation Covers Some legacy Varian and VanKel dissolution apparatus use centering rings to ensure vessels are perfectly centered every time and to ensure empty vessels do not float when the water bath is filled. Depending on your apparatus, TruAlign, TruCenter or EaseAlign centering rings and vessels can be used. Evaporation covers maintain volumetric accuracy of the media used during dissolution testing by slowing the amount of media lost to evaporation. Like the centering rings, a variety of evaporation covers are available to fit your apparatus and vessels. Evaporation plugs are used to minimize evaporation by sealing unused ports in the evaporation covers. Centering Rings and Accessories Centering ring, EaseAlign, for 705-DS and 7000/ Centering ring, EaseAlign, retrofit, 6-position, includes pins and evaporation covers Centering ring, EaseAlign, retrofit, 8-position, includes pins and evaporation covers Locating pins, EaseAlign, 12/pkg Conversion kit, EaseAlign, for Hanson vessels, 6/pkg Alignment plate, TruCenter EaseAlign centering ring and Evaporation Covers 40

43 Dissolution Apparatus and Accessories Amber and clear evaporation covers for the 708-DS and 709-DS. Evaporation Covers and Accessories Evaporation cover, low-loss split hinge design Evaporation cover, low-loss hinged, for EaseAlign centering rings Evaporation cover, low-loss hinged, for use with resident probes Evaporation cover, amber, with DDM opening, for EaseAlign centering rings Evaporation cover, for use with 4L vessels Evaporation cover, standard, for stainless steel centering rings Evaporation cover, robotic Zymark type, for stainless steel centering rings Evaporation cover, EaseAlign Evaporation cover, EaseAlign, PVC Evaporation cover, EaseAlign, for basket Evaporation cover, for basket and stainless steel centering rings Evaporation cover, EaseAlign, for DDM Evaporation cover, EaseAlign, for use with 100/200 ml vessel Evaporation cover, EaseAlign, amber Evaporation cover, for stainless steel rings, 4L Evaporation cover, for use with EaseAlign, solid cover for non-vessel positions Evaporation cover, manual sampling, opening for Japanese sinkers, for 7025/7030 Evaporation cover, dual sampling, for 7025/ Evaporation cover, manual sampling for baskets, opening for Japanese sinkers, for 7025/7030 Evaporation cover, manual sampling for baskets, with DDM, for 7025/ Evaporation cover, for three openings for basket and two sampling ports Evaporation cover, for single opening for basket and auto start Evaporation plugs, 36/pkg Evaporation hole plug, for 7025/ DS/709-DS evaporation cover, low-loss seal DS/709-DS evaporation cover, standard seal DS/709-DS evaporation cover, low-loss seal, amber DS/709-DS evaporation cover, standard seal, amber DS/709-DS evaporation cover retainer post, for use in place of DDM DS/709-DS evaporation cover plug, white, for use in place of DDM DS/709-DS evaporation cover plug, black, fingertip, for alternative sample opening 708-DS/709-DS evaporation cover plug, black, fingertip, for alternative sample opening, 6/pkg. 41

44 Dissolution Apparatus and Accessories Did You Know? Agilent's 708-DS can also support transdermal testing using USP Apparatus 5 and 6 accessories. This includes setup and storage of precise sampling manifold locations in the firmware based on vessel volume and the assembly installed. The 708-DS is easily converted to smaller volumes typically associated with transdermal testing as well. See page 18 for more information about 708-DS volume conversion kits. Transdermal Delivery Systems USP Apparatus 5, 6, and 7 Apparatus 5, or Paddle Over Disk, and Apparatus 6, Rotating Cylinder, are commonly used for the testing of transdermal patches per USP General Chapter <724>. USP Apparatus 5 Paddle Over Disk The Paddle Over Disk assembly is used for the dissolution testing of transdermal patches, and is used with a standard dissolution apparatus and paddles. The assembly is made of a 316 stainless steel disk and Teflon locking ring that holds the removable, replaceable screens in place. Screens are provided with the ring assemblies but are also offered in a variety of other sizes which are sold separately. Agilent also offers a transdermal patch holder system as an alternative to the traditional Apparatus 5 assembly. Also made of 316 stainless steel, the O-ring assembly eliminates the need for adhesives to hold the patch. The clam-shell design secures the patch in place and exposes only the active release area of patches with an inactive perimeter around the release area. Custom holders are also available by simply contacting your Agilent representative. USP Apparatus 6 Rotating Cylinder The Rotating Cylinder assembly uses a 316 stainless steel cylinder and includes four slots at the top for improved media circulation over the transdermal patch. The two-piece design includes a removable extension for testing larger transdermal patches. USP Apparatus 7 Reciprocating Holder Transdermal delivery systems may also be tested with Apparatus 7 using a variety of sample holders. For more information on the instrumentation and holders available from Agilent, see page 56. Teflon Suspension Cups For suspensions, the Teflon suspension cup is a weighted holder with a hemispheric bottom designed to sit at the bottom of a standard 1L vessel to control the exposed surface area. The suspension is weighed in the center cup prior to analysis in order to correlate the release rate. Teflon Suspension Cup 42

45 Dissolution Apparatus and Accessories Transdermal Delivery Systems Paddle Over Disk Paddle Over Disk assembly, with 35 mm opening, 40-mesh screen Paddle Over Disk assembly, with 35 mm opening, 40-mesh screen, V with certificate Paddle Over Disk assembly, 125 µm, EP Replacement screens, 125 µm, EP, 100/pkg Replacement screens, 35 mm openings, 40-mesh, 100/pkg Disk disassembly kit, for PN Paddle Over Disk assembly, with 56 mm opening, 120-mesh screen Replacement screens, 56 mm openings, 120-mesh, 100/pkg Disk disassembly kit, for PN Transdermal Patch Holders Transdermal patch holder, 2.5 cm Transdermal patch holder, 5.0 cm Transdermal patch holder, 7.0 cm Transdermal patch holder, 10.0 cm Watch glass screen, polypropylene, 6/pkg Watch glass screen, stainless steel, 6/pkg Suspension Cups Weighted holder, 5.72 cm outside dia., 0.52 cm inside dia Insert cup, 17.5x8.2 mm, use with PN Insert cup, 20x8.2 mm, use with PN (Left to right) Paddle Over Disk assemblies, transdermal patch holders and suspension cup. Rotating Cylinder and Accessories Rotating Cylinder, 4.45 cm outside dia Rotating Cylinder, 4.45 cm outside dia., with certificate V Rotating Cylinder, 25 mm outside dia Rotating Cylinder, 4.45 cm outside dia., for 7025 only Rotating Cylinder, 25 mm outside dia., for 7025 only Lower interchangeable shaft for Rotating Cylinder Lower interchangeable shaft for Rotating Cylinder, with certificate V Rotating Cylinder, 25 mm outside dia., with interchangeable shaft Cuprophan membrane, 126x345 mm, 10 sheets/pkg Height gauge, Rotating Cylinder, USP

46 Dissolution Apparatus and Accessories Did You Know? The Enhancer Cell is now included in the new USP General Chapter <1724> Semisolid Drug Products - Performance Tests to appear in USP35 - NF20, 2nd supplement, Enhancer Cell Designed for release rate dissolution testing of ointments, creams, gels and topicals Used in research, quality control and product development laboratories, the Enhancer Cell provides release rate data for topicals using your standard Apparatus 1 or 2 with either a standard 1L paddle method or 200 ml vessel with mini paddle. Also known as the Vertical Diffusion Cell and External Receptor Chamber Type, the Enhancer Cell is a Teflon cell with adjustable volume and retaining cap to eliminate air pockets trapped against the skin or artificial membrane that provide the diffusion barrier. It is a cost-effective alternative to investing in the fragile and more labor-intensive Franz Cells. Ideal for testing ointments, creams and gels Available in several surface areas, including 0.5, 2.0 and 4.0 cm 2 Used with traditional dissolution apparatus and a 200 ml flat bottom vessel or 1L vessel Meets SUPAC guidelines An alignment tool, available in various sizes to match membrane surface area size, is used to hold the membrane in place while eliminating air pockets with the universal adjustment tool. Alignment tools specific to the surface area are sold individually. A full Enhancer Cell kit, with Enhancer Cell membrane, adjustment and alignment tools, is available in the 4.0 cm 2 surface area size. The Enhancer Cell conforms to the proposed USP Pharmacopeial Forum Chapter <1724> Performance Tests for Topical Drug Products. Enhancer Cell and accessories 44

47 Dissolution Apparatus and Accessories Enhancer Cells and Accessories Enhancer Cell, 4 cm 2 surface area membrane (one per position) Enhancer Cell, 2 cm 2 surface area membrane (one per position) Enhancer Cell, 0.5 cm 2 surface area membrane (one per position) Enhancer Cell kit, 4 cm 2 surface area membrane, adjustment and alignment tools Alignment tool, for 4 cm 2 Enhancer Cell (only one required) Alignment tool, for 2 cm 2 Enhancer Cell (only one required) Alignment tool, for 0.5 cm 2 Enhancer Cell (only one required) Adjustment tool, for all Enhancer Cell sizes (only one required) Cuprophan membrane, 126x345 mm, 10 sheets/pkg Enhancer Cell Ordering Examples In addition to your apparatus, the following ordering examples describe the items that should be ordered for Enhancer Cell use. Enhancer Cell Ordering Example 1: 708-DS conversion, 6 positions, 4 cm 2 Enhancer Cell Quantity 6 Enhancer Cell, 4 cm 2 surface area membrane (one per position) Alignment tool, for 4 cm 2 Enhancer Cell (only one required) Adjustment tool, for all Enhancer Cell sizes (only one required) Mini paddle, lower interchangeable, electropolished stainless steel (one per position) 6 TruAlign vessel, flat bottom, 200 ml (one per position) TruAlign vessel 100/200 ml conversion kit, includes vessel adapter and evaporation cover, (one per position) Enhancer Cell Ordering Example 2: 7010, 8 positions, 0.5 cm 2 Enhancer Cell, with 15 in. shafts and a sampling/temperature manifold Quantity 8 Enhancer Cell, 0.5 cm 2 surface area membrane (one per position) Alignment tool, for 0.5 cm 2 Enhancer Cell (only one required) Adjustment tool, for all Enhancer Cell sizes (only one required) Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), flat bottom vessel, includes collet, 200 ml (one per position) 1 Sampling/temperature manifold, for use with 4x4 configuration, 200 ml

48 Dissolution Apparatus and Accessories Intrinsic Dissolution Apparatus The Intrinsic Dissolution Apparatus provides the dissolution rate of a pure active pharmaceutical ingredient (API) by exposing the API to a constant surface area of dissolution medium. The intrinsic rate is determined by rotating the apparatus in a dissolution vessel containing 37 C media and pulling samples until at least 10% of the API has dissolved. The rate is then calculated by plotting the cumulative amount of API dissolved from the exposed surface area with respect to time. Based on the modified Woods Apparatus as described in USP <1087>, the design includes threaded rings on the inside of the die cavity to prevent the compacted API from falling out of the die cavity during analysis. The apparatus includes a punch used to compress the API into a pellet with the aid of a laboratory press (not provided by Agilent). The Intrinsic Apparatus includes: Stainless steel die cavity with 0.5 or cm 2 surface area Punch Shaft with holder Gasket ring The surface plate, used in conjunction with the punch and a laboratory press, is sold separately and only one plate is required. Intrinsic dissolution is expressed in terms of mg/time/cm 2, and is useful in studying the solubility characteristics of a pure drug substance. Intrinsic Dissolution Apparatus and accessories 46

49 Dissolution Apparatus and Accessories Intrinsic Dissolution Apparatus Intrinsic Dissolution Apparatus, 0.5 cm 2 exposed surface area, with punch, shaft and holder, for 7000/7010* Intrinsic Dissolution Apparatus, 0.5 cm 2 exposed surface area, with punch, shaft and holder, for 7000E/7010, 708-DS, 705-DS* Intrinsic Dissolution Apparatus, 0.5 cm 2 exposed surface area, for use with 7025* Intrinsic Dissolution Apparatus, cm 2 exposed surface area* Intrinsic Dissolution Apparatus, cm 2 exposed surface area, for 7025* Intrinsic die, 0.5 cm 2 exposed surface area Punch Shaft and die holder only, for intrinsic dissolution Surface plate, for intrinsic dissolution *Surface plate sold separately. Only one plate required for testing. Note: The Intrinsic Dissolution Apparatus is not recommended for use with DVH models, including the 7030 and the 709-DS. Intrinsic Dissolution Apparatus Examples In addition to the standard dissolution apparatus, to configure the base unit for intrinsic dissolution use, see the following examples: Intrinsic Dissolution Ordering Example 1: 708-DS, 6 positions Quantity 6 Intrinsic Dissolution Apparatus, 0.5 cm 2 exposed surface area, with punch, shaft and holder, for 7000E, 708-DS, 705-DS 1 Surface plate, for Intrinsic Dissolution Intrinsic Dissolution Ordering Example 2: 7010, 8 positions, with 15 in. shafts Quantity 8 Intrinsic Dissolution Apparatus, 0.5 cm 2 exposed surface area, with punch, shaft and holder, for 7000/ Surface plate, for Intrinsic Dissolution

50 Dissolution Apparatus and Accessories Water Baths and Heater/Circulators Agilent offers a number of water baths and replacement parts for the water baths, including fittings, adapters, tubing and clamps, as well as heater/circulators. Acrylic fabricated water baths for disintegration testers, the Rotating Bottle and BIO-DIS apparatus are made of a three-piece construction with solvent-welded seams. The molded high-performance polymer PETG design, utilized on most Agilent dissolution apparatus, provides better chemical and heat stability than standard acrylic baths and the rounded corners make cleaning easier. The 750 External Heater/Circulator is a bench-top, all purpose heater/circulator that monitors water bath temperature directly using an internal thermistor. Additional replacement heater/circulators for use with current or previous models as well as OEM dissolution apparatus are offered in both 115 and 230 voltages. The 750 External Heater/Circulator is compatible with 7000/7010, BIO-DIS, Apparatus 7 and can also be used with non-varian dissolution apparatus. The 7025 and 705-DS dissolution apparatus require different heater/circulators specially designed for each model series. Please refer to the chart to select the appropriate heater/circulator, as well as the correct voltage. The 708-DS utilizes a universal voltage heater/circulator. It is designed specifically to fit beneath the apparatus housing and minimize vibration. 750 Heater/Circulator 48

51 Dissolution Apparatus and Accessories Molded Water Bath Did You Know? Several vessel plate configurations were available with the 7000/7010 Dissolution Apparatus. To help distinguish: 3x3 indicates 2 rows of 3 vessels 4x2 indicates 2 rows of 4 vessels with 6 active spindle locations (back 2 middle positions empty) 4x4 indicates 2 rows of 4 vessels with 8 active spindle locations Water Baths, Heaters/Circulators and Accessories Water Baths and Replacement Parts Water bath, molded, conversion kit for 3x3 configuration Water bath, molded, conversion kit for 4x4 configuration Water bath, molded, conversion kit for 12-spindle 19 in. paddles/baskets Water bath, molded, conversion kit for 16-spindle 24 in. paddles/baskets Water bath, molded, for use with 3x3 configuration Water bath, molded, for use with 4x4 configuration Water bath, 19x12x8 in Water bath, 12x12x8 in Water bath, 24x12x8 in Water bath, for 7025 and Water bath, for 100 Automated Disintegration Tester, with fittings Water bath, for Rotating Bottle, 24x12x12 in Water bath, 38x12x8 in Water bath, 42x12x8 in Water bath, for BIO-DIS, 22.56x20.68x7.5 in Water bath, for 2 and 4L or Rotating Bottle, 19x12.7x15.3 in Water bath, for 2L, 8-spindle, 24.5x12.7x15.3 in Drain valve for molded bath Bulkhead bath fitting Bath flow deflector Barbed angle adapter PVC tubing with 3/4 in. outer dia., 1/2 in. inner dia., 50 ft Bath tubing clamps, stainless steel, 4/pkg Heater/Circulators 750D heater/circulator, 115V D heater/circulator, 230V Heater/circulator, for 7025, 115V Heater/circulator, for 7025, 230V Heater/circulator, universal, 115V Heater/circulator, universal, 230V Heater/circulator, with Wide Input Range Heater, for 708-DS, 115/230V Acrylic Water Bath 49

52 Dissolution Apparatus and Accessories Apparatus 3 BIO-DIS Reciprocating Cylinder Apparatus and Accessories BIO-DIS Reciprocating Cylinder Apparatus Did You Know? The BIO-DIS Reciprocating Cylinder Apparatus requires a periodic Performance Qualification (PQ) using chlorphenirame maleate extendedrelease tablets, according to the USP PVT for Apparatus 3. To arrange this service, contact your Agilent representative: Extended release-rate dissolution testing that meets requirements of USP Apparatus 3 and EP Reciprocating Cylinder specifications The Agilent BIO-DIS Reciprocating Cylinder Apparatus is ideal for automatic dissolution testing of dosage forms that require different types of media. Typically used for imitating the ph changes that occur in the body, this instrument is perfectly suited for extended and sustained release dosage forms. The BIO-DIS can automatically perform a complete media change, simulating the shift from stomach conditions to the intestine. Due to the reciprocating action and the change in ph, the instrument may be used for a variety of applications. Capable of running unattended for extended periods of time, the BIO-DIS can store up to 15 programs and provide direct control over timepoints, agitation rate, sampling rate, movement between vessel rows, hold dip time, and drain time. The BIO-DIS is designed to meet current USP and EP specifications. The instrument automatically traverses up to six rows of corresponding outer media tubes filled with different media. Custom instruments with additional rows are available as well. Features include: Simulate gastrointestinal conditions with simple programming that allows in vitro dissolution ph profiling with biorelevant agitation rates and retention times. Useful for release-rate testing of floating dosage forms, beads and chewables. Use one instrument to test and transport a variety of samples, saving valuable bench space. Samples are automatically transported from one medium to the next without operator intervention. Be confident knowing the BIO-DIS is compliant with the reciprocating cylinder apparatus, USP Apparatus 3 and EP harmonized specifications. Select a standard volumetric reciprocating cylinder option or small and large volume configuration to meet testing needs for low dose or poorly soluble formulations. Other options include a double row instrument for increased testing throughput (the number of media changes is reduced in half with this option). The standard seven-tube system includes the following items: 3 outer media tube vessel carriers, 14 positions each 7 inner sample tubes with upper and lower caps 1 sample kit of polypropylene and stainless steel screens 42 outer media tubes, 300 ml (USP) 1 external heater/circulator 50

53 Dissolution Apparatus and Accessories Automated Sampling for BIO-DIS Easily automate the sample collection process for Apparatus 3 using the Agilent 8000 Dissolution Sampling Station. See page 73 for more details. Filtration Options Accomplish manual inline filtration using 5 µm disc filters with Luer Lock fittings. See page 38 for more details. Or use the 808 Filter Changer and 806 Syringe Pump to automate filtration with 25 mm automation-ready filters that sample down to 0.45 µm pore size. See page 78 for more details. BIO-DIS Reciprocating Cylinder Apparatus BIO-DIS, 115V, 60 Hz BIO-DIS, 230V, 50 Hz Conversion and Retrofit Kits Conversion kit, 100 ml Conversion kit, 1L Conversion kit, double row dip, 300 ml Conversion kit, double row dip, 1L Conversion kit, double row dip, 1L / 300 ml Retrofit kit, double row dip, 300 ml* Retrofit kit, double row dip, 1L* Retrofit kit, double row dip, 1L / 300 ml* *Retrofit kits must be installed by an Agilent representative Did You Know? The Dissolution Workstation Software can be used to control up to four (4) systems with the BIO-DIS, a pump, and the 8000 Dissolution Sampling Station. In fact, the software allows for multiple samples per row and additional media changes beyond the traditional capability of the instrument. BIO-DIS accessories 51

54 Dissolution Apparatus and Accessories Did You Know? Apparatus 3 may also be used for disintegrating dosage forms by using which creates improved mixing for particulates that may pass through the lower screen. BIO-DIS Reciprocating Cylinder Accessories Inner Sample Tubes (with threaded glass ends) Standard inner sample glass tube for 300 ml outer media tube Inner sample glass tube for 100 ml outer media tube Outer Media Tubes Outer media tube, USP, 300 ml Outer media tube, 100 ml Outer media tube, 100 ml, with 100 ml calibration line Outer media tube, 100 ml, with 50 ml calibration line Outer media tube, flat bottom, 1000 ml Outer media tube, 300 ml, graduated Upper and Lower Caps Standard upper cap, USP, 300 ml, for use with P/N Upper cap, 100 ml, for use with P/N Standard lower cap, USP, 300 ml, for use with P/N Lower cap, 100 ml, for use with P/N Lower cap, wider diameter for improved mixing, for use with P/N Sample and Return Cannulas Sample and return cannula, 5.5 in Return cannula, 2.75 in Evaporation Caps Evaporation cap, USP, for 300 ml tube Evaporation cap, for 100 ml tube Evaporation cap, USP, tinted, for 300 ml tube Vessel Carrier for Outer Media Tubes Vessel carrier, for 300 ml tube, 7x2 layout, set of Vessel carrier, for 100 ml tube, 7x2 layout, set of Vessel carrier, for 1000 ml tube, 1x3 layout, set of (Continued) 52

55 Dissolution Apparatus and Accessories BIO-DIS Reciprocating Cylinder Accessories Replacement Screens for Inner Sample Tubes Polypropylene screens, 1.25 in. dia. for 300 ml tubes, 20-mesh, 840 µm Polypropylene screens, 1.25 in. dia. for 300 ml tubes, 40-mesh, 405 µm Polypropylene screens, 1.25 in. dia. for 300 ml tubes, 56-mesh, 250 µm Polypropylene screens, 1.25 in. dia. for 300 ml tubes, 78-mesh, 177 µm Polypropylene screens, 1.25 in. dia. for 300 ml tubes, 100-mesh, 150 µm Polypropylene screens, 0.75 in. dia. for 100 ml tubes, 20-mesh, 840 µm Polypropylene screens, 0.75 in. dia. for 100 ml tubes, 40-mesh, 405 µm Polypropylene screens, 0.75 in. dia. for 100 ml tubes, 78-mesh, 177 µm Polypropylene screens, 0.75 in. dia. for 100 ml tubes, 100-mesh, 150 µm Stainless steel screens, 1.25 in. dia. for 300 ml tubes, 10-mesh, 1905 µm Stainless steel screens, 1.25 in. dia. for 300 ml tubes, 20-mesh, 864 µm Stainless steel screens, 1.25 in. dia. for 300 ml tubes, 30-mesh, 533 µm Stainless steel screens, 1.25 in. dia. for 300 ml tubes, 40-mesh, 381 µm Stainless steel screens, 1.25 in. dia. for 300 ml tubes, 100-mesh, 140 µm Stainless steel screens, 1.25 in. dia. for 300 ml tubes, 200-mesh, 74 µm Stainless steel screens, 1.25 in. dia. for 300 ml tubes, 300-mesh, 46 µm Stainless steel screens, 1.25 in. dia. for 300 ml tubes, 400-mesh, 38 µm Stainless steel screens, 0.75 in. dia. for 100 ml tubes, 8-mesh, 2591 µm Stainless steel screens, 0.75 in. dia. for 100 ml tubes, 10-mesh, 1905 µm Stainless steel screens, 0.75 in. dia. for 100 ml tubes, 20-mesh, 864 µm Stainless steel screens, 0.75 in. dia. for 100 ml tubes, 40-mesh, 381 µm Stainless steel screens, 0.75 in. dia. for 100 ml tubes, 60-mesh, 229 µm Basket Adapters Basket adapter, Durafit Basket adapter with clip assembly BIO-DIS screens BIO-DIS Dimensions Height Width Depth Weight cm / 29 in cm / 27 in cm/ 27.5 in kg / 95 lbs, dry without vessels 53

56 Dissolution Apparatus and Accessories Apparatus 7 Reciprocating Holder Apparatus 7 Dosage Holder Options Agilent offers a variety of standard and customizable holder options to meet your application needs. These include reciprocating disks, angled disks, and cylinders for transdermal patches. For traditional oral dosage forms, acrylic pointed rods, stent holders and mini baskets are available. Integration Options for Sampling and Filtration Both the seven- and twelve-row systems can be integrated with the 8000 Dissolution Sampling Station, 808 Filter Changer and 806 Syringe Pump to automate filtration with 25 mm automation-ready filters that sample down to 0.45 µm pore size. Inline filtration is also possible using 2-way Luer Lock filters. Reciprocating Holder Apparatus 7 and Accessories The Agilent Reciprocating Holder Apparatus 7 is ideal for automatic dissolution testing of dosage forms that require a change of media, a smaller volume or more vigorous agitation. Initially developed for testing transdermal patches, this apparatus now includes many different dosage form holders. The reciprocating holder has a stroke length of 20 mm and can be programmed to dip between 5 and 40 dips per minute. At the end of a designated time period, the dosage form is automatically transported from one row to the next. Typical products tested include extended release tablets, capsules, transdermals, osmotic pumps and arterial stents. The standard apparatus has seven reciprocating positions in each of the six rows and is available with 100 or 300 ml outer tubes. The firmware can be preprogrammed to automatically move to a fresh row of media for as many as six media changes. For an increased number of media changes or smaller volumes, the instrument is also available in a standard 12-position, 12-row configuration with a vessel size of 50 ml and an operational minimum of approximately 25 ml. The Dissolution Workstation Software can also be used to control and log events of an Apparatus 7 with an 8000 Sampling Station. By incorporating PC control, additional media changes can be accommodated by exchanging the vessel racks with fresh media. The Reciprocating Holder Apparatus 7: Simulates the biorelevant conditions for the skin, gastrointestinal tract and tissue required for transdermal, oral drugs and implants with biorelevant temperature agitation rates and retention times. Tests and transports a variety of samples, saving valuable bench space. Samples are automatically transported from one medium to the next without operator intervention, and can run unattended for up to six days. Stores up to 15 programs and maintains direct control over timepoints, agitation rate, sampling rate, and movement between vessel rows, hold dip time, and drain time. Accommodates a variety of dosage form holders including cylinders, reciprocating disks, angled disks, spring holders, stent holders, and pointed rods. Supports typical volume configurations of 50, 100 and 300 ml. Additional conversion kits are available that can transition the instrument to support different volumes. The standard 7-position, 6-row apparatus includes the following items: 3 outer media tube vessel carriers, 14-position 42 outer media tubes, 100 or 300 ml (USP) 1 external heater/circulator Printer Note: Select accessory kit to specify 100 or 300 ml outer tubes. The standard 12-position, 12-row apparatus includes the following items: 3 outer media tube vessel carriers, each carrier has 3 rows of 12 positions (36 total) 144 outer media tubes, (50 ml) 1 external heater/circulator Printer Note: Sample/dosage form holders must be ordered separately. 54

57 Dissolution Apparatus and Accessories Reciprocating Holder Apparatus 7 Apparatus 7, 7-row, 100/300 ml, 115V Apparatus 7, 7-row, 100/300 ml, 230V Apparatus 7, Alza, 12-row, 115V Apparatus 7, Alza, 12-row, 230V Apparatus 7, 12-row, 100/300 ml, 115V Apparatus 7, 12-row, 100/300 ml, 230V Reciprocating Holder Apparatus 7 Accessory Kits Choose one (1) of the following kits to accompany a 7-row Apparatus 7: Apparatus 7, 100 ml Accessory Kit Apparatus 7, 300 ml Accessory Kit Did You Know? The compatibility table on page 56 provides details on holders and outer tube volumes for your specific testing needs. Reciprocating Holder Apparatus 7 Accessories Pointed acrylic rod Transdermal patch holder kit Replacement acrylic rod kit cm 2 reciprocating disk cm 2 reciprocating disk cm 2 reciprocating disk cm 2 reciprocating disk cm 2 reciprocating disk Angled disk, 1.98 in Angled disk, 1.42 in Basket shaft, mini Basket, mini, 40-mesh Basket, mini, 50-mesh Basket assembly, titanium Spring holder, 1.45 in. L x 0.58 in. inner dia. x in. wire inner dia Spring holder, 1.40 in L x 0.31 in inner dia. x in. wire inner dia Spring holder, 0.96 in L x 0.33 in inner dia. x in. wire inner dia Spring holder, 0.60 in L x 0.25 in inner dia. x in. wire inner dia Spring holder, 1 in. L x 0.50 in. inner dia. x in. wire inner dia Spring holder, 1.45 in. L x 0.58 in. ID x in. wire inner dia Spring holder, 1.40 in. L x 0.31 in. ID x in. wire inner dia Spring holder, 0.96 in. L x 0.33 in. ID x in. wire inner dia Spring holder, 0.60 in. L x 0.25 in. ID x in. wire inner dia Spring holder, 1.00 in. L x 0.50 in. ID x in. wire inner dia Outer tube, 50 ml Outer tube, calibrated, 50 ml, class B Outer tube, 50 ml, amber

58 Dissolution Apparatus and Accessories BIO-DIS Reciprocating Cylinder and Reciprocating Holder Apparatus 7 Compatibility Table Reciprocating Holders Holder Apparatus 3 Outer Tube 50 ml 100 ml 300 ml (USP) 1000 ml Inner tube (300 ml) - - ] ] Inner tube (100 ml) - ] ] ] Basket, USP, 40-mesh, 381 µm - - ] ] Durafit basket adapter - NR ] ] Basket adapter with clip assembly - NR ] ] Apparatus 7 Outer Tube 50 ml 100 ml 300 ml (USP) 1000 ml Inner tube (300 ml) - - ] ] Inner tube (100 ml) - ] ] ] Durafit basket adapter - NR ] ] Basket adapter with clip assembly - NR ] ] Basket, mini, 40-mesh ] NR ] ] Basket, mini, 50-mesh ] ] ] ] Basket shaft, mini ] ] ] ] Basket assembly, titanium ] ] ] ] Pointed acrylic rod ] ] ] ] Replacement acrylic rod kit ] ] ] ] Transdermal patch holder kit - - ] ] cm 2 reciprocating disk ] ] ] ] cm 2 reciprocating disk - - ] ] cm 2 reciprocating disk - - ] ] cm 2 reciprocating disk - - ] ] cm 2 reciprocating disk NR NR ] ] Replacement stent holder ] ] ] ] Stent holder, 8 mm (horizontal) ] ] ] ] Stent holder, 18 mm (vertical) ] ] ] ] Stent holder, 30 mm (vertical) ] ] ] ] Spring holder, 1.40 in. L x 0.31 in. ]* ]* ]* ] inner dia. x in. wire inner dia Spring holder, 0.96 in. L x 0.33 in. ]* ]* ]* ] inner dia. x in. wire inner dia Spring holder, 0.60 in. L x 0.25 in. ]* ]* ]* ] inner dia. x in. wire inner dia Spring holder, 1 in. L x 0.50 in. ] ] ] ] inner dia. x in. wire inner dia Angled disk, 1.98 in ] Angled disk, 1.42 in ] Diamond image (]) = Compatible, Shaded box = Not compatible, NR = Not Recommended, Asterisk (*) = based on dimension measurements only 56

59 Dissolution Apparatus and Accessories 400-DS Apparatus 7 The first compendial small-volume dissolution testing apparatus for novel dosage forms 400-DS Dissolution Apparatus The 400-DS sets the performance standard for small-volume drug-release testing of medical devices such as drug eluting stents (DES) that release small amounts of active pharmaceutical ingredients (API) during a long period of time. Also used for testing extractables and leachables, and extended-release pharmaceutical products, the apparatus offers bathless heating, custom medical device holders, integrated autosampling, media replacement and liquid handling capabilities. Systems are available in sample cell sizes of 5 or 10 ml. Dissolution can be performed in volumes as low as 3 ml, providing significant gains in sample concentration for UV or LC analysis while virtually eliminating evaporation even when used with organic solvents. Controlled by its own version of the Dissolution Workstation Software, the 400-DS is capable of storing the operating parameters and method data required for a 21 CFR Part 11 environment. A relational database is used for test result storage, archival and retrieval. A single PC and software can control up to four systems. The 400-DS: Saves time by simultaneously testing up to 13 samples, or 12 samples and a control or standard, while providing users direct visibility of each dissolution cell Maintains temperature control through internal temperature probes and external heating jackets; no water bath is required Minimizes evaporation through the fully closed system and the integrated syringe pump and autosampler save valuable bench space Offers automated media addition/removal through a port on the bottom of the cell Enables sample holder reciprocation through an externally controlled magnetic plate and supports between 1 and 35 dips per minute (DPM) to best match your requirements Accommodates 12 individual sample rows with either 2 or 4 ml HPLC vials Allows you to program up to 36 timepoints and five different media types into a method, as the software prompts you for removal and replacement of the racks during the run Automates full or partial media replacement via a built-in fluidics module at every timepoint for each vessel Items included with a standard 400-DS: 400-DS base unit with syringe pump 400-DS Dissolution Workstation software 13 sample cells (5 or 10 ml) 13 heater jackets for sample cells Sample tray (13 individual rows) Sample vials (2 and 4 ml) for initial volume calibration Bottle caps and tubing for dissolution media/waste Modified temperature probe (for temperature calibration) Sample extraction tool Communication / power cables 57

60 Dissolution Apparatus and Accessories Dissolution Cell Design A glass tube, open at both ends, is placed on top of the fluidics module, and a heating jacket surrounds each tube (no water bath is required). The bottom end is capped by the sampling port, while the top end is sealed after the sample holder is inserted. All sampling and media replacement is performed from the sampling port at the bottom of the dissolution cell. Temperature is recorded and independently controlled using an integrated temperature probe at the bottom of each cell. The 400-DS supports the USP-specified stroke length of 20 ± 1 mm required for Apparatus DS Dissolution Apparatus DS cell holder with stent 400-DS, with PC, printer, software, 5 ml cell DS, 5 ml cell DS, with PC, printer, software, 10 ml cell DS, 10 ml cell DS Accessories Dissolution Workstation Software for 400-DS Dissolution cell, 10 ml Dissolution cell, 5 ml Dissolution cell, 5 ml, amber Dissolution cell, 10 ml, amber Heater element with cable assembly, 10 ml Heater element with cable assembly, 5 ml Vial tray row, single, 1.5 ml Vial tray row, single, 4 ml Extraction tool Vial, pre-crimped 12x32, 100/pkg Glass vial, clear, with PTFE/silicon cap, 15x45, 100/pkg Accessory kit, 10 ml Accessory kit, 5 ml (Continued) Internal view of cell holders 58

61 Dissolution Apparatus and Accessories 400-DS sample tray Did You Know? Agilent offers a variety of standard holders for stents, pacemaker leads, medicated contact lens, wound care products, and more. Contact your Agilent representative for information on custom-designed holders specifically for your testing needs. 400-DS Accessories 400-DS Sample Holders Stent holder assembly, 10 ml Stent holder assembly, 5 ml Accessory kit, holder for pacemaker lead, 1.7 mm Basket only assembly, 50-mesh Assembly kit, holder basket, 50-mesh Assembly kit, PEEK basket Basket only assembly, PEEK Basket, mesh end, 20 µm Assembly, punctal plug holder, 5 ml Assembly, contact lens holder, 5 ml Assembly, flat blank holder, 10 ml Assembly, contact lens holder, 5 ml, 16 mm DS Dimensions Height Width Depth Weight cm / 23 in cm / 21 in cm / 23.5 in kg / 130 lb. 400-DS Specifications Reciprocation length 20.0 ± 1.0 mm Dip Rate 1-35 ± 0.5% DPM Temperature Ambient + 5 to 50 ± 0.2 C Volume (Media) 3-5 (5 ml cell) or 8-12 (10 ml cell) ± 1% Volume (Sample) 2 or 4 ml tray ± 1% Timepoint (samples) Specified as HHH:MM:SS ± 2% Test Duration 1 hour to 28 days Number of Timepoints Up to 36 (with tray change) Number of Samples (per test) 1 to 13 Input Voltage 115V / 230V AC; 50 / 60 Hz Types of Media (per test) Up to 4 plus rinse Evaporation 0.2% or better over 24 hours 400-DS sample holders 59

62 Dissolution Apparatus and Accessories Rotating Bottle Apparatus and Accessories Rotating Bottle Redesigned Rotating Bottle Apparatus The Rotating Bottle Apparatus was redesigned in 2002 and many of the original accessories are no longer manufactured. Therefore, you may need to purchase caps, screens, and/or liners in addition to new bottles. The Rotating Bottle Apparatus is one of the initial drug release apparatus, first appearing in the US National Formulary (NF) XIV specifications and designed for release rate testing of tablets or pellets, as well as implants. Bottles are clipped into a rotating shaft which is immersed in a water bath and rotated at the preprogrammed speed. The manual changing of media during a test simulates a dosage passing through a ph gradient. Sealed bottles prevent evaporative loss, and a variety of bottle and vial sizes are available. The rotational speed can be selected between 10 and 60 RPM (± 2 RPM), and the speed is shown on the LED display. The water bath temperature is controlled by an external heater/circulator and provides a stable environment within ± 0.2 C of the set temperature. The standard Rotating Bottle Apparatus includes: Standard apparatus with water bath and heater/circulator 14 Clips for 100 ml bottles 20 Rotating bottles, clear, 100 ml 20 Caps with Viton liners 5 Decanting caps 1 Thermistor probe Note: The Rotating Bottle Apparatus is sold with or without a heater/circulator. A variety of accessories and replacement parts are available for the Rotating Bottle Apparatus, including smaller and larger volume bottles, amber bottles, caps, liners, screens and conversion kits. A standard conversion kit is the upgrade from 100 to 200 ml amber bottles, which includes: 4 Delrin spacers with hardware 14 Clips for 200 ml bottles 20 Amber bottles, 200 ml 5 Decanting caps 60

63 Dissolution Apparatus and Accessories Rotating Bottle Apparatus Rotating Bottle Apparatus, with heater/circulator, 115V Rotating Bottle Apparatus, with heater/circulator, 230V Rotating Bottle Apparatus, without heater/circulator, 115V Rotating Bottle Apparatus, without heater/circulator, 230V Rotating bottle with cap Rotating Bottle Accessories Conversion Kits Conversion kit, amber, 200 ml Conversion kit, 4 in. center shaft extensions, 16x100 mm tubes Bottle Caps Cap, with Viton liner, for 100 ml Cap, with Viton liner, for 200 ml Decanting cap, with 40-mesh screen, for 100 ml Decanting cap, with 40-mesh screen, for 200 ml Screens and Liners Viton liner, for 100 ml Viton liner, for 200 ml Replacement screen, for decanting cap, 40-mesh, for 100 ml Replacement screen, for decanting cap, 40-mesh, for 200 ml Clips Bottle clips, for 100 ml Bottle clips, for 16x100 mm tubes Bottle clips, for 28x98 mm (40 ml) tubes Bottle clips, for 200 ml Bottles Bottle, with cap, 100 ml Bottle, with cap, amber, 100 ml Bottle, with cap, amber, 200 ml Bottle only, amber, 100 ml Bottle only, 100 ml Rotating Bottle Apparatus Dimensions Height Width Depth Weight cm / 24 in cm / 19 in cm / 15.3 in kg / 31 lb, without bottles and water bath 61

64 Dissolution Software Dissolution Workstation Software Complete, integrated control of multiple dissolution systems from a single computer Supported Apparatus Agilent's complete line of dissolution equipment is available for use with Dissolution Workstation Software. This includes: 708-DS, 709-DS and discontinued apparatus (Apparatus 1 and 2) BIO-DIS Reciprocating Cylinder and Apparatus 7 Reciprocating Holder (Apparatus 3 and 7) 806 Syringe Pump, 808 Filter Changer and 810 Peristaltic Pump 8000 Dissolution Sampling Station and 8020 Dissolution Sampling/HPLC Injector Dissolution Workstation Software integrates Agilent s dissolution apparatus and automated sampling components, allowing you to simultaneously control up to four systems of any configuration from a desktop PC. The software provides a mechanism for the user to build, edit, search, retrieve, and archive all dissolution methods and test reports from a single interface. Method parameters, instrument and accessory information, and test data are captured and recorded with the software. View test status information in real time as the software progresses through the timepoints for each dissolution system. As part of 21 CFR Part 11 compliance, user changes to methods and system configurations can be easily tracked and documented. Agilent s complete line of dissolution equipment is available for use with the Dissolution Workstation Software. This includes Apparatus 1, 2, 3, 5, 6 and 7 and the associated pumps and automated sampling equipment. The Dissolution Workstation Software maintains a complete history for all executed tests, which can be digitally verified and electronically signed. Print, preview or export PDFdocumented results generated by a dissolution run in the protected database created locally or on a network. The client-server architecture offers the potential to integrate or export the data to a laboratory information management system (LIMS). Dissolution Workstation Software Dissolution Workstation Software

65 Dissolution Software The Dissolution Workstation Software: Contains seven different user groups to assign proper rights and privileges to individual users Includes an audit trail feature that creates test reports highlighting differences between versions of methods or system configurations Can support dissolution methods that include a media change Does not have restrictions on the different combinations of equipment with any of four systems that may be configured Offers an ideal solution to eliminating manual transcription errors, and improving efficiency and data integrity Dissolution Workstation Software 63

66 Calibration and Verification Tools QAII C Mechanical Qualification Station Measure and document critical physical parameters for most all brands of dissolution apparatus QAII C Mechanical Qualification Station Eliminate the guesswork. The digital measurement of physical parameters is easy with the portable, calibrated QAII C Mechanical Qualification Station. Designed for the 21 CFR Part 11 environment, the system measures vibration, spindle rotational speed (RPM), shaft and vessel verticality, shaft These highly precise devices are individually calibrated with NIST traceability for reliable mechanical qualification of physical parameters. With the use of the adapter ring and access to the shaft and vessel in operating mode, taking measurements of paddles and basket components in a variety of dissolution apparatus from most manufacturers. Test data printouts from the on-board printer include serial numbers, parameters and space for operator and approval signatures. Alternatively, you may download the data to a Microsoft Excel spreadsheet to review, approve and retain your mechanical qualification data. The QAII C includes: Base unit with keypad, LCD screen and printer Digital wobble gauge Magnetic RPM sensor Electronic level sensor (also measures shaft/vessel verticality) Precision temperature probe Electronic vibration sensor Universal adapter for use with apparatus without EaseAlign centering systems Calibrated shaft Molded plastic carrying case for safe storage and transportation of your instrument Shaft verticality measurement taken with the QAII C Mechanical Qualification Station A specially designed bracket holds a wobble gauge and magnetic tachometer. The wobble gauge displays wobble in millimeters, while the magnetic tachometer records the agitation rate in RPM with the aid of a magnetic clip attached to the paddle or basket shaft. An electronic level sensor measures and displays in degrees the level of the vessel table, as well as the verticality of each shaft and vessel. To verify vessel and water bath temperature, a calibrated temperature probe is included. The QAII C measures the four parameters of vibration: acceleration (g force), frequency (Hz), velocity (mm/sec.) and displacement (mm). These vibration parameters can be measured in X, Y, and Z vectors by rotating the vibration sensor. In addition to taking vibration measurements on the vessel plate and drive unit, environmental vibration may also be measured on the laboratory bench. The QAII C comes with a certificate of calibration, and annual or biannual recalibration is highly recommended. While the QAII Station is now obsolete, it may be upgraded. The upgrade includes the new firmware chip and the disk containing the spreadsheet application. The QAII C upgrade allows data capture and retention in 21 CFR Part 11 environments. 64

67 Calibration and Verification Tools QAII C Mechanical Qualification Station Dimensions Height Width Depth Weight cm / 7.25 in cm / 8.75 in cm / 7.75 in kg /5.3 lb, without attachments Vessel verticality measurement with the QAII C QAII C Mechanical Qualification Station Accessories QAII C station, 115V QAII C station, 230V Carrying case, hard plastic QAII C calibration, with calibration certificate Upgrade, magnetic sensor plus calibration Upgrade, QAII to QAII C Recalibration The QAII C and Agilent 5010 (see page 66) should be periodically recalibrated, and Agilent offers this service from the Cary, NC facility. To schedule your instruments for recalibration, visit dissolution3in1 QAII C Mechanical Qualification Station Replacement Parts Adapter, universal for QAII and QAII C Calibration shaft, with certification Reflective RPM sensor clip, black Reflective RPM sensor clip, white Magnetic RPM sensor clip, for 1/4 dia. shaft Magnetic RPM sensor clip, for 3/8 dia. shaft Printer paper, 10 rolls/pkg Printer paper, 100 rolls/pkg Ribbon cartridge, 5/pkg

68 Calibration and Verification Tools Agilent 5010 Height/Center Qualification Station Fast and convenient height and centering measurements required by Mechanical Qualification standards 5010 Height Center Qualification Station The Agilent 5010 Height/Center Qualification Station is a portable system for digitally measuring shaft centerline offset and paddle/basket height with NIST-traceable gauges. The precision-engineered measuring devices produce highly accurate measurements and ensure technicians no longer have to interpret distances or rely on visual estimation common with manual gauges. Accurate measuring of shaft centering within the dissolution vessel is easily performed without the use of surrogate shafts or vessels required for some non-agilent dissolution apparatus. Similarly the true height from the lowest point in the bottom of the vessel to the bottom of the basket or paddle can now be accurately measured. The clearly visible LCD panel prompts you to move the devices from one position to another and displays the results as measurements are taken. You can also view completed results on the LCD display or get hardcopy printouts using the on-board printer. For added versatility, you may use the battery-powered option for portability from apparatus to apparatus to test the height and centering on most dissolution apparatus. The 5010 uses non-volatile memory to store critical test-specific information for up to 30 dissolution apparatus (a maximum of eight vessels per apparatus). Stored information includes individual measurements as well as: Instrument ID Shaft IDs Vessel IDs Number of vessel positions Agilent 5010 Height/Center Qualification Station 5010 Height/Center Qualification Station, with printer, 115/230V Carrying case, hard plastic calibration, with certificate Centering measurement (top) and height measurement (bottom) taken with the Agilent Height/Center Qualification Station Dimensions Height Width Depth Weight 18.5 cm / 7.25 in cm / 9.5 in cm / 7.75 in. 3 kg / 6.6 lb 66

69 Calibration and Verification Tools Verification Tools Tools to manually set and verify height/depth, wobble, RPM and centering For fast, efficient and manual physical parameter setting verification, Agilent offers several tools designed for use with the 708-DS and 709-DS, as well as older model apparatus still in use. Height, Centering and Spacer Tools and Gauges Each of these tools ensure your paddles and baskets are set properly for operation. In addition to height and centering, the tools offer correct spacing from the bottom of the dissolution vessel to the accessory in use such as a paddle or basket. Shaft Wobble Gauge Designed to work with the EaseAlign rings, these gauges indicate shaft wobble in 0.01 millimeter graduations and include a snap-in adapter for non-easealign instruments. Height spacer for paddles Tachometer, Handheld The handheld tachometer measures RPM with continuous updates each second. The measured value can be stored and read on the display by use of a slide switch. The instrument, powered by a 9V battery, includes conical and disk tips. The range is 6 to 99,000 rpm with an accuracy of ± 0.4% ± 1 digit. 67

70 Calibration and Verification Tools A Verification Tools Height Spacers for USP Apparatus 1 and 2 Height spacer, for 100 and 200 ml, 3.25 in., for 7000/7010 only(image A) Height spacer, for baskets (image B) Height spacer, for paddles (image C) Height spacer, for paddle and 100 and 200 ml round bottom vessels, 15 mm, for 7000/7010 only Height spacer, for Peak vessels (image D) Height spacer, for use with paddles, ball without retrieval string, 25 mm (image E) Height spacer, for use with paddles, ball with retrieval string, 25 mm Height spacer, for use with paddles, ball with retrieval string, 25 mm, V with certificate Height spacer, for use with intrinsic apparatus, ball with retrieval string, 38 mm Height spacer, for use with intrinsic apparatus, ball with retrieval string, 38 mm, V with certificate Height spacer, for attachment to paddles, 25 mm above bottom of vessel Height spacer, for attachment to paddles, 25 mm above bottom of vessel, V with certificate Height spacer, for attachment to basket shaft, 25 mm above bottom of vessel(image F) Height spacer, for attachment to basket shaft, 25 mm above bottom of vessel, V with certificate Height gauge, Rotating Cylinder (Continued) F B C D E Height spacers 68

71 Calibration and Verification Tools A Vessel centering tools C Height tools D F G H (Left to right) Digital gauge, analog gauge and tachometer E B Verification Tools Height and Centering Tools for USP Apparatus 1 and 2 Vessel centering tool, for stainless steel centering ring (image A) Vessel centering tool, pass/fail gauge for use with EaseAlign centering rings (image B) Vessel centering tool, pass/fail gauge for use with EaseAlign centering rings, V with certificate Height tool, stainless steel, sets height of basket and paddles, 25 mm (image D) Height tool, stainless steel, sets height of basket and paddles, 25 mm, V with certificate Height tool, stainless steel, sets height of basket and paddles, for 2L vessels, mm (image C) Height tool, stainless steel, sets height of basket and paddles, for 2L vessels, V 25 mm, with certificate Height tool, stainless steel, sets height of basket and paddles, used for testing antibiotics, 45 mm Height tool, stainless steel, sets height of basket and paddles, used for testing V antibiotics, 45 mm, with certificate Height tool, stainless steel and Delrin, for Peak vessels (image E) Bubble level, for horizontal centering Shaft Wobble Gauges Digital wobble gauge, with EaseAlign fitting (image F) Analog wobble gauge, 0.01 mm (image G) Calibration certificate, for thickness and wobble gauge Tachometers and Timer Tachometer (image H) Calibration certificate, for handheld tachometer Calibration certificate, with data sheet, for handheld tachometer Calibrated timer, with certificate

72 Automated Dissolution Sampling Systems Agilent 8000 Dissolution Sampling Station Simplified and Reproducible Automated Dissolution Sample Collection Agilent 8000 Dissolution Sampling Station with septumcapped vial tray. The Agilent 8000 Dissolution Sampling Station provides a proven, reliable solution to set up and execute dissolution tests and automated sampling. Dissolution method parameters are entered and stored in the 8000 while allowing unattended, repeatable sample filtration and collection according to regulatory requirements. Sampling systems are available in 6-, 8- or 12-valve configurations based on the number of active positions on the dissolution apparatus. The Agilent 8000 can be configured with the pump of your choice 806 Syringe Pump or 810 Peristaltic Pump depending on the volume accuracy, timepoint frequency and the filtration required for the dissolution samples. Using the 806 Syringe Pump option also allows for the addition of the 808 Filter Changer for filtering down to 0.45 µm using 25 mm automation-friendly filters. All versions of Agilent dissolution apparatus, including Apparatus 1, 2, 3, 5, 6 and 7, as well as non-agilent models, can be used with the Agilent 8000, removing analyst sampling variability and allowing for testing outside of the normal workday for a variety of instrumentation. The media replacement option of the Agilent 8000 can also be added to maintain a consistent vessel volume as samples are removed throughout the dissolution test. 708-DS Dissolution Apparatus, 806 Syringe Pump, 808 Filter Changer and 8000 Dissolution Sampling Station 70

73 Automated Dissolution Sampling Systems Minimize Hydrodynamic Disturbance and Improve Sampling Accuracy Configuring the Agilent 8000 with an Agilent dissolution apparatus and motorized manifold eliminates the need for manual sampling and reduces hydrodynamic disturbance from the sampling cannulas. The automated manifold is lowered only at the time of sampling and can be programmed to sample at an exact location based on vessel volume and apparatus installed. Key Benefits of the 8000 Dissolution Sampling Station Unattended dissolution sampling to increase reproducibility and free up analyst time Multiple configurations available including peristaltic pump, syringe pump, or syringe pump with filter changer Septum piercing capability allows sample storage in sealed HPLC vials or test tubes Stores 15 programs with up to 10 timepoints for each method, and 20 timepoints are possible by replacing the sample tray at the appropriate prompt Easy calibration routines to regularly calibrate volume accuracy Patented autocalibration block is used in conjunction with the 810 Peristaltic Pump to ensure volume accuracy Individual sampling lines and collection tubes/vials to prevent cross-contamination Complete documentation for each test using the built-in printer, including the test parameters from the dissolution apparatus Various sample tray sizes available to incorporate test tubes or capped LC vials Optional automated media replacement available to maintain vessel volumes Thoroughly flush the sample lines between tests using the Clean System function Configurable with 708-DS, 709-DS and BIO-DIS, as well as other Agilent and non-agilent dissolution apparatus PC control of up to four (4) dissolution systems (including the 8000 Sampling Station) is available using the Dissolution Workstation software 8000 Dissolution Sampling Dimensions Height Width Depth Weight 8000 Dissolution Sampling Station cm / in cm / 17 in cm / in kg / 36 lb. 806 Syringe Pump 29.2 cm / 11.5 in cm / 9.5 in cm / 6 in. 5.8 kg / 12.9 lb. 808 Filter Changer 45.1 cm / in cm / 9.5 in cm / 17.5 in kg / 31.2 lb. 810 Peristaltic Pump cm / 5.5 in cm / 6 in cm / 18 in. 6.9 kg / 15.2 lb 8000 Dissolution Sampling Station Specifications Sample Accuracy ± 0.5 ml (810 Peristaltic Pump) ± 0.2 ml (806 Syringe Pump) ± 0.3 ml (806 Syringe Pump/808 Filter Changer) Number of Samples (per test) 1 to 20 (requires tray changer after 10) Volume (Sample) 1 to 14 ml Test Duration up to 999 hours Number of Programs (stored) up to 15 Input Voltage 115V / 60Hz or 230V / 50 Hz 71

74 Automated Dissolution Sampling Systems The Agilent 8000 may be configured with a peristaltic pump, syringe pump, or syringe pump with filter changer. Use the following Ordering Matrix to select the appropriate part number based on voltage, number of positions, manifold configuration (if applicable) and desired pump components. Then, select an accessory kit based on desired sample tray size to complete the configuration. Each part number in the matrix below includes an 8000, the specified accessories, sample tubing, and communication cables Dissolution Sampling Station and Accessory Ordering Matrix 810 Peristaltic Pump 806 Syringe Pump/808 Filter Changer Voltage # Positions Manifold Configuration 806 Syringe Pump Ordering an Agilent 8000 for 115V 6-Valve 3 x configuration with a 7000/ x The sampling manifold and motor drive are included. The configuration 8-Valve 4 x of the sampling manifold is based on 230V 6-Valve 3 x the vessel positions of your 7000 or 4 x Valve 4 x Ordering an Agilent 8000 for configuration with a 705-DS*, 708-DS*, 7025/7030, or non-agilent apparatus** 115V 6-Valve N/A Valve N/A V 6-Valve N/A Valve N/A Ordering an Agilent 8000 for 115V 8-Valve N/A configuration with a BIO-DIS 12-Valve N/A Reciprocating Cylinder or Reciprocating Holder 230V 8-Valve N/A Apparatus 7 12-Valve N/A Include the appropriate accessory kit part number below to accompany the 8000: 8000 Accessory Kit includes sample tray, Full Flow 6 or 8-Valve 16 x 100 mm Tray Filter sample packs, package of test tubes/vials 12 x 32 mm Tray Valve 12 x 32 mm Tray *Ensure the 705-DS or 708-DS to be configured with the 8000 includes a sample manifold or resident probe sampling kit. Note: Non-Agilent apparatus will require the addition of a compatible resident probe sampling kit. See page 21 for ordering information. **A manifold is not included and resident sampling probes must be used. See the example on the right of a 709-DS with 6 positions, set up for paddles and baskets, DDM option, 8000 Dissolution Sampling Station, 806 Syringe Pump, 808 Filter Changer at 230V. Note: The AutoTemp option is standard on the 709-DS. 709-DS and Autosampling Ordering Example Quantity DS system, DDM, sampling and temperature, 6-position , 6-valve, with 806 Syringe Pump / 808 Filter Changer, 230V accessory kit with 16x100 mm sample tray, Full Flow Filter sample packs, package of test tubes/vials, 6-or 8-valve 6 Paddle, lower interchangeable, electropolished stainless steel Basket shaft clip, lower interchangeable, standard USP Basket, USP, 40-mesh, 381 µm

75 Automated Dissolution Sampling Systems Did You Know? Several vessel plate configurations were available with the 7000/7010 Dissolution Apparatus. To help distinguish: 3x3 indicates 2 rows of 3 vessels 4x2 indicates 2 rows of 4 vessels with 6 active spindle locations (back 2 middle positions empty) 4x4 indicates 2 rows of 4 vessels with 8 active spindle locations 8000 Dissolution Sampling Station and Sampling System Enabled for use with the 705-DS, 708-DS, 7025, and 7030 Dissolution Apparatus 8000, 6-valve, with 810 Peristaltic Pump, 115V , 6-valve, with 810 Peristaltic Pump, 230V , 8-valve, with 810 Peristaltic Pump, 115V , 8-valve, with 810 Peristaltic Pump, 230V , 6-valve, with 806 Syringe Pump, 115V , 6-valve, with 806 Syringe Pump, 230V , 8-valve, with 806 Syringe Pump, 115V , 8-valve, with 806 Syringe Pump, 230V , 6-valve, with 806 Syringe Pump / 808 Filter Changer, 115V , 6-valve, with 806 Syringe Pump / 808 Filter Changer, 230V , 8-valve, with 806 Syringe Pump / 808 Filter Changer, 115V , 8-valve, with 806 Syringe Pump / 808 Filter Changer, 230V Enabled for use with the 7000 and 7010 Dissolution Apparatus 8000, 3x3, 6-valve, with 810 Peristaltic Pump, 115V , 4x2, 6-valve, with 810 Peristaltic Pump, 115V , 3x3, 6-valve, with 810 Peristaltic Pump, 230V , 4x2, 6-valve, with 810 Peristaltic Pump, 230V , 4x4, 8-valve, with 810 Peristaltic Pump, 115V , 4x4, 8-valve, with 810 Peristaltic Pump, 230V , 3x3, with 806 Syringe Pump, 115V , 4x2, with 806 Syringe Pump, 115V , 4x4, with 806 Syringe Pump, 115V , 3x3, with 806 Syringe Pump, 230V , 4x2, with 806 Syringe Pump, 230V , 4x4, with 806 Syringe Pump, 230V , 3x3, with 806 Syringe Pump / 808 Filter Changer, 115V , 4x2, with 806 Syringe Pump / 808 Filter Changer, 115V , 3x3, with 806 Syringe Pump / 808 Filter Changer, 230V , 4x2, with 806 Syringe Pump / 808 Filter Changer, 230V , 4x4, with 806 Syringe Pump / 808 Filter Changer, 115V , 4x4, with 806 Syringe Pump / 808 Filter Changer, 230V , 3x3 for 2L, with 806 Syringe Pump, 115V , 3x3 for 2L, with 806 Syringe Pump, 230V , 4x4 for 2L, with 806 Syringe Pump, 115V , 4x4 for 2L, with 806 Syringe Pump, 230V (Continued) 73

76 Automated Dissolution Sampling Systems 8000 Dissolution Sampling Station and Sampling System Sampling trays with HPLC septum-capped vials (top) and glass tubes (bottom). Enabled for use with the BIO-DIS Reciprocating Cylinder Apparatus 8000, 8-valve, for BIO-DIS, with 810 Peristaltic Pump, 115V , 8-valve, for BIO-DIS, with 810 Peristaltic Pump, 230V , 4x4, for BIO-DIS, with 806 Syringe Pump, 115V , 4x4, for BIO-DIS, with 806 Syringe Pump, 230V , 8-valve, for BIO-DIS, with 806 Syringe Pump / 808 Filter Changer, 115V , 8-valve, for BIO-DIS, with 806 Syringe Pump / 808 Filter Changer, 230V Enabled for use with the Reciprocating Holder Apparatus 7 and Custom 12-Tube Apparatus , 12 valve, with 810 Peristaltic Pump, for App. 7, 115V , 12-valve, with 810 Peristaltic Pump, for App. 7, 230V Accessories for 8000 Dissolution Sampling Station Media replacement option, internal (specify printer type) Media/rinse chamber Printer, retrofit kit Stacking rack, for Autocalibration fixture Peristaltic Pump replacement cartridge Dual loop, 810 Peristaltic Pump kit with 6 cartridges Dual loop, 810 Peristaltic Pump kit with 8 cartridges Adapters, to connect Teflon to 810 Peristaltic Pump tubing, 24/pkg Nut and ferrule, 1/4-28, for 1/16 in. inner dia. Tubing Trays for 8000 Dissolution Sampling Station Sampling tray, open tube, 16x100 mm Sampling tray, open tube, 15x100 mm Sampling tray, open tube, 15x85 mm Sampling tray, HPLC, 8x30 mm Sampling tray, HPLC, 7x40 mm Sampling tray, HPLC, 8x40 mm Sampling tray, HPLC, 12x32 mm Sampling tray, HPLC, 15x45 mm, for 8020 only Sampling tray, HPLC, 12x32 mm, for 8020 only Sampling tray, HPLC, 15x45 mm Sampling tray, HPLC, 13x75 mm Sampling tray, HPLC, 13x100 mm Sampling tray, HPLC, 12x75 mm Acrylic rinse tray, 6 vessels, 3x3, for 7000/ Acrylic rinse tray, 7-8 vessels, for 7000/ Acrylic rinse tray, for 708-DS/709-DS (Continued) Acrylic rinse trays 74

77 Automated Dissolution Sampling Systems 8000 Dissolution Sampling Station and Sampling System HPLC septum-capped vials (top) and glass tubes (bottom) Replacement Accessories for 8000 Dissolution Sampling Station Sampling cannula, 4.5 in. (for 7000/7010 manifold) Sampling cannula, 6.5 in., for 500 ml in 1L vessel (for 7000/7010 manifold) Cannula extension kit, 500 ml (for one cannula) Sampling cannula, 8.12 in., for 2L vessel (for 7000/7010 manifold) Sampling cannula, 10 in., for 4L vessel (for 7000/7010 manifold) Adapter, manual sampling cannula, for PNs and Manual sampling cannula assembly, 500 ml Manual sampling cannula assembly, 900 ml Sampling cannula, for 7025/ Return cannula, for 7025/ Manual sampling cannula, for sampling through apparatus head on 7025/ Return cannula, 2 1/4 in Tubes, Vials and Needles for 8000 Dissolution Sampling Station Glass tubes, 16x100 mm, 250/pkg Glass tubes, 15x85 mm, 1000/pkg Glass vial, clear, 12x32, with cap, PTFE/silicon, 100/pkg Glass vial, clear, with PTFE/silicon cap, 15x45, 100/pkg Glass vial, amber, with PTFE/silicon cap, 15x45, 100/pkg Calibration tubes, 10 ml, 8/pkg Replacement needles, long, 3/pkg Replacement needles, short, 3/pkg Replacement valve kit, long needle Replacement valve kit, short needle Replacement Tubing for 810 Peristaltic Pump Purple/white Marprene replacement tubing, 8/pkg Purple/white Viton replacement tubing, 8/pkg White silicone replacement tubing, 8/pkg Replacement Colored Tubing for Peristaltic/Syringe Pumps (without fittings) Tubing, colored Teflon, for 3x3, for use with 810 Peristaltic Pump, in. dia., lengths of 50 ft. Tubing, colored Teflon, for 4x2, for use with 810 Peristaltic Pump, in. dia., lengths of 50 ft. Tubing, colored Teflon, for 4x4, for use with 810 Peristaltic Pump, in. dia., lengths of 50 ft. Tubing, colored Teflon, for 3x3, for use with 806 Syringe Pump, in. dia., lengths of 50 ft. (Continued) 75

78 Automated Dissolution Sampling Systems 8000 Dissolution Sampling Station and Sampling System Color-coded Clear Tubing for 8000 Dissolution Sampling Station Tubing assembly, flared, sampling cannula, 8-valve Tubing assembly, flared, return cannula, 8-valve Tubing assembly, flared, return, 8-valve Tubing assembly, flared, sampling, 8-valve Tubing assembly, flared, sampling, 8-valve, for 810 Peristaltic Pump Tubing assembly, flared, sampling cannula valve, 3x Tubing assembly, flared, return cannula valve, 3x Tubing assembly, flared, sampling cannula valve, 4x Tubing assembly, flared, return cannula valve, 4x Tubing assembly, flared, return 6-valve Tubing assembly, flared, sampling 6-valve Tubing assembly, flared, pump to 6-valve Tubing assembly, flared, for 806 Syringe Pump / 808 Filter Changer, 6-valve Tubing assembly, flared, for 806 Syringe Pump / 808 Filter Changer, 8-valve Tubing assembly, 2L, sampling cannula valve, 4x Tubing assembly, 2L, return cannula valve, 4x Tubing assembly, 2L, sampling cannula, 8-valve Tubing assembly, 2L, return cannula, 8-valve Tubing assembly, 2L, sampling cannula valve, 3x Tubing assembly, 2L, return cannula valve, 3x Tubing assembly, 2L, return cannula, 8-valve, for Cary Tubing assembly, sampling cannula, 8-valve, for Cary Tubing assembly, sampling/return, 8-valve, for 7025/ Tubing assembly, sampling/return, 6-valve, for 7025/ Tubing assembly, return cannula, 12x12, for BIO-DIS Tubing assembly, sampling cannula, 12x12, for BIO-DIS Tubing assembly, male/female, 12x12, for BIO-DIS Tubing assembly, male lure for 810 Peristaltic Pump, 12x12, for BIO-DIS Tubing assembly, return valve, 12x12, for BIO-DIS Tubing assembly, barbed fitting, 12x12, for BIO-DIS Tubing assembly, sampling valve, 12x12, for BIO-DIS Tubing assembly, 1L, sampling cannula, 6-valve, for 708-DS Tubing assembly, 1L, return cannula, 6-valve, for 708-DS Tubing assembly, 1L, sampling cannula, 8-valve, for 708-DS Tubing assembly, 1L, return cannula, 8-valve, for 708-DS Tubing assembly, 2L, sampling cannula, 6-valve, for 708-DS Tubing assembly, 2L, return cannula, 6-valve, for 708-DS Tubing assembly, 2L, sampling cannula, 8-valve, for 708-DS Tubing assembly, 2L, return cannula, 8-valve, for 708-DS (Continued) 76

79 Automated Dissolution Sampling Systems 8000 Dissolution Sampling Station and Sampling System Color-coded Clear Tubing for 8000 Dissolution Sampling Station Tubing assembly, 8 flared, male to female, 72 in Tubing assembly, 6 flared, male to female, 72 in Tubing assembly, 8 double flared, male to male, 72 in Tubing assembly, 6 double flared, male to male, 72 in Tubing assembly, sampling cannula valve, 3x3, 200 ml Tubing assembly, return cannula valve, 3x3, 200 ml Tubing assembly, sampling cannula valve, 4x2, 200 ml Tubing assembly, return cannula valve, 4x2, 200 ml Tubing assembly, sampling cannula valve, 4x4, 100 ml Tubing assembly, return cannula valve, 4x4, 100 ml Tubing assembly, sampling cannula valve, 4x2, 100 ml Tubing assembly, return cannula valve, 4x2, 100 ml Tubing assembly, for 1L 708-DS, sample and return cannulas, 6-position Tubing assembly, for 1L 708-DS, sample and return cannulas, 8-position Tubing assembly, for 2L 708-DS, sample and return cannulas, 6-position Tubing assembly, for 2L 708-DS, sample and return cannulas, 8-position Tubing assembly, sampling cannula valve, 3x3, 100 ml Tubing assembly, return cannula valve, 3x3, 100 ml Tubing assembly, female/lure to sample cannula, 8-valve, for BIO-DIS Tubing assembly, male/lure to male ¼-28, 8-valve, for BIO-DIS Tubing assembly, female ¼-28 to return cannula, 8-valve, for BIO-DIS Dissolution Sampling Station Base Station only (no pump) 8000 Dissolution Sampling Station, 6-valve, 115V Dissolution Sampling Station, 8-valve, 115V Dissolution Sampling Station, 6-valve, 230V Dissolution Sampling Station, 8-valve, 115V

80 Automated Dissolution Sampling Systems Agilent 806 Syringe Pump The Agilent 806 Syringe Pump draws samples from an Agilent dissolution and drug release apparatus and ensures precise sample volumes. The Agilent 806 utilizes completely inert sample contact materials consisting of stainless steel, glass, Teflon and PEEK materials. Precise sample volumes (± 0.2 ml) Available with 10.0 ml syringes Uses Teflon tubing and PEEK valves, making the sample pathway inert Used with the optional 808 Filter Changer to filter samples down to 0.45 µm pore size Can be used to pull samples with the 8000 Dissolution Sampling Station or Cary 60 UV Dissolution Systems 806 Syringe Pump The 806 Syringe Pump provides exceptional sampling accuracy (± 0.2 ml standalone or, ± 0.3 ml in combination with the 808 Filter Changer). The minimum time between sampling timepoints is 5 minutes, or 6 minutes with the 808 Filter Changer. Although a complete Agilent solution provides the best use of system features, it is not required. The 806 Syringe Pump with 8000 Dissolution Sampling Station may also be configured with a non-agilent instrument to automate dissolution sampling using a resident probe setup. 806 Syringe Pump 806 Syringe Pump, 8-channel, 115V Syringe Pump, 6-channel, 115V Syringe Pump, 8-channel, 230V Syringe Pump, 6-channel, 230V Syringe Pump Dimensions and Specifications Height Width Depth Weight 29.2 cm / 11.5 in cm / 9.5 in cm / 6 in. 5.8 kg / 12.8 lb. Sampling Accuracy (with Agilent 8000) Sampling Accuracy (with Agilent 8000 and 808 Filter Changer) ± 0.2 ml for 10 ml sample ± 0.3 ml for 10 ml sample 78

81 Automated Dissolution Sampling Systems Agilent 808 Filter Changer The dissolution process does not stop until all undissolved drug has been removed from the sample. The Agilent 808 Filter Changer is used in line to filter down to 0.45 µm to ensure your sample is adequately filtered. The 808 is designed to filter six, seven, or eight lines simultaneously and can store up to 200 filters at a time. The filters are automatically changed between timepoints to prevent filter clogging. The Agilent 808 is used in conjunction with the 806 Syringe Pump and can easily be added to an existing configuration that includes the 8000 Dissolution Sampling Station. 808 Filter Changer Combining the 808 Filter Changer with 8000 Dissolution Sampling Station and 806 Syringe Pump When used with the Agilent 8000, all of the parameters are set using the 8000 keypad. You are assured of the proper sample volume being withdrawn due to the accuracy of the 806 Syringe Pump. These syringes provide a sampling accuracy of ± 0.3 ml when used with the filter changer. An 808 Filter Changer can be retrofitted to an existing Agilent 8000 being used with the 810 Peristaltic Pump. For these systems, an 806 Syringe Pump and 808 Filter Changer can be easily switched with the existing pump. Automatic filter changing between each sample timepoint Special 25 mm filters designed for automation, plus a full range of filter tips. Special automation ready 25 mm filters with pore sizes down to 0.45 µm are available (see page 38) Filters may be exchanged every one or two sampling timepoints 6- or 8-channel system option to meet your exact laboratory needs Can be used to filter samples with the 8000 Dissolution Sampling Station or Cary 60 UV Dissolution Systems 808 Filter Changer 808 Filter Changer, 8-channel, 115V Filter Changer, 6-channel, 115V Filter Changer, 8-channel, 230V Filter Changer, 6-channel, 230V Filter Changer Dimensions and Specifications Height Width Depth Weight 45.1 cm / in cm / 9.5 in cm / 17.5 in kg / 31.2 lb. Sampling Accuracy (with Agilent 8000 and 806 Syringe Pump) ± 0.3 ml for 10 ml sample 79

82 Automated Dissolution Sampling Systems Agilent 810 Peristaltic Pump The flexible, bi-directional Agilent 810 Peristaltic Pump has a 16-channel maximum capacity for sample transfer in Agilent dissolution sampling systems. The 8-roller design creates a smooth flow while priming, sampling, and purging the sampling lines. Sample movement is accomplished through bidirectional TTL actuated operation, with a flow rate of 25 ml/min. (nominal). The 810 Peristaltic Pump is paired with the 8000 Dissolution Sampling Station for automated sample volume accuracy of ± 0.5 ml. The autocalibration block ensures the volume accuracy for each line without regard to changes in the tubing. By timing how long it takes to fill a specific volume, the 8000 can accurately dispense based on the time specific to each line. The 810 Peristaltic Pump comes standard with Marprene tubing with an inside diameter of in. and adjustable pump cartridges. Silicone and Viton tubing and replacement cartridges are also available. The pump may be configured with 6, 8 or 16 channels. The robust and easily maintained 810 Peristaltic Pump: Allows for timepoint frequency as often as every two minutes Supports surfactant media Can be configured with the 8000 Dissolution Sampling Station or Cary 60 UV Dissolution System 810 Peristaltic Pump 80

83 Automated Dissolution Sampling Systems Cartridges for 810 Peristaltic Pump Agilent 810 Peristaltic Pump 810 Peristaltic Pump, 6-channel, 115V Peristaltic Pump, 6-channel, 230V Peristaltic Pump, 8-channel, 115V Peristaltic Pump, 8-channel, 230V Peristaltic Pump, 16-channel, 115V Peristaltic Pump, 16-channel, 230V Peristaltic Replacement Cartridge 810 Peristaltic Pump replacement cartridge Peristaltic Replacement Tubing Purple/white Marprene replacement tubing, 8/pkg Purple/white Viton replacement tubing, 8/pkg White silicone replacement tubing, 8/pkg Colored Teflon Tubing, 50 ft. lengths, for 810 Peristaltic Pump Tubing, colored Teflon, for 3x3, for use with 810 Peristaltic Pump, in. dia., lengths of 50 ft. Tubing, colored Teflon, for 4x2, for use with 810 Peristaltic Pump, in. dia., lengths of 50 ft. Tubing, colored Teflon, for 4x4, for use with 810 Peristaltic Pump, in. dia., lengths of 50 ft. 810 Peristaltic Pump Dimensions Height Width Depth Weight cm / 5.5 in cm / 6 in cm / 18 in. 6.9 kg / 15.2 lb. Sampling Accuracy ± 0.5 ml for 10 ml sample 81

84 Automated Dissolution Sampling Systems Agilent 8020 Dissolution Sampling/HPLC Injector 8020 Dissolution Sampling/HPLC Injector The Agilent 8020 Dissolution Sampling/HPLC Injector provides automated dissolution sampling and HPLC injection for virtually any HPLC system. The dissolution test parameters are controlled via the 8020 base station. Alternatively, the system can be controlled using Dissolution Workstation software. The 8020 can be paired with Agilent s dissolution apparatus, either a 810 Peristaltic Pump, or a 806 Syringe Pump and 808 Filter Changer. Samples are pulled and deposited into empty/capped vials in the collection tray. Injections onto the LC column occur between sampling timepoints. Sample collection always takes precedence over sample injections to ensure sampling accuracy meets pharmacopeial requirements. During a sample point, the injector module goes into standby mode, returning to its task only at the end of the timepoint Instrument Highlights Easily program injection intervals from one to 99 minutes or wait for the ready signal from the LC Configure an injection list to inject standards before, after, or bracketing each group of samples Use as a standalone sample collector, standalone HPLC auto-injector, or both Sample up to 10 timepoints, or 8 timepoints if bracketing of the standard and blank is required The base system is includes a sipper assembly with needle and a fixed, 20 µl injection loop Communication between Auto-Injection station and HPLC is via TTL signal Automate up to four systems with the Dissolution Workstation Software The standard 8020 Dissolution Sampling/HPLC Injector includes: 8020 Dissolution Sampling Station with sipper assembly Autocalibration block for use with 810 Peristaltic Pump (if applicable) Injector module with Rheodyne 7710 valve and fixed 20 µl loop Full Flow Filter starter kit Standard tray for 12 x 32 mm vials Sample pack of 100 capped HPLC vials 82

85 Automated Dissolution Sampling Systems Agilent 8020 Dissolution Sampling/HPLC Injector 8020 Dissolution Sampling Injector for 7000/7010 Dissolution Apparatus 8020, 6-valve, with 810 Peristaltic Pump, 115V , 6-valve, with 810 Peristaltic Pump, 230V , 6-valve, with 806 Syringe Pump, 115V , 6-valve, with 806 Syringe Pump, 230V , 6-valve, with 806 Syringe Pump / 808 Filter Changer, 115V , 6-valve, with 806 Syringe Pump / 808 Filter Changer, 230V , 8-valve, with 810 Peristaltic Pump, 115V , 8-valve, with 810 Peristaltic Pump, 230V , 8-valve, with 806 Syringe Pump, 115V , 8-valve, with 806 Syringe Pump, 230V , 8-valve, with 806 Syringe Pump / 808 Filter Changer, 115V , 8-valve, with 806 Syringe Pump / 808 Filter Changer, 230V Dissolution Sampling Injector for 708-DS and 7025 Dissolution Apparatus 8020, 8-valve, with 810 Peristaltic Pump, 115V , 8-valve, with 810 Peristaltic Pump, 230V , 8-valve, with 806 Syringe Pump, 115V , 8-valve, with 806 Syringe Pump, 230V , 8-valve, with 806 Syringe Pump / 808 Filter Changer, 115V , 8-valve, with 806 Syringe Pump / 808 Filter Changer, 230V , 6-valve, with 810 Peristaltic Pump, 115V , 6-valve, with 810 Peristaltic Pump, 230V , 6-valve, with 806 Syringe Pump, 115V , 6-valve, with 806 Syringe Pump, 230V , 6-valve, with 806 Syringe Pump / 808 Filter Changer, 115V , 6-valve, with 806 Syringe Pump / 808 Filter Changer, 230V Injector 8020 Injection module, 115/230V Note: An 8020 configured with the 806 Syringe Pump requires use of the Dissolution Workstation Software. See page 62 for ordering information Dissolution Sampling Station/HPLC Injector Dimensions Height Width Depth Weight 8020 Dissolution Sampling Station cm / 17.2 in cm / 17 in cm / in kg / 38 lb HPLC Injector cm / 13.5 in cm / in cm / 18 in. 9.4 kg / 20.8 lb 83

86 Automated UV Dissolution Systems UV Dissolution Systems Selecting a UV Dissolution System Agilent offers UV Dissolution Systems with both the 8453 UV-visible Spectrophotometer and the Cary 60 UV-visible Spectrophotometer. Whether you want an online or offline system, multicell based or in situ measurement via fiber optics, we have just the UV-visible system to suit your needs. Online UV Dissolution System Configuration 1. Select the UV spectrophotometer that best suits your testing needs. Some important criteria to take into account: 8453 UV-visible Spectrophotometer The 8453 is a diode array UV spectrophotometer that is ideal for use with multicomponent products. The most economical configuration is equipped with a single flow cell. Samples are pumped to the flow cell by a peristaltic pump and read sequentially. When configured with a single apparatus, the eight-position multi-cell transport (MCT) option withdraws samples simultaneously, pumps the samples to the individual flow cells, reads and returns the samples to the vessels. For even greater flexibility, the MCT option can have up to four apparatus integrated with one UV spectrophotometer. Samples are withdrawn and read sequentially. After measurement, the sample is discarded as opposed to returned to the vessel. Cary 60 UV-visible Spectrophotometer Multicell UV Dissolution: Utilizes a 16-channel multicell changer that allows for the integration of up to two dissolution apparatus with one UV spectrophotometer. In a dualapparatus configuration, each vessel has a dedicated flow cell. Samples are taken simultaneously and read sequentially. Options include a peristaltic pump, syringe pump, or a syringe pump with filter changer. The Cary WinUV software also allows incorporation of the 8000 Dissolution Sampling Station in line with the Cary 60, offering archiving of samples as they are read. Fiber Optic UV Dissolution: May be configured for use with a 12-channel fiber optic multiplexer, and integrated with either one or two apparatus. The fiber optic probes are mounted on the moveable manifold and are only in the media during measurement timepoints. If you need assistance with selecting the system most suitable for your laboratory, please contact your Agilent representative. 2. Once you have determined the UV platform, you will need to determine which apparatus you would like to integrate. Both the 708-DS and 709-DS are fully compatible with these UV systems. In addition, you can retrofit many older Varian and VanKel apparatus with either system. 84

87 Automated UV Dissolution Systems UV Dissolution Selection Chart 8453 and Cary 60 UV-visible Spectrophotometers General Information 8453 Cary 60 Software Package ChemStation Cary WinUV Number of Apparatus 1 to 4 (Valve System) 1 to 2 Multicomponent Analysis Yes No Fiber Optic System Availability No Yes Spectrophotometer Details 8453 Cary 60 Wavelength Range nm nm Slit Width 1 nm 1.5 nm Lamp Type Tungsten and Deuterium Xenon Flash Instrument Design Diode Array Scanning Wavelength Accuracy < ± 0.5 nm < ± 0.5 nm Wavelength Reproducibility < ± 0.02 nm ± 0.1 nm Photometric Accuracy < ± Abs (NIST 930E) ± Abs (NIST 930D) Photometric Noise < Abs ± Abs Baseline Flatness < Abs < Abs Stray Light < 1.0% (198 nm) < 0.05% (220 nm) < 0.03% (340 nm) < 1.0% (198 nm) < 0.05% (220 nm) 0.05% (370 nm) Online Sampling System 8453 Cary 60 Details Closed Loop Sampling Yes (Multicell) Yes (Multicell) Maximum Path Length (mm) 50 (Multicell) 10 (Multicell) 20 (Fiber Optic) Automated Dosage Delivery Yes Yes and Sampling Temperature Monitoring Yes Yes Simultaneous Sampling Yes (Multicell) Yes (Multicell) Sequential Sampling Yes (Valve Systems) Yes (Fiber Optic) Sample Filtration (minimum pore size µm) Sample Archival 5 µm 0.45 µm (with 808 Filter Changer) No Yes (Multicell with 8000 Dissolution Sampling Station) 85

88 Automated UV Dissolution Systems UV-visible Software Details 8453 (ChemStation) Real-time Data Visible Yes Yes Independent Methods Yes Yes Offline Analysis Yes Yes User-definable Dissolution Yes No Result Calculation Tablet Weight Normalization Yes Yes Medium Volume Changes Yes Yes Customizable Reports Yes Yes Apparatus Performance Tracking Yes No 21 CFR Part 11 Package Yes Yes Electronic Signatures Yes Yes Cary 60 (Cary Win UV) Select from either of Agilent's UV-Vis Spectrophotometers for a complete online solution 8453 UV-Vis (left) or Cary 60 (right) 86

89 Automated UV Dissolution Systems Agilent 8453 UV Dissolution Systems Online UV Dissolution Agilent, Varian and VanKel dissolution apparatus can be directly linked to the diode array Agilent 8453 UV-visible spectrophotometer for automated test runs. The UV-visible ChemStation software integrates the apparatus, the spectrophotometer and the computer into a complete system supporting guided operation and unattended test runs with online test progress monitoring. The software supports test preparation, as well as post run activities. The software offers additional features by adding advanced capabilities for method development and validation, as well as a tool set for 21 CFR Part 11 compliance. Online Sampling Systems The ChemStation software controls the sampling and pumping systems, or you can choose to manually operate the systems. The pumps, with convenient cassette-mounted tubing, offer variable speeds for adjustable flow rates, which are reversible as well. The online sampling systems support eight measurement channels depending on the hardware configuration. The measurement cycle at each timepoint is configurable with up to eight measurements consisting of a blank, standard and sample. Disposable in-line filters prevent the transfer of non-dissolved particles into the flow cells. Reversal of the pump direction at the end of a transfer cycle flushes particles from the filters, avoiding clogging. Flow tests before and after completion of a run can be applied ensuring the equipment has performed reliably during the entire run. A large variety of flow cells with different path lengths, from 0.1 to 10 mm, in combination with the variable pump times are ideal for aligning your target UV-visible analysis. You can adapt the various cell volumes, and measure the respective exchange pump time by the flow test included in the ChemStation software. Services for IQ/OQ/PQ are available assuring the proper performance of the entire system. 708-DS Dissolution Apparatus paired with the 8453 UV-visible Spectrophotometer 87

90 Automated UV Dissolution Systems 8453 UV Dissolution System: Multicell-based Sampling The multicell-based system is the most commonly used and versatile sampling system for single apparatus testing, and is ideally suited for QA testing and formulation development. The system uses a multicell transport with eight flow cells, one for the blank, up to six for the individual vessels and one for a standard, with a multi-channel pump to sample all vessels simultaneously. A minimum cycle time of two minutes is possible. The dissolution medium is returned to the vessel so that there is no change in medium volume during the test. The system is capable of taking a large number of data points, allowing for a well characterized dissolution profile. Flow Configuration (as shown below) 1. The sampling manifold is lowered and the pump primes the lines. 2. The sample from each vessel is pulled into the flow cells of the 8453 simultaneously. The manifold rises and the pump is stopped during measurement. 3. After measurement, the pump pushes the samples back to the return cannulas and into the vessels. All media is returned to the individual vessel from which it was drawn. No sample volume is lost in this-closed loop system UV Dissolution System: Multicell-based Sampling 88

91 Automated UV Dissolution Systems 8453 UV Dissolution System: Valve-based Sampling The valve-based system is the most cost-effective UV dissolution solution. The system uses an eight-port valve to switch between blank, control and the six dissolution vessels, with a single channel and cuvette. Because the sampling is sequential, the minimum cycle time is five minutes. The ChemStation software performs calculation correction for the approximate 4 ml waste volume during result processing. Flow Configuration (as shown below) 1. The sampling manifold is lowered, the pump is activated and samples are pulled sequentially through the 8-port valve. 2. The samples are moved to a single flow cell on the 8453 and individually read. 3. From the flow cell, the sample is pulled through the peristaltic pump. 4. Finally, the sample is discarded into a waste receptacle. Once all vessel positions have been sampled and analyzed, the manifold rises until the next timepoint UV Dissolution System: Valve-based Sampling 89

92 Automated UV Dissolution Systems 8453 UV Dissolution System: Multi-apparatus Sampling The Agilent 8453 UV dissolution testing system, in combination with the valve-based, multi-apparatus sampling capabilities, offers increased productivity when running a large number of samples. The system uses a single spectrophotometer to measure a blank, six vessels and a control in up to four apparatus all within five minutes, and each apparatus can run a different method, if needed. The methods and features are identical with the single-apparatus, valve-based system. In both systems the samples are read sequentially. Each apparatus has a dedicated flow cell. Flow Configuration (as shown below) 1. At the appropriate timepoints, the sampling manifolds are lowered and the samples are moved individually to the 8-port valve. 2. One sample from each apparatus is pulled through the valve and placed into the flow cell assigned to that apparatus. The pump stops and the measurement is taken. 3. The samples are then pulled through the peristaltic pump. 4. Finally, the sample volume is discarded into waste. This cycle is then repeated for the next vessel in each apparatus until all the samples have been measured. The sampling manifold is in the lowered position during the sampling process UV Dissolution System: Multi-apparatus Sampling 90

93 Automated UV Dissolution Systems Agilent 8453 UV Dissolution Systems Offline UV Dissolution In the offline approach of UV dissolution testing, the dissolution samples are collected independently of the 8453 UV-visible spectrophotometer. For example, a number of dissolution apparatus can be used in conjunction with an automated sampling system. The samples are then transported to the 8453 for analysis. Sample analysis and data evaluation are performed using the 8453 creating a flexible approach to evaluating dissolution results. It may also be applied for other types of UV analysis. The offline analysis approach is scalable and applies to: Sipper operation is easy with built-in measurement buttons. Manual operation using standard UV cuvettes Sipper operation using a flow cell Autosampler that provides unattended sample introduction of up to 240 samples Software support through ChemStation software is used for introducing samples in the right sequence and is provided with your system. No change to a dissolution method is required, only the manner in which the sample is introduced is changed. In the combination with automated sampling, the use of the XY autosampler offers a significant automation and an optimum utilization of the spectrophotometer UV-Visible Spectrophotometer Dimensions Height Width Depth Weight 18.5 cm / 7.3 in cm / 13.5 in. 56 cm / 22 in kg / 36.3 lbs. 91

94 Automated UV Dissolution Systems UV-Vis ChemStation Software The run-time display shows profiles, actual values and the last spectra, as well as the status of instrument at a glance. The UV-Visible ChemStation software belongs to Agilent s family of ChemStation software for analytical instruments, and its portfolio of features facilitates a strong learning and usability experience. The application module for dissolution testing offers precise and accurate sample analysis combined with online and offline dissolution testing analysis and results evaluation. A ChemStation dissolution testing method is generated independent from the approach of sampling. This offers new opportunities in method transfer even if different approaches in the experimental setup and equipment are applied. A ChemStation dissolution method supports the dissolution workflow from test preparation to the final clean-up and results archival. In its online configuration, the ChemStation dissolution software monitors and checks the apparatus performance during a dissolution testing run. The results file generated after test completion contains all information to verify, reprocess and document the dissolution experiment. The ChemStation s Security Pack provides the necessary 21 CFR Part 11 requirement tools without the need of a database. Electronic signatures can be issued on a results file for various purposes. Apparatus drivers, ChemStation software and the dissolution application module are required to control your dissolution apparatus. Did You Know? ChemStation s dissolution software supports full spectrum acquisition. During a dissolution run, corrections can be applied for capsule absorbance and background scattering. Multicomponent analysis of formulations with multiple active ingredients can also be analyzed. Analytical methods can be optimized without repeating the test run simply by recalculation of the run data. Dissolution with the 8453 UV-visible Spectrophotometer 8453 UV-visible System Agilent 8453 UV-visible value system Agilent 8453 UV-visible pharma system UV-visible ChemStation Dissolution Software Dissolution testing software Dissolution apparatus driver software for Agilent, Varian and VanKel Apparatus 1 and 2 Automated Sipper System for Sampling Systems XY Autosampler Multicell Transport Sampling System Valve Sampling System Multibath sampling system for two dissolution apparatus Additional sampling system for one dissolution apparatus G1812AA G1815AA G1118AA G7900AA 89068D G1811A G1127A G1128A G1129A G1130A 92

95 Automated UV Dissolution Systems 8453 UV Dissolution Systems For the 8453 UV Dissolution Systems, each bundle is fully inclusive of the apparatus, spectrophotometer and required accessories. The 708-DS Dissolution Apparatus is included as standard. The three bundles, which all offer automated runs analyzed by the 8453 UV-visible Spectrophotometer, include: 8453 UV Dissolution System Bundles 8453 UV Dissolution System Value 8453 UV Dissolution System 708-DS Dissolution Apparatus Valve-based sampling system with 8453 UV-visible Spectrophotometer PC and printer UV-visible ChemStation plus Security Pack software Multi-apparatus 8453 UV Dissolution System Two 708-DS Dissolution Apparatus Multi-apparatus sampling system with 8453 UV-visible Spectrophotometer PC and printer UV-visible ChemStation plus Security Pack software Research 8453 Dissolution System 708-DS Dissolution Apparatus Multicell-based sampling system with 8453 UV-visible Spectrophotometer PC and printer UV-visible ChemStation plus Security Pack software 8453 UV Dissolution System Options G7920A G7921A G7922A 8453 UV Dissolution System without printer G792xA# UV Dissolution System without PC and printer G792xA# UV Dissolution System without 708-DS apparatus G792xA#900 Replace 708-DS with 709-DS Dissolution Apparatus G792xA#910 The standard 708-DS Dissolution Apparatus includes: 8 testing positions Sampling manifold AutoTemp 7 1L clear glass vessels and one 200 ml conversion kit The standard 709-DS is identically equipped to the 708-DS, except the 200 ml conversion kit is not available with the 709-DS. Eight 1L clear glass vessels are included instead. Should you require further customization (example: amber vessels, 2L vessels, rotating cylinders, etc.), Agilent can easily custom configure your apparatus. Contact your Agilent representative for details. For a custom dissolution system, you may also create a 708-DS or 709-DS that meets your specific needs and order the individual system components from the table on page

96 Automated UV Dissolution Systems 708-DS/709-DS Ordering 8-position online UV Dissolution Systems (incl. 200 ml conversion kit and vessel for standard position) 708-DS and 709-DS Apparatus for use with 8453 UV-Vis Spectrophotometers 708-DS standalone apparatus without manifold 708-DS with Autosampling only 708-DS with Autosampling and AutoTemp 708-DS with Autosampling, AutoTemp and DDM 709-DS with Autosampling and AutoTemp 709-DS with Autosampling, AutoTemp and DDM 8453 with Single Apparatus Multicell 8453 with Single Apparatus Valve Setup 8453 with Multiapparatus System and Resident Probe Kit and Resident Probe Kit and Resident Probe Kit 2 G1815AA G1815AA G1815AA G1118AA G1118AA G1118AA G7900AA G7900AA G7900AA G1127A G1128A G1129A G1815AA G1815AA G1815AA G1118AA G1118AA G1118AA G7900AA G7900AA G7900AA G1127A G1128A G1129A G1815AA G1815AA G1815AA G1118AA G1118AA G1118AA G7900AA G7900AA G7900AA G1127A G1128A G1129A G1815AA G1815AA G1815AA G1118AA G1118AA G1118AA G7900AA G7900AA G7900AA G1127A G1128A G1129A G1815AA G1815AA G1815AA G1118AA G1118AA G1118AA G7900AA G7900AA G7900AA G1127A G1128A G1129A G1815AA G1815AA G1815AA G1118AA G1118AA G1118AA G7900AA G7900AA G7900AA G1127A G1127A G1129A 3 1 Add paddles, basket shafts, and baskets for 708-DS and 709-DS. See page 16 for ordering information. 2 For resident probe kit part numbers, see page Supports two (2) dissolution apparatus. Add G1130A for each additional apparatus, up to four (4). 94

97 Automated UV Dissolution Systems Agilent Cary 60 UV Dissolution System Online UV Dissolution Multicell Precise and accurate determination of dissolution concentrations is achieved with UV methods. These remain among one of the most common analytical techniques for dissolution sample analysis. Agilent s Online UV Dissolution System with the Cary 60 UV-visible Spectrophotometer integrates dissolution testing with online UV analysis to provide a single-source, automated performance testing solution. Available in either single- or dual-apparatus configurations, the system supports individual flow cells for a range of path lengths, from 0.2 to 10 mm. The multicell changer accommodates eight flow cells per dissolution apparatus, allowing for a blank, standard and six samples. The system can take both blank and standard readings during each timepoint. Additionally, each vessel position is configured with its own flow cell and tubing, eliminating cross-contamination. Cary 60 UV Dissolution System: Single Apparatus with 810 Peristaltic Pump The Cary 60 can be configured with a peristaltic pump to transfer the sample to the flow cell. Cells are analyzed and the sample is returned to the vessel maintaining vessel volume and eliminating the need for media replacement. Should you wish to retain a sample, the 8000 Dissolution Sampling System can be used in conjunction with the spectrophotometer. The sample will be read and a portion retained for failure investigation if needed. Flow Configuration (as shown below) 1. At each timepoint, the sampling manifold lowers and the blank, standard and samples are transferred to the peristaltic pump simultaneously. 2. The pump then moves the sample into individual flow cells contained in the cell changer of the Cary 60. The manifold rises. 3. After the samples are measured, the pump reverses flow and returns all sample volume to the dissolution vessels. No volume is lost in this closed-loop system. The sample lines remain empty until the next timepoint. sampling cannula Before Sampling After 1 2 return 3 cannula Prime Sampling 1 2 Purge 3 Prime Read Purge Cary 60 UV Dissolution System Single Apparatus Setup with 810 Peristaltic Pump 95

98 Automated UV Dissolution Systems Cary 60 UV Dissolution System: Single Apparatus with 806 Syringe Pump, 808 Filter Changer and 8000 Sampling Station The multicell system is ideal for providing repeatable results, especially when 0.45 µm filtering or sample archival is required, via the 808 Filter Changer and 8000 Dissolution Sampling Station. Integrating the 8000 with the Cary 60 allows you the flexibility of online UV analysis and offline collection for those methods requiring an LC finish. Flow Configuration (as shown below) 1. At each timepoint, the sampling manifold lowers and the blank, standard and samples are transferred to the 806 Syringe Pump simultaneously. 2. The pump then moves the sample through the filters of the 808 Filter Changer. 3. As the volume moves to the 8000 Dissolution Sampling Station, the samples are collected for archival. 4. The volume continues on into individual flow cells contained in the cell changer of the Cary 60. The manifold rises. 5. After the samples are measured, the sample lines are purged with air and all volume is returned to the dissolution vessels. No volume is lost in this closed-loop system and the sample lines remain empty until the next timepoint. Prime Sampling Purge sampling cannula Before 1 Sampling 2 return cannula After 3 full flow filter Cary 60 UV Dissolution System Single Apparatus Setup with 806 Syringe Pump, 808 Filter Changer and 8000 Dissolution Sampling Station 96

99 Automated UV Dissolution Systems Cary 60 UV Dissolution System: Dual Apparatus with 810 Peristaltic Pumps For maximum efficiency, up to two dissolution apparatus can be used with a single Cary 60. A dual apparatus system will incorporate two pumps to allow independent methods to be run on the two systems. A dual system may include any combination of dissolution apparatus and sampling equipment including the 810 Peristaltic Pump, 806 Syringe Pump, 808 Filter Changer and 8000 Sampling Station. Flow Configuration (as shown below) 1. At each timepoint, the sampling manifold lowers and the blank, standard and samples are transferred to the 810 Peristaltic Pump simultaneously. 2. The pump then moves the sample into individual flow cells contained in the cell changer of the Cary 60. The manifold rises. 3. After the samples are measured, the pump reverses flow and returns all sample volume to the dissolution vessels. No volume is lost in this closed-loop system. The sample lines remain empty until the next timepoint. The flow configuration is identical for each apparatus in a dual-system setup. Independent methods can be executed concurrently. The cell changer of the Cary 60 has the capacity to support two sets of dedicated flow cells, eliminating the chance of cross-contamination or carryover. sampling cannula Before 1 full flow filter Sampling After 2 return 3 cannula Prime 1 Sampling 2 Purge 3 Prime Read Purge Cary 60 UV Dissolution System Dual Apparatus Setup with 810 Peristaltic Pumps 97

100 Automated UV Dissolution Systems Agilent Cary 60 UV-Vis Spectrophotometer Online UV Dissolution Fiber Optic Cary 60 UV-visible Spectrophotometer with multiplexer for fiber optic UV dissolution The Fiber Optic Online UV Dissolution System offers versatility and flexibility while delivering the highest level of automation and data integration for your UV dissolution needs. The Cary 60 UV-visible spectrophotometer offers excellent optical transmission and reproducibility capabilities, and the extended linear photometric range is ideally suited for superior fiber optic analysis. The fiber optic multiplexer ensures precise and rapid position-to-position movement to decrease time needed between sample timepoints. The system s probes use silica fibers for optimal performance, and interchangeable tips make cleaning and replacement easy. Replaceable tips require less investment versus other fiber optic systems. Rather than purchase a set of new fiber optic probes, simply change your tip to the needed pathlength. Tip pathlengths from 1 to 20 mm are available to accommodate a wide variety of sample concentrations. Why Choose Fiber Optic UV Dissolution? Save time with real-time sample analysis and reporting of dissolution data using in situ fiber optic probes. Also, no pumps or moving media/samples means no system flush is required. This greatly improves turnaround time and maximizes efficiency simply rinse and you're ready to begin the next test. Advantages of Fiber Optic UV Dissolution Ideal for rapid timepoint requirements with the ability to take readings as often as every 45 seconds Samples are read directly in the dissolution vessel, which eliminates contamination, carryover and dilution of samples Compensates for samples with excipient and background interferences Cleaning is simple, requiring only rinsing and wiping of the fiber optic probes and tips Fewer moving parts and consumables reduce cost of ownership The system is based on the Cary 60 UV-visible Spectrophotometer, with Xenon flash lamp technology for fiber optic utilization. Because the system is based on a standard spectrophotometer, parts and service are readily available worldwide. The fiber optic system utilizes a 12-position multiplexer, to read samples sequentially. A single spectrophotometer can be used with two dissolution apparatus. The fiber optic probes can be mounted on a movable manifold that lowers the probe to the correct sampling height in the vessel. The sample is read and the probe is raised either entirely out of the media or held in the upper level of the media to minimize bubble formation and prevent drying on the tip surface. Cary 60 UV-Vis Spectrophotometer Dimensions Height Width Depth Weight 19.6 cm / 8 in cm / 19 in cm / 23 in. 18 kg / 40 lb Cary 60 UV-Vis Spectrophotometer Specifications Wavelength Range Wavelength Accuracy Wavelength Reproducibility Photometric Range UV-Vis limiting Resolution nm ± 0.5 at nm ± 0.1 nm ± 3.3 Abs 1.5 nm 98

101 Automated UV Dissolution Systems Testing in a Regulated Environment? The Cary WinUV Dissolution Software includes an optional Compliance Manager package that allows your laboratory to install and configure proper 21 CFR Part 11 controls. Did You Know? When the Cary 60 is not being used for an online Dissolution test, there is an entire suite of applications available in the Cary WinUV software to maximize its value as a standalone spectrophotometer. These include Advanced Reads, Scan, Concentration, Kinetics, and more. Cary WinUV Dissolution Software The Cary WinUV Dissolution Software supports both Agilent s Multicell and Fiber Optic Online UV Dissolution Systems. The software generates accurate and robust data and accommodates a wide variety of dissolution samples and methods. Analysts can easily customize final reports with a complete summary of the data acquisition using comparison and statistical evaluation tools, data tables and dissolution profiles. Agilent Cary 60 UV-Vis Spectrophotometer The Cary 60 utilizes a Xenon flash lamp that only turns on when acquiring a data point, minimizing photo-bleaching of samples. The Cary 60 acquires data at a rate of 80 Hz with a maximum scan rate of 24,000 nm/min applying a dual-detector approach to measure sample and source simultaneously. This rugged instrument is easy to operate and economical to own. Because the lamp only illuminates when taking a reading, not only do you save energy, but there are significant lamp savings versus conventional deuterium lamp systems. Cary WinUV Dissolution Software Can integrate a peristaltic pump, or syringe pump, filter changer and autosampler for accurate preparation of samples and archival Controls apparatus features such as dosage delivery, automated sampling and vessel temperature monitoring Creates data processing and reports for samples taken offline using the UV dissolution manual program Accommodates media change methods, capsule shell corrections and infinity spins required for various methods Includes advanced UV capabilities, such as second derivative analysis, baseline correction and more, to work with challenging spectra Meets requirements for 21 CFR Part 11 compliance Progression of a UV Dissolution profile as data is acquired 99

102 Automated UV Dissolution Systems Flexible Standard Measurement and Calculation Options The UV Dissolution application incorporates several online standard options including Post Cycle Standard (for bracketed analysis), Bridged Mean, and Running Mean. Each method stores how results are calculated depending on your specific preferences. Superior Linear Range (3 Abs) of the Agilent Cary 60 UVvisible Spectrophotometer The linear range of a spectrophotometer defines the absorbance range in which measurements are accurate. The linear range of the Cary 60 permits the analysis of a wide range of sample concentrations, reduces the need for dilution or smaller path length cells, and measures highly turbid solutions (for fiber optics). Key Software Functionalities Advanced UV-Vis analysis options include single wavelength, scan, and single and scan options Allows two independent methods to be run simultaneously when using a dual-apparatus configuration Online or offline testing of standards for percentage (%) and milligrams (mg) dissolved calculations Built-in PreTest Scan feature to confirm analysis wavelength prior to dosage introduction Immediate notification of out-of-specification results Supports media change or media addition methods Hardware configuration files and method files stored separately for quick retrieval and reduced turnaround times Dissolution profiles and customizable reports are available in real time Manual data entry and recalculation provides flexibility by allowing you to obtain validated calculations and reports for samples taken on other offline systems Diagnostics module allows for easy troubleshooting and cleaning A comprehensive Method Setup utility is at the core of Cary WinUV Dissolution Software 100

103 Automated UV Dissolution Systems Dual-cell Tubing Kit The Cary 60 makes it easy to interconnect two different cells within the 16-position multicell transport. This allows you to switch between two sets of cells, typically with different path lengths, with no disassembling or reassembling of the tubing lines. Switching between methods requiring cells of different path lengths is as easy as selecting the cells to be read using the Cary WinUV Dissolution Software. Only one dissolution apparatus can be used when the dual cell tubing is in place. Agilent s UV dissolution systems are scalable to your needs. In the ordering tables, you will find all components forming a complete dissolution testing system with UV-Visible analysis. The system consists of one of the UV-Visible systems, the software, and one or more sampling systems. See page 104 for the dissolution apparatus required for the system. Automated UV Systems Cary WinUV Dissolution Software and Accessories Cary WinUV Software UV Dissolution Multicell Packages and Software Cary WinUV Software package, for multicell UV dissolution, includes PC, software and Cary 60 spectrophotometer with multicell changer Cary WinUV Software package, for multicell UV dissolution, without PC, includes software and Cary 60 spectrophotometer with multicell changer Cary WinUV Software, for multicell UV dissolution, version Cary WinUV Software UV Dissolution Multicell Accessories / Upgrades Benchtop table for UV dissolution system, with keyboard tray Cary 50/60 upgrade kit, includes software, 18-cell holder Flow cell for use with Cary 50/60, 10 mm Flow cell for use with Cary 50/60, 0.2 mm Flow cell for use with Cary 50/60, 0.5 mm Flow cell for use with Cary 50/60, 5 mm Flow cell for use with Cary 50/60, 2 mm (required for multicell changer upgrade) Flow cell for use with Cary 50/60, 1 mm Cary 50 extended sample compartment Cary 50 tubing coupler Cary 50/60 18-cell holder Cary 50 PCI card and cable Tubing kit, dual path length, for Cary UV Dissolution system Tubing replacement kit, for Cary UV Dissolution System, Tubing replacement kit, for Cary UV Dissolution System, Cary WinUV Software UV Dissolution Fiber Optic Packages and Software Cary WinUV Software package, for fiber optic UV dissolution, includes PC, software and Cary 60 spectrophotometer with multiplexer Cary WinUV Software package, for fiber optic UV dissolution, without PC, includes software and Cary 60 spectrophotometer with multiplexer Cary WinUV Software, for fiber optic dissolution, version (Continued) 101

104 Automated UV Dissolution Systems Upgrade Your Cary 50/60 Select the appropriate upgrade option based on the model of dissolution apparatus to transform your spectrophotometer into an online UV dissolution system. The options include the necessary software, cell changer or multiplexer, and other accessories. Fiber optic probes/tips and flow cells must be ordered separately depending on the desired pathlength. Automated UV Systems Cary WinUV Dissolution Software and Accessories Cary WinUV Software UV Dissolution Fiber Optic Accessories / Upgrades Benchtop table for UV dissolution system, with keyboard tray Fiber optic multiplexer software on CD port USB-to-serial converter External cuvette holder, 1 cm, for FO External cuvette holder cover, 1 cm Fiber optic patchcord, 20 in Fiber optic probe, 2 m, no tip, for 7000, 7010, 708-DS, 709-DS Fiber optic probe, 2 m, no tip, 7025/ Fiber optic removable tip, 1 mm Fiber optic removable tip, 2 mm Fiber optic removable tip, 5 mm Fiber optic removable tip, 10 mm Fiber optic removable tip, 20 mm Fiber optic removable tip, 4 mm Fiber optic probe holder, for Distek evaporation cover Cary 50/60 Upgrade Options Cary 50 fiber optic upgrade, includes Cary WinUV software for fiber optic UV dissolution and multiplexer, for 7025 Cary 50 fiber optic upgrade, includes Cary WinUV software for fiber optic UV dissolution and multiplexer, for 7010 Cary 50 fiber optic upgrade, includes Cary WinUV software for fiber optic UV dissolution and multiplexer, for 7000 Cary 50 fiber optic upgrade, includes Cary WinUV software for fiber optic UV dissolution and multiplexer, for 708-DS Cary 60 fiber optic upgrade, includes Cary WinUV software for fiber optic UV dissolution and multiplexer, for 7000 Cary 60 fiber optic upgrade, includes Cary WinUV software for fiber optic UV dissolution and multiplexer, for 7010 Cary 60 fiber optic upgrade, includes Cary WinUV software for fiber optic UV dissolution and multiplexer, for 7025 Cary 60 fiber optic upgrade, includes Cary WinUV software for fiber optic UV dissolution and multiplexer, for 708-DS 102

105 Automated UV Dissolution Systems Cary 60 integrates easily with single- or dual-apparatus operation for increased throughput and automation Long-lasting, no warm-up time Xenon lamp flashes only when taking a measurement No degradation of photosensitive active drug components associated with continually burning lamps Virtual immunity to room light, reducing noise and allowing for a linear absorbance range up to 3.3 AU Configurable with Agilent 8000 for collecting and archiving samples for LC analysis (multicell only). See the following example of a 708-DS with 6 positions, set up for paddles, DDM option, AutoTemp option, Fiber Optic UV, PC, and a 5 mm pathlength. 708-DS and Fiber Optic UV Dissolution System Ordering Example Quantity DS system, DDM, sampling, and temperature, 6-position Cary WinUV Software package, for fiber optic UV dissolution, includes PC, software and Cary 60 spectrophotometer with multiplexer Paddle, lower interchangeable, electropolished stainless steel Fiber optic probe, 2 m, no tip Fiber optic removable tip, 5 mm Cary 60 Fiber Optic UV Dissolution System 103

106 Automated UV Dissolution Systems Cary 60 UV Dissolution Systems To simplify the selection process with the Cary 60 UV-visible Spectrophotometer, and 708-DS or 709-DS Dissolution Apparatus, refer to the following ordering table. All of these systems include 1L clear glass vessels, a standard 200 ml conversion kit ( (muliticell only), a sampling manifold, tubing and connectors. Select the appropriate numbers for your UV Dissolution System bundle and then add the desired paddles or basket, shafts and flow cells. 708-DS/709-DS Ordering 8-position online UV Dissolution Systems (incl. 200 ml conversion kit and vessel for standard position) 708-DS and 709-DS Apparatus for use with Cary 60 Dissolution Systems Cary 60 with 810 Peristaltic Pump Cary 60 with 806 Syringe Pump Cary 60 with 806 Syringe Pump and 808 Filter Changer 708-DS standalone apparatus without manifold and Resident Probe Kit and Resident Probe Kit and Resident Probe Kit (115V) or (230V) (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (115V) or (230V) N/A N/A (with PC) or (no PC) N/A N/A , DS with Autosampling only (115V) or (230V) (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (115V) or (230V) N/A N/A (with PC) or (no PC) N/A N/A , DS with Autosampling and AutoTemp (115V) or (230V) (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (115V) or (230V) N/A N/A (with PC) or (no PC) N/A N/A , DS with Autosampling, AutoTemp and DDM (115V) or (230V) (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (115V) or (230V) N/A N/A (with PC) or (no PC) N/A N/A , DS with Autosampling and AutoTemp (115V) or (230V) (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (115V) or (230V) N/A N/A (with PC) or (no PC) N/A N/A , DS with Autosampling, AutoTemp and DDM (115V) or (230V) (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (115V) or (230V) N/A N/A (with PC) or (no PC) N/A N/A , Add paddles, basket shafts, and baskets for 708-DS and 709-DS. See page 16 for ordering information. 2 For resident probe kit part numbers, see page Add appropriate accessory kit for 8000 Dissolution Sampling Station. See page 72 for ordering information. 4 Flow cells or fiber optic probes/tips not included. See page for ordering information

107 Automated UV Dissolution Systems Cary 60 with 806 Syringe Pump and 8000 Dissolution Sampling Station Cary 60 with 806 Syringe Pump, 808 Filter Changer and 8000 Dissolution Sampling Station Cary 60 UV-visible Spectrophotometer for Fiber Optic UV Analysis and Resident Probe Kit and Resident Probe Kit 2 N/A (115V) or (230V) (115V) or (230V) N/A (with PC) or (no PC) (with PC) or (no PC) N/A N/A , N/A N/A N/A (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (with PC) or (no PC) N/A , N/A N/A (with PC) or (no PC) (115V) or (230V) N/A (with PC) or (no PC) (with PC) or (no PC) N/A , N/A N/A (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (with PC) or (no PC) N/A , N/A N/A (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (with PC) or (no PC) N/A , N/A (115V) or (230V) (115V) or (230V) (with PC) or (no PC) (with PC) or (no PC) (with PC) or (no PC) N/A , N/A Cary 60 with 810 Peristaltic Pump and 8000 Dissolution Sampling Station and Resident Probe Kit (115V) or (230V) (with PC) or (no PC) N/A N/A (115V) or (230V) (with PC) or (no PC) N/A N/A (115V) or (230V) (with PC) or (no PC) N/A N/A (115V) or (230V) (with PC) or (no PC) N/A N/A (115V) or (230V) (with PC) or (no PC) N/A N/A (115V) or (230V) (with PC) or (no PC) N/A N/A 105

108 Automated HPLC Systems Agilent HPLC Solutions A complete portfolio of scalable HPLC and UHPLC solutions for dissolution analysis. For utmost flexibility Agilent has created a continuum of products from compact instruments for routine LC to ultrahigh performance LC/MS systems. Choose the best configuration to optimize every part of your laboratory operations and be assured that each system can be enhanced as required to meet future challenges. Regardless of your workflow, we have a solution to your method. We offer offline analysis through a segmented collection and filtration (down to 0.45 µm), as well as online analysis with the collection and filtration followed by direct injection. Additionally, our systems provide archival of samples in the event a failure investigation is required. Agilent 1290 Infinity LC System Infinitely more powerful The Agilent 1290 Infinity LC is the last word in chromatographic performance providing highest speed, resolution and sensitivity. Wide power range up to 1200 bar deploy any particle type, any column dimensions, or any mobile and stationary phases For seamless instrument-to-instrument method transfer, simply emulate other LC systems with Agilent's new ISET Intelligent System Emulation Technology Lower total cost of ownership get UHPLC productivity at service costs comparable to HPLC equipment quality Agilent 1290 Infinity LC System Agilent 1260 Infinity LC System Infinitely more confident The Agilent 1260 Infinity LC raises the standard in HPLC without raising the price. It offers new levels of productivity, data quality and robustness to give you highest confidence in your investment. 600 bar standard pump pressure, 80 Hz standard detector speed and up to 10 times higher UV detection sensitivity be prepared for today s and tomorrow s challenges 100% compatible with all your HPLC methods ensuring riskless replacement of existing equipment Priced similar to earlier 1200 Series HPLC and markedly below 1200 Series RRLC systems get enhanced UHPLC capability for HPLC price Available for isocratic, binary or quaternary solvent delivery configure a system that exactly matches your needs for chromatographic performance and flexibility Agilent 1260 Infinity LC System 106

109 Automated HPLC Systems Agilent 1220 Infinity LC System Infinitely more affordable The Agilent 1220 Infinity LC is a high quality, integrated system for routine HPLC and advanced UHPLC analysis, for maximum return on investment. 600 bar power range up to 5 ml/min and 80 Hz detector speed prepare your lab to take advantage of latest advances in LC column technology Full compatibility with all other detectors within the 1200 Infinity Series and with 6100 Series Quadrupole MS run any existing HPLC or UHPLC method Uses same technology and parts as 1260 and 1290 Infinity LC systems Agilent 1220 Infinity LC System Integrating Dissolution Apparatus with Other Analytical Instruments Of course our first priority is integrating Agilent dissolution apparatus with Agilent analytical instruments and software. Having one source of dissolution equipment, analytical instrumentation and software ensures you receive the best service and support. We also realize that there are many other brands of equipment, so Agilent offers solutions to give you the choice of which tools work best for you. Agilent dissolution equipment has many features not found on other dissolution equipment. ChemStation and WinUV software take full advantage of these productivity enhancing tools. However, this does not limit you to using other analytical systems with our dissolution apparatus. If you are interested in integrating an existing HPLC system to an Agilent dissolution apparatus, this can be accomplished with the 8020 Dissolution Sampling/HPLC Injector. This system will integrate with most any HPLC through a simple contact closure. Samples are pulled from the dissolution apparatus and stored in a sealed vial, and sample injections are made between timepoints. For more information on the integration of Agilent dissolution equipment with other analytical instruments, contact your Agilent representative. Agilent 8020 Dissolution Sampling/HPLC Injector 107

110 Physical Testers Agilent 100 Automated Disintegration Apparatus, 3-basket model Agilent 100 Automated Disintegration Apparatus and Accessories Integrated disintegration testing that conforms to harmonized regulatory requirements An integral prerequisite for dissolution, dosage forms must be tested for disintegration to ensure maximum active pharmaceutical ingredient (API) contact with media and subsequent bioavailability. The disintegration test is an important quality control process that helps ensure the proper manufacturing controls are in place. The fully programmable Agilent 100 Automated Disintegration Apparatus provides a reliable, compliant approach to disintegration testing. The reciprocating drive system, water bath, and heater/circulator are incorporated into a single instrument offering a compact design to save valuable bench space. The apparatus is available in single- or three-basket models and comes complete with accessories required to perform the standard USP disintegration test. The easy-to-use numeric keypad includes program, temperature, and printer control options. Simply enter the time duration of the test and the baskets will be lifted from the beaker at the end of the run. The basket is held above the media until you return to inspect the results. The 3-basket model provides individual digital time displays for each basket, and tests can be run simultaneously or sequentially, maximizing laboratory efficiency. The optional printer can be added to document critical test information. The standard 100 Automated Disintegration Apparatus comes with: 6-tube basket(s), 10-mesh / 1905 µm (USP) Fluted disks USP Disintegration beaker(s) USP Disintegration spacer gauge 25 mm 108

111 Physical Testers Verified Disintegration Accessories Many standard disintegration accessories, such as the basket rack assemblies, can be ordered with individual certificates that verify conformance of critical dimensions. The certificates include the measurements, measuring device information, and its traceability. Any part number that ends in V indicates a Verified component. 100 Automated Disintegration Apparatus 100 Automated Disintegration Apparatus, single basket, 115V (USP) Automated Disintegration Apparatus, single basket, 230V (USP) Automated Disintegration Apparatus, three-basket, 115V (USP) Automated Disintegration Apparatus, three-basket, 230V (USP) Automated Disintegration Apparatus Baskets Basket, 6-tube, 10-mesh, 1905 µm (USP) Basket, 6-tube, 10-mesh, 1905 µm (USP), verified with certificate V Basket, 6-tube, 20-mesh, 864 µm Basket, 6-tube, 10-mesh, 1905 µm, Nylon, stainless steel screen Basket, 3-tube, 10-mesh, 1905 µm, 38 mm outer dia., Basket, 3-tube, 10-mesh, 1905 µm, 38 mm outer dia., verified with certificate V Basket, 1-tube, 10-mesh, 1905 µm, 44 mm outer dia Basket, 6-tube, 40-mesh, 381 µm, with screened cover Standard Disintegration Apparatus Baskets Basket, 6-tube, 10-mesh, 1905 µm, USP Basket, 6-tube, 10-mesh, 1905 µm, USP, verified with certificate V Basket, 6-tube, 20-mesh, 864 µm Basket, 6-tube, 10-mesh, 1905 µm, Nylon, stainless steel screen Basket, 6-tube, 10-mesh, 1905 µm, Plexiglass, stainless steel screen Basket, 3-tube, 10-mesh, 1905 µm, 38 mm outer dia Basket, 1-tube, 10-mesh, 1905 µm, 44 mm outer dia Basket, 6-tube, 40-mesh, 381 µm, with screened cover Basket, suppository dosages Agilent 100 accessories: (top row, left to right) 6-tube standard, 10-mesh basket; 3-tube, 10-mesh basket; 1-tube, 10-mesh basket; and 6-tube, 40-mesh basket; (bottom row, left to right) standard screen with fluted disks; 3-basket screen with screws; plunger; and 6-tube screen 109

112 Physical Testers 1L disintegration beaker 100 Automated and Standard Disintegration Apparatus Accessories Suspension rod dia. for holding 1-basket rack Cover, for 6-tube, 10-mesh, 1905 µm basket Cover, for 3-tube, 10-mesh, 1905 µm basket Cover, for 6-tube, 40-mesh, 381 µm basket Screen, 10-mesh, 1905 µm, stainless steel, for 6-tube basket, set of Screen, 20-mesh, 864 µm, stainless steel, for 6-tube basket, set of Screen, 40-mesh, 381 µm, stainless steel, for 6-tube basket, set of USP fluted disks, for Agilent 100 and Standard Disintegration Apparatus USP fluted disks, for Agilent 100 and Standard Disintegration Apparatus, V verified with certificate 3 Plastic disks, for Agilent 100 and Standard Disintegration Apparatus Plastic disk, for Agilent 100 and Standard Disintegration Apparatus tube plunger assembly tube plunger assembly tube plunger assembly, for use in Canada Replacement tubes, 6-tube basket, 25 mm, set of Replacement tubes, 6-tube basket, 25 mm, set of 6, verified with certificate V Replacement tubes, 3-tube basket, 38 mm, set of Replacement tube, 1-tube basket, 44 mm Disintegration beaker, for Standard Disintegration Apparatus Disintegration beaker, USP 9th supplement, for Agilent 100 and Standard Disintegration Apparatus Disintegration beaker, USP 9th supplement, for Agilent 100 and Standard V Disintegration Apparatus, verified with certificate Water bath, molded with frame, for 6-basket system, Standard Disintegration Apparatus Water bath, molded with frame, for 1- and 3-basket systems, Standard Disintegration Apparatus Disintegration gauge, 2.5 cm, from vessel bottom Water bath temperature probe

113 Physical Testers Instant Status Reporting By outfitting the 100 Automated Disintegration Apparatus with the optional printer, you have the ability to record instrument status at a predefined interval as well as at any time during the test by pressing Print on the instrument panel. 100 Automated Disintegration Printer Options Retrofit printer option, for Agilent 100, pre-ce marking, 115V Retrofit printer option, for Agilent 100, pre-ce marking, 230V Printer option (or retrofit), for Agilent 100, CE marking, 115/230V Automated Disintegration Apparatus Dimensions Height Width Depth Weight cm / 29.5 in cm / 22 in cm / 20.5 in kg / 65.5 lbs, dry with 3 baskets 100 Automated Disintegration Apparatus Specifications Dip Speed (DPM) Stroke Length (cm) Temperature Range ( C) 30 ± ± 0.1 Ambient + 5 to 55 Temperature Accuracy ( C) Test Duration (hh:mm:ss) ± 0.2 Each position is programmable up to 99:59:

114 Physical Testers Agilent 200 Tablet Hardness Tester and Accessories Compact, rugged instrument for precise hardness testing on a variety of tablet shapes and sizes The 200 Tablet Hardness Tester provides accurate testing of tablet hardness in a smallfootprint apparatus. This economical solution contains an easy-to-use top-loading design for quick, convenient and repeatable measurements. Test tablet hardness up to 35 or 50 kiloponds (kp) using a variety of jaw plates that adapt to almost any size or shape tablet. Agilent 200 Tablet Hardness Tester Tablet thickness and diameter can also be measured using the optional digital gauge. Results are documented, complete with a statistical summary, by using the optional standalone printer. The calibration of the 200 Tablet Hardness Tester is a straightforward procedure that can be completed within minutes using a series of slotted weights and adjustment tools, which are sold separately. Compact, durable design minimizing laboratory/production space required Easily interchangeable jaw plates to accommodate a variety of tablet shapes and sizes Precise tablet hardness measurements achieved up to 50 kiloponds Convenient thickness and diameter option provides additional data acquired in seconds Results summarized in a variety of units including kilopond (kp), Strong-Cobb (SC), or Newton (N) The standard 200 Tablet Hardness Tester comes with: Standard jaw plate Tablet fragment shield Tablet fragment brush Trim pot tool (used during calibration) Calibration weight hanger 112

115 Physical Testers 200 Tablet Hardness Tester 200 Tablet Hardness Tester, 115V, kp/sc Tablet Hardness Tester, 115V, kp/n Tablet Hardness Tester, 115V, SC/N Tablet Hardness Tester, 115V, kp/sc, with thickness/diameter gauge Tablet Hardness Tester, 230V, kp/sc Tablet Hardness Tester, 230V, kp/n Tablet Hardness Tester, 230V, SC/N Tablet Hardness Tester, 230V, kp/sc, with thickness/diameter gauge Tablet Hardness Tester, 115V, kp/sc, 50 kp Tablet Hardness Tester, 230V, kp/sc, 50 kp Periodically Verify Performance with Ease Ensure your 200 Tablet Hardness Tester is performing as expected. Using the calibration weight hanger and adjustment tools with a slotted calibration weight, you can easily calibrate your instrument within minutes. 200 Tablet Hardness Tester Calibration Tools Calibration fixture Trim pot tool Hardness/calibration weight hanger Calibration weight, 200 gm, with certificate Calibration weight, 500 gm, with certificate Calibration weight, 1kg, with certificate Calibration weight, 2 kg, with certificate Calibration weight, 5 kg, with certificate Calibration weight, 10 kg, with certificate Calibration weight, 20 kg, with certificate C B D A. Calibration weight hanger B. Slotted calibration weight C. Tablet tray D. Tablet fragment shield E. Trim pot tool F. Tablet fragment brush A E F 113

116 Physical Testers 200 Tablet Hardness Tester Jaw Plates Jaw plate, standard Jaw plate, shelf type Jaw plate, 1/8 x 60 degree Jaw plate, 1/16 radius Jaw plate, 1/4 radius Jaw plate, 1/8 radius Jaw plate, bolus type Jaw plate, 3/16 radius Jaw plate, flat face Jaw plate, adjustable Tablet Hardness Tester and Accessories Hardness/fragment safety shield Hardness/fragment brush Tablet thickness gauge, handheld, dial gauge, 0-10 mm Tablet thickness gauge, handheld, digital gauge, 0-10 mm RS232 serial port, retrofit Thickness gauge option Thickness gauge retrofit option Battery for Mitutoyo gauge Jaw plates (top row, L to R) standard, 1/8x60 degree, 1/8 radius, flat face (bottom row, L to R) shelf, 1/16 radius, bolus, adjustable 114

117 Physical Testers Automate Documentation and Statistical Analysis of Results The inclusion of the optional compliant printer allows for hardcopy documentation of all testing results. The printout includes a time/date stamp, individual tablet results, and a statistical breakdown that consists of: total number of tablets tested, high, low, range, mean, standard deviation, and % relative standard deviation. 200 Tablet Hardness Tester Printer Options Printer, 115V/230V Printer, retrofit, 115V/230V Printer, 50 kp, retrofit, 115V/230V Printer, kp/n, retrofit, 115V/230V Printer, SC/N, retrofit, 115V/230V Force Conversion Chart 1 kilopond = Newton 1 pound = kilopond 1 kilopond = pound 1 StrongCobb = kilopond 200 Tablet Hardness Tester Dimensions Height (with Height (without thickness gauge) thickness gauge) Depth Width Weight 28 cm / 11 in. 28 cm / 11 in cm / 7.0 in cm/ 11 in. 6.1 kg / 13.5 lbs 200 Tablet Hardness Tester Specifications Range 0.4 to 35 kiloponds (up to 50 kp available) Thickness (with optional thickness gauge) Resolution of 0.01 mm / in. Minimum Tablet Diameter cm / in. with shelf type jaw plate Maximum Tablet Diameter cm / in. Accuracy cm / in. with shelf type jaw plate 115

118 Physical Testers Agilent 250 Friability Tester and Accessories Efficiently replicate environmental factors for compressed tablets Agilent 250 Friability Tester with one dual-chamber drum The Agilent 250 Friability Tester simulates the rigorous environment that compressed tablets withstand during manufacturing, packaging and distribution. Tablets are placed into a drum and subjected to clockwise and/or counterclockwise rotations to replicate the possible edging, crumbling, chipping or breakup that can occur. Designed to meet current USP specifications, the tester is available in either a single- or dualdrum configurations. The unit can be preprogrammed for a specific time period for testing or for a set number of rotations. The initial tablet weight can be stored to easily calculate the actual percent weight loss. As the 250 Friability Tester runs, elapsed time and revolution counts will display depending on the chosen method. Test two batches using the single-chamber, dual-drum model, or up to four different batches simultaneously with the dual-chamber, dual-drum model for greater productivity. Rugged, durable and compact design endures continuous daily usage and easily fits into small laboratory or production areas. Three drum options include the single-chamber drum, the dual-chamber drum and the abrasion drum. For increased accuracy, verified single- and dual-chamber drums are available. Verified Accessories are individually measured for conformance and include a certificate with actual measured values of each drum with ID numbers for traceability. For large or non-circular tablets, a 10-degree lift, or wedge, can be used to prevent irregular tumbling or binding. Note: Initial and final weights should be measured using an analytical balance. Standard 250 Friability Testers include either one or two clockwise-rotating drums, depending on your configuration. The abrasion drum, which rotates both clockwise and counterclockwise, as well as single- and dual-chamber counterclockwise-rotating drums are available. An optional printer can be factory-installed or retrofitted at a later date

119 Physical Testers 250 Friability Testers 250 Friability Tester, 1 dual-chamber drum, 115V Friability Tester, 1 single-chamber drum, 115V Friability Tester, 1 dual-chamber drum, 230V Friability Tester, 1 single-chamber drum, 230V Friability Tester, 2 dual-chamber drums, 115V Friability Tester, 2 single-chamber drums, 115V Friability Tester, 2 dual-chamber drums, 230V Friability Tester, 2 single-chamber drums, 230V Friability Tester, 2 single-chamber drums, 230V/60Hz Friability Tester Printer Options Printer, 115V/230V Printer, 115V/230V, retrofit Agilent 250 Friability Tester, single-drum configuration 117

120 Physical Testers 250 Friability Tester Accessories Dual-chamber drum, clockwise rotation Dual-chamber drum, clockwise rotation, with certificate V Dual-chamber drum, counterclockwise rotation Dual-chamber drum, counterclockwise rotation, with certificate V Single-chamber drum, clockwise rotation Single-chamber drum, clockwise rotation, with certificate V Single-chamber drum, counterclockwise rotation Single-chamber drum, counterclockwise rotation, with certificate V Abrasion drum degree lift (wedge) Printer, 115V/230V Friability Tester Dimensions Height with drums cm / in. Width with single drum cm / in. Width with dual drums cm / in. Depth with drums cm / in. Weight with dual drums 9.9 kg / 21.9 lbs. (Top to bottom) Single-chamber drum, Dual-chamber drum, and Abrasion drum 10-degree lift (wedge) 118

121 Physical Testers Agilent 350 Tapped Density Tester and Accessories Reduce the Noise The optional acoustic cabinet helps with sound control by reducing the noise level from an operating tester while providing visibility of the instrument through the front Plexiglass door. See page 121 for ordering information. Through a standardized and repeatable procedure, the 350 Tapped Density Tester measures the tapped or packed volumes of powders, granulated and flaked materials. The tester s unique tapping and rotary action packs material evenly to create a level surface for direct reading of measurements within the graduated cylinder. The tester is available in either a single- or dual-platform and the dual version allows for testing to start and stop at the same time. Platforms conform to either USP specifications or ASTM standards for tapped density testing. Locking cylinder platforms ensure the glass cylinders are held firmly in place. The tester allows for a 14 ± 2.0 mm drop height for the USP Method I version, and a 3 ± 0.2 mm drop height for the USP Methods I and II and ASTM versions. Depending upon the type of tester compliance, speeds of 300 taps per minute for the 14 mm drop and 250 taps per minute for the 3 mm drop, are maintained. Single- or dual-platform configurations available in either USP Method I, USP Method II or ASTM versions. Choice of 10, 100 or 250 ml graduated cylinders with a funnel top. Graduated cylinders with a standard top are available in 25, 50 and 500 ml sizes. Platforms are specific for USP or ASTM testing procedures and are designed to hold specific size cylinders. An optional printer can be factory-installed or retrofitted at a later date. 350 Tapped Density Tester, dual-platform with 100 ml graduated cylinder 119

122 Physical Testers 350 Tapped Density Tester USP Method I, 14 mm drop Single-platform Dual-platform 350 Tapped Density Tester, 115V, 100 ml Tapped Density Tester, 230V, 100 ml Tapped Density Tester, 115V, 250 ml Tapped Density Tester, 230V, 250 ml USP I and II and ASTM Methods, 3 mm drop Single-platform Dual-platform 350 Tapped Density Tester, 115V, 250 ml Tapped Density Tester, 230V, 250 ml Tapped Density Tester, 115V, 100 ml Tapped Density Tester, 230V, 100 ml Tapped Density Tester, single-platform with 100 ml graduated cylinder 350 Tapped Density Tester Optional Printers Printer, 115V/230V Printer, retrofit, 115V/230V

123 Physical Testers 100 and 250 ml graduated cylinders 350 Tapped Density Tester Accessories Tapped Density Tester Platforms Platform, 10 ml, 14 mm drop, USP Platform, 25 and 50 ml, 14 mm drop, USP Platform, 100 ml, 14 mm drop, USP Platform, 250 ml, 14 mm drop, USP Platform, 500 ml, 14 mm drop, USP Platform, 10 ml, 3 mm drop, USP or ASTM Platform, 25 and 50 ml, 3 mm drop, USP or ASTM Platform, 100 ml, 3 mm drop, USP or ASTM Platform, 250 ml, 3 mm drop, USP or ASTM Graduated Cylinders Graduated cylinder, funnel top, hexagonal base, 10 ml Graduated cylinder, funnel top, hexagonal base, 100 ml Graduated cylinder, funnel top, hexagonal base, 250 ml Graduated cylinder, standard top, hexagonal base, 25 ml Graduated cylinder, standard top, hexagonal base, 50 ml Graduated cylinder, standard top, hexagonal base, 500 ml Acoustic Cabinet Acoustic cabinet Note: Select the correct platform and cylinder combination to ensure the cylinder is properly held in place. Acoustic cabinet 350 Tapped Density Tester Dimensions Height (14 mm drop with platform) Width Depth 26.7 cm / 10.5 in cm / 12 in cm / 11.1 in. Height (14 mm drop with 100 ml cylinder) 53.4 cm / 21 in. Height (14 mm drop with 250 ml cylinder) 56.5 cm / in. Weight (dual platform without cylinders) 12.3 kg / 27 lbs

124 Service and Qualification Service and Qualification Agilent Services and Support: Your Laboratory Partner Agilent offers you a variety of comprehensive qualification and service options for your dissolution apparatus and analytical instruments. Focus on what you do best and let Agilent provide you with installation and familiarization, hardware and software training, and complete qualification services. Our service organization has the experience, education and training to ensure your dissolution equipment is properly installed and qualified, not only at the time of purchase, but throughout the life of the instrument. Our engineers and chemists are cgmp-trained and receive extensive ongoing training to ensure they have the requisite knowledge. We can work with you to develop a service offering that meets your specific needs for: Instrument maintenance and repair Regulatory compliance Software and data systems Training and educational services We can help optimize your productivity by quickly resolving problems, maximizing your equipment uptime, adhering to agreed-upon service and qualification schedules, minimizing your compliance risk and reducing your administrative burdens. Preventative Maintenance and Repair Service Keeping your dissolution apparatus in top condition is critical to meeting current USP Performance Verification Test (PVT) requirements, as well as the recent enhanced Mechanical Qualification (MQ) specifications put forth by the FDA and ASTM. It is even more important that your apparatus are routinely serviced. We offer a number of repair contract options that cover maintenance, repair and qualification services. For Agilent's Service Center Repair information, visit

125 Service and Qualification Qualification Documentation Maintaining the proper instrument and qualification documentation is essential. To ensure you meet the cgmp requirements, Agilent provides qualification guides for all our dissolution and physical testing instrumentation. Our qualification guides include installation qualification (IQ), operational qualification (OQ), and in the case of Apparatus 1, 2 and 3, a performance qualification (PQ) based on the USP Performance Verification Test (PVT). A mechanical qualification (MQ) guide is also available. Our PQ guide contains current USP practices for qualification with current acceptance criteria. Similarly, the MQ guide accurately reflects the current specifications and tolerances for physical parameters contained in the ASTM and FDA procedures. These guides are included with service purchases or can be ordered separately. Our dedicated compliance group strives to ensure this documentation remains current according to the ever-changing industry regulations. Compliance Services Our laboratory services group provides a cost-effective alternative to performing these qualification services. You can be assured the job will be performed correctly. In fact, Agilent is ranked #1 in compliance by lab professionals worldwide. Our service group can handle the PQ for Apparatus 1, 2 and 3. We offer these services for our own equipment, as well as for all other brands of dissolution apparatus. We will work with you or your metrology department to establish a schedule to ensure your equipment remains qualified. When performing a PQ for Apparatus 1 and 2, our services include a verification of the critical physical parameters and the chemical qualification using your USP prednisone tablets with either the single- or two-stage procedure for paddles and/or baskets. For customers who choose to perform the MQ procedure, we provide this service as well. Our engineers are equipped with our electronic qualification tools to measure all the relevant physical parameters. Our guides include the specifications as outlined in the USP, as well as the FDA and ASTM recommendations. Training and Educational Services Agilent offers training on the proper operation of all its equipment. This service can be ordered at the time of instrument purchase. We also offer a variety of other educational programs that are taught in our Cary, NC facility, or at your site. Contact your Agilent representative for more information or to set up a time to discuss your specific needs

126 Service and Qualification Did You Know? A wide variety of preventive maintenance and service agreements are available for all of Agilent's dissolution and physical testing instruments. Contact your local Agilent representative to find the solution that best fits your laboratory's needs. Compliance Services Service 708-DS and 709-DS Dissolution Apparatus IQ Service SYS-DI-708 2N OQ Service SYS-DI-708 2B PQ Service SYS-DI-708 2P MQ Service SYS-DI-708 2M /7010 Dissolution Apparatus IQ Service SYS-DI N OQ Service SYS-DI B PQ Service SYS-DI P MQ Service SYS-DI M Dissolution Apparatus IQ Service SYS-DI N OQ Service SYS-DI B PQ Service SYS-DI P MQ Service SYS-DI M Dissolution Apparatus IQ Service SYS-DI N OQ Service SYS-DI B PQ Service SYS-DI P MQ Service SYS-DI M DS Dissolution Apparatus IQ Service SYS-DI-705 2N OQ Service SYS-DI-705 2B PQ Service SYS-DI-705 2P MQ Service SYS-DI-705 2M Qualification Guide * *Qualification guides are included as part of AIQ services and do not need to be ordered separately. (Continued) 124

127 Service and Qualification Compliance Services Service Qualification Guide * BIO-DIS Reciprocating Cylinder Apparatus IQ Service SYS-DI-BIO 2N OQ Service SYS-DI-BIO 2B PQ Service SYS-DI-BIO 2P Reciprocating Holder Apparatus 7 IQ Service SYS-DI-APP7 2N OQ Service SYS-DI-APP7 2B DS Apparatus 7 IQ Service SYS-DI-400 2N OQ Service SYS-DI-400 2B Rotating Bottle Apparatus IQ Service SYS-DI-RBOT 2N OQ Service SYS-DI-RBOT 2B Dissolution Sampling Station IQ Service Add "-E" to SYS-DI-XXX 2N OQ Service Add "-E" to SYS-DI-XXX 2B Dissolution Sampling/HPLC Injector IQ Service Add "-E" to SYS-DI-XXX 2N OQ Service Add "-E" to SYS-DI-XXX 2N Dissolution Workstation Software IQ Service Add "-E" to SYS-DI-XXX 2N OQ Service Add "-E" to SYS-DI-XXX 2B *Qualification guides are included as part of AIQ services and do not need to be ordered separately. (Continued) Compliance Services Ordering Example Quantity DS, 8000 IQ Service (includes documentation) SYS-DI-708-E 2N DS, 8000 OQ Service (includes documentation) SYS-DI-708-E 2B DS PQ Service (includes documentation) SYS-DI-708 2P

128 Service and Qualification Compliance Services Service Cary 60 Multicell UV Dissolution System and Cary WinUV Software (software version 4.0 and higher) IQ Service SYS-UV-50 2N OQ Service SYS-UV-50 2B Cary 50/60 calibration service SYS-UV-50 2V Cary 60 Fiber Optic UV Dissolution System and Cary WinUV Software (software version 4.0 and higher) IQ Service SYS-UV-50 2N OQ Service SYS-UV-50 2B Cary 50/60 calibration service SYS-UV-50 2V UV Dissolution System and Cary WinUV Software (software pre-version 4.0) IQ/OQ for UV Multicell Dissolution SYS-UV-50 2N Software (version 2.5) IQ/OQ for UV Fiber Optic Dissolution Software (version 2.1) SYS-UV-50 2B UV Dissolution System IQ Service (Base system) SYS-UV-VIS R22N091 Included OQ/PQ Service (Base system) SYS-UV-VIS R22B091 Note: Add R22K091 per optional accessory Included IQ Service (System) SYS-UV-VIS-E R22N091 Included OQ/PQ Service (System) SYS-UV-VIS-E R22B091 Note: Add R22K091 per optional accessory Included ChemStation Software (General Purpose) for 8453 UV Dissolution System IQ Service (General purpose) R1009A Included IQ Service R1009A #001 Included (One additional software module) IQ Service (Security pack) R1009A #002 Included OQ/PV Service (General purpose) R1010A Included OQ/PV Service (Security pack for R1010A #001 Included one additional software module) OQ/PV Service (One workstation) R1010A #002 Included OQ/PV Service (Security pack for server share tests) R1010A #003 Included Qualification Guide * *Qualification guides are included as part of AIQ services and do not need to be ordered separately. (Continued) 126

129 Service and Qualification Compliance Services Qualification Guide Service * 100 Automated Disintegration Apparatus IQ Service SYS-DI-PHYS 2N OQ Service SYS-DI-PHYS 2B Tablet Hardness Tester IQ Service SYS-DI-PHYS 2N OQ Service SYS-DI-PHYS 2B Friability Tester IQ Service SYS-DI-PHYS 2N OQ Service SYS-DI-PHYS 2B Tapped Density Tester IQ Service SYS-DI-905 2N OQ Service SYS-DI-905 2B *Qualification guides are included as part of AIQ services and do not need to be ordered separately

130 Educational Services and Industry Support Dissolution Seminar Series Agilent Dissolution Systems offers educational seminars that are specifically designed to provide the latest in theory, techniques and hands-on training for those involved with dissolution testing. Our instructors include Agilent employees, as well as prominent scientists from academia and the dissolution industry. What makes these courses unique? The courses are not disguised sales presentations, with all course materials being vendor-neutral and designed to provide a solid base of knowledge. Also, course materials are relevant to a GMP environment. Our chemists understand the latest regulations and what it takes to comply. These courses are offered at our Cary, NC training facility on a yearly schedule, or taught onsite, anywhere around the world. For a complete list of seminar dates and locations, please check our web site at Fundamentals of Dissolution This comprehensive two-day course is designed for new and emerging dissolution analysts. The course places emphasis on basic dissolution fundamentals and theory, along with focused discussions on current compendial dissolution testing apparatus, USP physical parameter requirements and the current USP calibration procedure. Hands-on workshops provide participants with experience preparing for and executing a dissolution test. This course will benefit novice, as well as experienced, dissolution analysts and those in quality control and assurance, calibration, and metrology. This course also serves as a refresher for those individuals with limited or intermediate dissolution experience. The hands-on workshops include dissolution apparatus familiarization, performing the dissolution test, and physical suitability testing. Topics: Evolution of dissolution testing Dissolution fundamentals and theory Compendial dissolution testing Calibration of USP Apparatus 1 and 2 Critical physical parameters Compendial and non-compendial drug release apparatus Methods of sample analysis Dissolution technique Regulatory issues Upon successful completion of this course, the attendee should be able to: Describe basic principles of dissolution theory and compendial Apparatus 1 through 7 Perform proper dissolution techniques to conform with USP guidelines List critical physical parameters associated with Apparatus 1 and 2 Describe essentials in USP and enhanced mechanical qualification of Apparatus 1 and 2, as well as regulatory issues associated with dissolution and GMP guidelines 128

131 Educational Services and Industry Support Dissolution Method Development and Validation Designed for experienced R&D, method development, or QC chemists interested in the development and validation of discriminating in vitro dissolution methods, this highly intensive two-day course offers an interactive approach to the selection of a discriminating method, including discussion of biorelevant media and test conditions and an examination of appropriate testing equipment. New advancements in noncompendial apparatus and automated equipment (including fiber optics) in regards to innovative method development are also explored. The Biopharmaceutics Classification System will be an integral part of the method development aspects. Accompanying these topics are presentations of regulatory guidelines for concise method validation and instructional exercises designed to enhance the student s learning experience. Participants will be encouraged to share their method development experiences and problems. This course is designed for individuals involved with research and development, quality control/quality assurance, and pharmacokinetics. Topics: Overview of in vitro method dissolution Goals for dissolution method development Selection of test conditions Discrimination challenges Specification setting Test method generation Validation of the dissolution method Method transfer Upon successful completion of this course the attendee should be able to: Develop a dissolution method according to current regulatory guidelines Assess the discriminatory power of your dissolution method Determine sources of error associated with the proposed method Perform thorough validation of all manual and automated methods Explore all aspects of method transfer 129

132 Educational Services and Industry Support Correlating Dissolution and Bioavailability: Understanding IVIVC This two-day course is designed for advanced dissolution analysts and individuals involved with analytical method development and validation, as well as quality control/assurance, formulations, stability, pharmacology, pharmacokinetics and regulatory affairs. In vitro dissolution tests seem to be the most reliable predictors of in vitro availability. While the bioavailability of drug substances and drug products in humans can provide evidence of a potential relationship between dissolution and physiological availability, it is often impractical to perform extensive and expensive human testing. The goal of the course is to learn how to assess and develop methods of correlating in vitro and in vivo performance parameters. Topics: Fundamentals of correlation Bioavailability assessment Dissolution and bioavailability Basics of in vitro / in vivo correlation Characterization of dissolution data IVIVC parameters Upon successful completion of this course the attendee should be able to: Discuss relevant aspects of dissolution and bioavailability Describe essentials of bioavailability assessment regarding various dosage forms Outline fundamentals of interpretation of dissolution profiling and data Explain regulatory perspective of IVIVC and SUPAC guidelines Characterize dissolution data Reduce, analyze, and interpret IVIVC data 130

133 Educational Services and Industry Support In Vitro Dissolution of Ointments, Creams, and Transdermals Designed for academic researchers and industry scientists with interests in evaluating drug release from topical preparations, the goal of the two-day course is for the participant to learn the application of current dissolution testing techniques and equipment in the evaluation of drug release from semisolids and transdermal drug delivery systems (both immediate and controlled release). Discussion includes the use of this technology in product development and quality control. This course is designed for individuals involved in the development, manufacturing, or quality control of topical products. Topics: Compendial testing with Apparatus 5, 6, and 7 New compendial chapters on diffusion cell technology Method validation Non-compendial testing Aspects of membrane selection Proposed calibration methodology SUPAC guidance Use of the Enhancer Cell and Franz Cell Method development World community regulatory requirements The hands-on workshop includes: Use of the Enhancer Cell and Franz Cell Data analysis Method development Demonstration of Apparatus 5, 6, and 7 Upon successful completion of this course the attendee should be able to: Describe basics of compendial dissolution testing with USP Apparatus 5, 6, and 7 Outline uses and restrictions of non-compendial testing and apparatus Explain uses of the Enhancer Cell and Franz Cell Describe ointment, cream, and transdermal method development and validation techniques Describe SUPAC guidelines for topicals Explain regulatory requirements with perspective on the world community 131

134 Educational Services and Industry Support Dissolution and Bioequivalence of Generic Pharmaceuticals This intensive two-day course is designed for the advanced dissolution analyst, as well as those involved in drug metabolism, drug disposition, generics, pharmacokinetics, and analytical methods development. Participants involved with research and development, quality control/quality assurance, and pharmacokinetics learn how to demonstrate bioavailability and bioequivalence of pharmaceutical formulations without designing and executing time consuming and expensive clinical trials in humans. Two pharmaceutical formulations are considered bioequilivent (BE) when their respective rate and extent of bioavailability (BA) following administration of a unit dose under standard clinical experimental conditions are substantially similar. In vitro testing is an ideal surrogate for predicting BA or BE of pharmaceutical formulations. This course presents the fundamental considerations necessary to understand BA or BE and the utility of in vitro dissolution testing in the prediction of BA or BE. Topics: Biopharmaceutics Classification System (BCS) Dissolution method development for generic formulations Characterization/computation of dissolution parameters f 1 and f 2 equations IVIVC relevant to generics Computation of PK parameters for BA/BE Worldwide regulatory requirements for demonstration of BE, design of a clinical protocol Upon successful completion of this course the attendee should be able to: Understand BCS and dissolution testing Develop dissolution test method development for generic formulations Use f 1 and f 2 expressions in generic drug development Comprehend IVIVC relevant to generic pharmaceuticals Compute PK parameters for BA and BE Design basic clinical protocol Dissolution Seminar Series For more information on dissolution seminars, visit For more information regarding on-site courses, contact your local Agilent representative

135 Educational Services and Industry Support Self-paced Learning Dissolution 1-on-1 Syllabus for Dissolution Training This CD-based dissolution training program is organized into four main sections with reference material. An introduction with information on what happens when medicine enters the body and an overview of dissolution testing, instruments and data collection. Section 2 includes specifics for dissolution Apparatus 1 and 2, compendial information, critical physical parameters, calculation and analysis. Section 3 discusses calibration of Apparatus 1 and 2, physical and chemical calibrations and failure investigations. The supplemental section includes information on automated testing, sampling, analysis, data reduction, clean up and changeover. Reference materials include regulatory information, observations, SOPs and helpful resources. Agilent offers the Dissolution 1-on-1 self-paced learning curriculum where you can complete the training from anywhere. We compiled a comprehensive, virtual seminar on dissolution from Apparatus 1 and 2 operation to calibration; automated testing to regulatory issues and packaged it on a single CD that makes the information easy to learn outside a classroom setting. This interactive course is designed for the individual so scientists and technicians can learn at their own pace. Adapted from the highly successful Agilent Fundamentals of Dissolution seminar, the comprehensive CD includes much of the material from the two-day course. The Dissolution 1-on-1 CD makes it possible to learn at your own pace right from your computer. Training can be accomplished on-site in a standardized format that ensures consistency for your entire organization. Mastery of the material is assured via a comprehensive exam completed online after studying the CD. Test results are communicated back to the student and the designated administrator. As the dissolution test continues to gain in prominence within the pharmaceutical industry, standardized testing is important to ensure that scientists around the world are similarly trained. Document that your scientists and technicians are following the major pharmacopoeias with this CD today! Dissolution 1-on-1 CD Dissolution 1-on-1 CD Initial CD for 10-user license, 1 year Dissolution 1-on-1 CD Second CD for additional 10-user license, 1 year

136 Educational Services and Industry Support Video Training Labcast: Live from the Agilent Global Broadcast Studio What is Labcast? In simple terms, Labcast is a way for Agilent to communicate through video conferencing equipment with other capable sites around the world. Video broadcasting from our studios in Cary, NC allows instantaneous conferencing, training and services to all points around the globe. Agilent trainers can televisit you and your employees to explore the latest methods and techniques for effective dissolution testing. Keep your lab personnel updated on new practices with ongoing education programs and even link with other locations for standardized training sessions. All this without leaving home. Contact us to learn more! Dissolution Apparatus Qualification; PVT versus MQ, What is Right For Your Laboratory 60-minute module Agilent s Laboratory Services has prepared a one-hour seminar on the qualification of USP Apparatus 1 and 2. Significant changes have occurred in dissolution apparatus qualification during the last several years. The USP Performance Verification Test (PVT) migrated from a range test to a much more definitive test which focuses greatly on accuracy and variability of the dissolution apparatus through new acceptance criteria highlighting the geometric mean and %CV. Likewise, the alternative approach towards apparatus qualification, enhanced Mechanical Qualification (MQ) will also be highlighted and discussed in detail. The module addresses the following topics: Overview of the Dissolution Performance Verification Test Background of Performance Qualification (PQ) and Analytical Instrument Qualification (AIQ) Dissolution Mechanical Qualification (MQ) standards, requirements, specifications and tolerances PVT and MQ: finding the right test for your laboratory Evaluation of why laboratories are using the MQ test 134

137 Educational Services and Industry Support Dissolution Aberrant Data Investigation 60-minute module Lack of proper failure investigation and documentation generally leads the list of problems in FDA observations of analytical laboratories. Many standard operating procedures for handling out-of-specification data do not properly deal with dissolution data. Join our chemists for a live seminar on the proper procedures for investigating and documenting out-of-specification dissolution test results in your lab. The module addresses the following topics: Detailed procedures for properly investigating and documenting out-of-specification results Ideas about how rudimentary investigations may uncover calculation or standard preparation errors proceeding to additional testing Discussion on how proper investigation and reporting can limit the possibility that an analyst will repeat an error in a second test Review of actual FDA observations Apparatus 3 60-minute module The reciprocating cylinder, or Apparatus 3, became an official method in the USP XXII, Fifth Supplement. Given the increasing introduction of modified and extended release products, this valuable tool is growing in usage. This one-hour presentation covers the historical development as well as the principles of the operation and is designed for anyone interested in learning how the instrument operates. The module addresses the following topics: Evolution of Apparatus 3 from previous dissolution apparatus Principles of operation Demonstration of Apparatus 3 When to consider Apparatus 3 in method development Calibration requirements Automation of the sampling process Options / accessories for unique dosage forms 135

138 Educational Services and Industry Support Dissolution Discussion Group Tap into the knowledge-base from dissolution users around the world! The Agilent-sponsored DDG is a vendor-neutral online forum designed to host discussions on industry research, best practices, regulatory issues, R&D challenges and more, all in an open environment that is free from regulatory oversight. Discussions are anonymous and supported by fellow analysts and chemists in QC, R&D, stability and academia. Immediate Release News DDG members receive a free, bimonthly copy if Immediate Release News, your source for linking to the latest dissolution-related information, helping you navigate the constantly changing pharmaceutical environment. Simply join the DDG on to receive your copy! 136

139 Educational Services and Industry Support Practical Solutions Newsletter You can have this dissolution-specific newsletter delivered right to your inbox! With the latest on our dissolution products, services and the ever-evolving regulatory environment, Practical Solutions is your resource to stay informed. To receive your copy, register at Dissolution Hotline Agilent's dissolution chemists are always available to assist with questions about finding the instrument that best supports your laboratory, method development and regulatory support. Contact our team at 137

140 Index , , , , , , , , , , , , , V V V V V V V V V V V V

141 Index V , V , V...17, , 26, 72, V...14, 17, , 26, V...17, , V , , 17, V...14, 17, , V...17, , 17, V...17, , 17, V...17, , V , , V , V , 26, V , 29, , 29, , , V...19, V V V V V V V V , , , 17, 24, 56, V...17, , V , , V , V V V , , V V V

142 Index V , , , , , V...19, , V...19, , , , 19, V...19, , V...19, , , 29, V V , , , 29, 32, , V V V V V V V V , , , , , , , , , , , , , , , , , ,

143 Index , , , , , , , , , , , , , , , , , , , , , , , , ,

144 Index V V V V V V V V V V

145 Index , , D...92 G1118AA...92, 94 G1127A...92, 94 G1128A...92, 94 G1129A...92, 94 G1130A...92 G1811A...92 G1812AA...92 G1815AA...92, 94 G7900AA...92, 94 G7920A...93 G7921A...93 G7922A...93 K K K K K K K K K K K K K K K , 21 K , 21 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 11, 20 K , 20 K , 20 K , 20 K , 20 K , 20 K , 21, 36 K , 21, 36 K , 21, 36 K , 21, 36 K , 20 K , 20 K , 20 K , 20 K K , 11 K , 15 K , 15 K , K , 15 K , 15 K , 15 K K K K K K K K K , 14-15, 21 K , 15 K K K , 15 K K K K R1009A R1009A # R1009A # R1010A R1010A # R1010A # R1010A # SYS-DI-400 2B SYS-DI-400 2N SYS-DI B SYS-DI M SYS-DI N SYS-DI P SYS-DI B SYS-DI M SYS-DI N SYS-DI P SYS-DI B SYS-DI M SYS-DI N SYS-DI P SYS-DI-705 2B SYS-DI-705 2M SYS-DI-705 2N SYS-DI-705 2P SYS-DI-708 2B SYS-DI-708 2M SYS-DI-708 2N SYS-DI-708 2P SYS-DI-905 2B SYS-DI-905 2N SYS-DI-APP7 2B SYS-DI-APP7 2N SYS-DI-BIO 2B SYS-DI-BIO 2N SYS-DI-BIO 2P SYS-DI-PHYS 2B SYS-DI-PHYS 2N SYS-DI-RBOT 2B SYS-DI-RBOT 2N SYS-UV-VIS R22B SYS-UV-VIS R22N SYS-UV-VIS-E R22B SYS-UV-VIS-E R22N

146 Alphabetical Index degree Lift (Wedge)...116, Automated Disintegration Apparatus...49, , ml Conversion Kit Infinity LC System Infinity LC System Infinity LC System CFR Part , 57, 62, 64, 86-87, 92, 99 2L 708-DS Dissolution Apparatus , Conversion Kit Vessel , 26, 28-29,...36, 49, 69, ml Conversion Kit , 29-32, 45, , Tablet Hardness Tester , Friability Tester , Tapped Density Tester , fin Basket...13, 16-17, DS Apparatus 7...5, 57-59, 125 5/6 500 ml Sampling Kit...11, 21, 34-36, Height/Center Qualification Station DS Dissolution Apparatus Discontinued, see 708-DS Dissolution Apparatus 708-DS Dissolution Apparatus , 16-22, , 29-30, 32, 34, 36, , 45, 47-49,...62, 67, 70-75, 77, 83-84,...87, 93-94, , 124, DS Dissolution Apparatus...5, 7-9, 12-22, 25-27, 29, 34, 37, 41, 47, 62, 67, 71-72, 75,...84, 93-94, 104, Heater/Circulator Syringe Pump...51, 54, 62, 70-74, , 82-83, 96-97, Filter Changer...38, 51, 54, 62, 70-74,...76, 78-79, 82-83, 85, 96-97, Peristaltic Pump...7, 62, 70-77, 79-83, , Dissolution Sampling Station...6-7, 34, 51,...54, 62, 70-81, 84-85, 95-97, , 124, Dissolution Sampling/HPLC Injector...62,...75, 82-83, 107, UV Dissolution System or Spectrophotometer...7, 84-94,...104, 126 A AIQ (Analytical Instrument Qualification)...7, , 134 API (Active Pharmaceutical Ingredient)...5, 46,...57, 108 Abrasion Drum...116, 118 Acoustic Cabinet...119, 121 Acrylic Water Bath Active Pharmaceutical Ingredient (API)...5,...46, 57, 108 Adhesive, Medical...42 Adjustment Tool , Alignment Post...6, 9-10, Alignment Tool Alza, Apparatus Amber vessel , 14-15, 18-19, 21, 27-29,...55, 58, 60-61, 75, 93 American Society of Testing and Materials (ASTM)...3-4, 6, Analytical Instrument Qualification (AIQ)...7, , 134 Apparatus , 16, 22, 44, 62, 68-70, 92,...123, 128, Apparatus , 16, 22, 44, 62, 68-70,...92, 123, 128, Apparatus 3...5, 50-51, 56, 62, 123, 128, 135 Apparatus , 42, 62, 70, 128, 131 Apparatus , 42, 62, 70, 128, 131 Apparatus 75, 42, 48, 54-58, 62, 72, 74, 125, 128 ASTM (American Society of Testing and Materials)...3-4, 6, Autocalibration Block...71, 75, 80, 82 Automated Sampling, Autosampling, Autosampler...6-9, 13-15, 20, 30, 34-35, 37-38,...57, 62, 70, 72, 91-92, 94, 99, 104 Automation Filter...38 AutoTemp In-vessel Temperature Measurement...6-7, 9, 12-14,...32, 34, 37, 72, 93-94, B Barbed Fitting...77 Barbed Tubing Adapter...49 Basket Shaft...5-9, 12 Basket Hanger Basket Rack Basket Shaft Support Rack...21, 26 Basket 3-fin...13, 16-17, 24 Bolus...16, Disintegration Durafit...17, 22-23, 26 Gold-plated...16, 24 Mesh...5, 16, 23-24, 109 Mini , 23-24, 26, 30, 54 Rotating Basket...5-9, 12-14, 16-18, , 26, 30 Sinker...33 Suppository...16, 24, 109 Teflon-coated , 24 Verified...8, 14-16, 22, 109 Battery , 114 Beaker...108, 110 Bent Cannula Bioavailability...108, 130, 132 BIO-DIS Reciprocating Cylinder Accessories Conversion Kit...51 Inner Sample Tube...52 Lower Cap...52 Outer Media Tube...52 Retrofit...51 Screen...53 Upper Cap...52 Vessel Carrier...50, 52 Biorelevant/biorelevance...5, 50, 54, 129 Bolus Baskets...16, Brush, Tablet Fragment Bulkhead Fitting...49 Bundle...8, 14, 93, 104 C COC (Certificate of Conformance)...16, 27, 109 Cabinet, Acoustic...119, 121 Calibration Fixture...74, 113 Tube...75 Weight Weight Hanger Cannula Extension...34, 36, 75 Return...8, 14, 20, 36, 52, 75-77, 88, Sample/Return...20, 52, 76 Sampling...9, 34, 36, 38-39, 71, 75-77,...88, Cap Decanting Viton Liner Capsule Japanese Sinker Basket...33, 41 USP Sinker...33 Weight...33 Wire...33 Carrying Case Carryover...96, 98 Cartridge, Peristaltic Pump...74, Cary 50 UV Dissolution System see Cary 60 UV Dissolution System Cary 60 UV-visible Spectrophotometer/UV Dissolution System...2, 7, 78-79, 80, 84-86, , 126 Cary 50 UV-visible Spectrophotometer see Cary 60 Spectrophotometer/UV Dissolution System Cary WinUV Dissolution Software , , 107, 126 Case, Carrying Cell Changer...84, 95-97, Centering Ring...27, 30, 36, 40-41, 69 Tool...69 Certificate of Conformance (COC)...16, 27, 109 ChemStation UV-visible Software , 89, , 107, 126 Chinese Pharmacopeia (CP) ,

147 Alphabetical Index Clamp, Tubing Closed-loop Collector, Sample see 8000 Dissolution Sampling Station Collet...23, 25-26, 31, 45 Color-coded Tubing...20, Compendial...4, 33, 57, , 131, 133, Compliance Service Conical Head Shaft...17, 22-23, 26 Connector Controlled Release Conventional Filter Tip , 79 Conversion Kit ml , 29-32, 45, ml , 29-32, 45, 61, 93-94, 104 2L...20, Large-volume...20, Small-volume , Converter Contact Lens...59 Correlating Dissolution and Bioavailability: Understanding IVIVC Seminar Cover, Evaporation...6-7, 10, 12-15, 18, 21, 27, , 36, 40-41, 45, 52, 57, 59, 102 Cream...5, 44, 131 Cup, Suspension Cuprophan...43, 45 Cuvette Holder...89, 91, 102 Cylinder Platform Cylinder, Graduated D DDG (Dissolution Discussion Group) DDM (Dosage Delivery Module) , 13-15,...21, 34, 41, 72, 94, DVH (Direct Vessel Heating) , , 21, Decanting Cap Depth/Height, Gauge...43, 68 Direct Vessel Heating see DVH Disintegration 100 Automated Disintegration Tester...49, , 127 Basket Beaker Fluted Disks Water Bath...49 Diode-array Spectrophotometer see 8453 UV Dissolution System or Spectrophotometer Disk, Plastic Dissolution 1-on-1 CD Dissolution and Bioequivalence of Generic Pharmaceuticals Seminar Dissolution Apparatus 400-DS...5, 57-59, DS , 16-22, 25-27, 29-30, , 36, 41-42, 45, 47-49, 62,...67, , 83-84, 87, 93-94, , 124, DS...5, 7-9, 12-22, 25-27, 29, 34,...37, 41, 47, 62, 67, 71-72, 75,...84, 93-94, 104, 124 Apparatus 1...5, 6-15 Apparatus 2...5, 6-15 Apparatus 3...5, Apparatus 5...5, 6-15, Apparatus 6...5, 6-15, Apparatus 7...5, BIO-DIS...5, 50-53, 72, 125 Paddle Over Disk...5, Reciprocating Cylinder...5, Reciprocating Holder...5, Rotating Basket...5, 6-15 Rotating Cylinder...5, 6-15, Rotating Paddle...5, 6-15 Dissolution Discussion Group (DDG) Dissolution Hotline Dissolution Method Development and Validation Seminar Dissolution Sampling Systems, Automated Dissolution Tester See Dissolution Apparatus Dissolution Workstation Software...7, 51, 54, , 62-63, 71, 82-83, 125 Dosage/dosage form...2, 4-9, 12-14, 18, 22,...27, 33-34, 38, 50, 54, 57, 60,...85, , , 130, 135, 140 Dosage Delivery Module (DDM) , 13-15,... 21, 34, 41, 72, 94, Drain Valve...49 Drug-eluting Stent (DES)...5, 57 Drug Release...4, 5, 57, 60, 78, 128, 131, Drum, Friability Dual-chamber Friability Drum Dual-drum Friability Tester , 127 Durafit...17, 22-23, 26 Dura-Tef Shaft...25 E EaseAlign Vessel/Centering Ring , 31,...36, 40-41, 45, 64, 67, 69 Educational Seminar Electropolished Stainless Steel, Basket or Paddle...9, 14, 17, 22, , 45, 72, 103 Enhanced Mechanical Calibration see Mechanical Qualification Enhancer Cell...5, 28, 44-45, 131 Enteric-coated...5 Environmental Chamber , 18, 27 Evaporation Cover...6-7, 10, 12-15, 18-21, 27, , 36, 40-41, 45, 102 Evaporation Plug...21, Extended Release...4-5, 50, 54, 57, 135 F FDA (Food and Drug Administration)...3-4, 6, , 135 Fiber optic Probe...98, 102 Fiber optic UV Dissolution System...103, 126 Filter Automation Filter...38 Changer...38, 51, 72-74, 76, 78-79, Conventional Filter Tip...38 Full Flow Filter , 38-39, 72, 82 Fitting, Water Bath Floating Dosage Form...5, 50 Flow Cell...84, 87-91, 95-97, , 104 Flow Deflector...49 Fluted Disk Food and Drug Administration (FDA)...3-4, 6, , 135 Fragment Brush Franz Cell...44, 131, Friability Testing , 127 Full Flow Filter , 38-39, 72, 82 Fundamentals of Dissolution Seminar G Gel...5, 44 Gauge Centering...67 Height...43, 68 Wobble...64, 67, 69 Generic Pharmaceuticals Glass Tube...52, 58, Glass Vessel 1L...5, 93, ml...19, 28-29, ml see 1L 2L...19, 28-30, 36, 69, ml , 28, 31, 32 Amber...15, 19, DVH TruAlign...12, 18-19, 27, 29 EaseAlign , 40 TruAlign...6-9, 12, 18-19, 27, 29, 32, 40, 45 TruCenter , 30, 32 Verified Gold-plated Basket...16, Shaft Graduated Cylinder...119, 121 H HPLC (High Performance Liquid Chromatography) Hanger Hardness Tester , 127 Harmonized/harmonization...6, 50, 108 Heater/Circulator...6, 21, 48-49, 54, 60-61, 108 Height Gauge...43, 68 Height Measurement Height Spacer High Performance Liquid Chromatography see HPLC Holder Acrylic Rod Angled Disk Cuvette Filter...35 Intrinsic...47 Reciprocating...5, 42, 54-56, 62, 74, 125 Sample Spring Stent...56, Transdermal...43, 55 Weighted Hotline

148 Alphabetical Index HPLC, Automated...82, HPLC Injector...62, 82-83, 107, 125 HPLC Vial...57, 71, 82 Hydrogel...5 I IQ (Instrument Qualification)...3, 7, IVIVC (in vitro / in vivo correlation)...130, 132 Immediate Release News Implant...4, 5, 54, 60 Infinity LC System Insert Cup...43 In Situ...6, 84, 98 Instrument Qualification see IQ Interchangeable Paddle/Basket Shaft ,...22, 26 Intrinsic Dissolution Apparatus Die...5, Holder Punch Surface Plate In-vessel Temperature Measurement, AutoTemp...6-7, 12, 34 In Vitro Dissolution of Ointments, Creams and Transdermals Seminar In vitro / in vivo correlation see IVIVC J/K Japanese Pharmacopeia (JP)...33 Japanese Sinker Basket...33, 41 Jaw Plate...112, L LC (Liquid Chromatography) Labcast Large Volume Conversion Kit Liquid Chromatography see LC Luer Lock Type Cannula , 54 M MCT (Multicell Transport)...88, 92, 101 MQ (Mechanical Qualification)...3-4, 6-7,...13, 16, 22, 27, 64-66, , 128, 134 Manifold...6-8, 10-15, 20-21, 29-30, 32, 34-37, 42, 45, 72, 75, 84, 88-90, 93-98, 104, Manual Sampling...8, 14, 31, 34-36,...41, 71, 75 Manuals, Qualification/Service Mechanical Calibration...65 Mechanical Qualification see MQ Media Replacement , 70-71, 74, 95 Mega Paddle...22, 25 Mesh...5, 16-17, 22-24, 33, 43,...53, 55-56, 59, 61, 72, Microparticle...5 Mini Basket , 23-24, 26, 30, 54 Mini Paddle...5, 17, 18-19, 22, 26, , 32, 37, Modified Release...5 Motorized Sampling Manifold...37, 71 Multi-apparatus...90, 93 Multicell Transport (MCT)...88, 92, 101 Multicell UV Dissolution System...7, , 126 Multicomponent Analysis...85, 92 Multiplexer...84, 98, N Needle, Replacement...75 NIST-traceable...66 O OQ (Operational Qualification).3, 7, 87, Offline UV Dissolution...91, Ointment...5, 44, 131 Online UV Dissolution...8, 30, 84, 87, 94-95, , 102, 104 Operational Qualification (OQ)...3, 7, 87, Ordering Information Osmotic Pump...5, 54 P PC Control...54, 71 PM (Preventive Maintenance) PQ (Performance Qualification).3, 123, PTV (Performance Testing Verification)...3,...123, 126 Paddle Over Disk Assembly Paddle Dura-Tef...25 Electropolished Stainless Steel...17, 22, Mega...22, 25 Mini...5, 17, 18-19, 22, 26, , 32, 37, PEEK...17, 22, 25-26, 35, 59, 78 Teflon-coated , 22, Verified...17, Paddle Support Rack...26 Paper, Printer...21, 65 Pathlength...98, Performance Qualification (PQ) see PQ Performance Testing Verification (PVT) see PVT Peristaltic Pump...7, 62, 70-77, 79-84, 89-90, , 99, 105 Pharmaceutical...2-4, 57, , 136 Pharmacopeia...3-4, 6, 18-19, 29, 44, 82 Physical Parameter...6-7, 64, 67, 123, 128, 133 Physical Testing Plastic Disk Plastic Tubing...29 Plastic Vessel...28 Plunger Assembly Powder...5, 33, 119 Preventive Maintenance (PM) Printer Paper...21, 65 Ribbon...65 Thermal , 14-15, 21 Probe... Fiber-optic , 98, 102 Temperature...6, 11, 20-21, 34, 57, 64, 110 Thermistor...48, 60 Punch, Intrinsic Q QAII C Mechanical Qualification Station...7, 13, QA/QC...2 Qualification Guide...27, Qualification Services R Reciprocating Cylinder 300 ml Vessel...5 Evaporation Cap...52 Lower cap...52 Upper cap...52 Reciprocating Disk Reciprocating Holder See Holder Release Rate...44, 50, 60 Replacement Screens Resident Cannula Kit...36 Resident Probe.21, 34, 41, 72, 78, 94, Retrofit...40, 51, 74, 111, , Return Cannulas...8, 14, 20, 52, 77, 88 Ribbon, Cartridge...65 Rinse Tray...21, 74 Rod, Basket Suspension, Rotating Basket.5-9, 12-14, 16-18, 20-24, 26, 30 Rotating Bottle Apparatus Bottle...61 Clip...61 Cap...61 Decant...61 Liner...61 Screen...61 Rotating Cylinder...5-6, 42-43, 68 Rotation...116, 118 RPM Sensor (Speed)...64 RPM Sensor (Magnetic) S Sample / Return Cannulas...8, 14, 20, 52, 77 Sample Collector...82 Sample Tube, Glass...52 Sampling... Automated...6, 8-9, 13-15, 20, 34,...38, 51, 70, 72, 91, 94, Cannula...9, 34, 36, 39, 71, 75-77, Manual...8, 14, 31, 34-36, 41, 71, 75 Manifold...11, 20-21, 31, 34, 37, 72, , 95-97, Tray...57, 71-72, 74 Scanning Spectrophotometer...85 Screen...5, 42-43, 50, 53, 60-61, Seminar Correlating Dissolution and Bioavailability: Understanding IVIVC Dissolution and Bioequivalence of Generic Pharmaceuticals Dissolution Method Development and Validation Fundamentals of Dissolution In Vitro Dissolution of Ointments, Creams and Transdermals Septum-capped vials

149 Alphabetical Index Services...3, 87, Shaft Basket...5, 8-9, 13-14, 16-17, , 26, 55-56, 68, 72 Calibrated...64 Paddle...7-8, 13, 16-17, 21-22, Shield, Fragment Shield, Safety Single-drum Friability Tester Sinker...33, 41 Sipper...82, Skin...5, 44, 54 Small-volume...5, 18-19, 30, 57 Software Cary WinUV Dissolution , , 126 ChemStation UV-visible..87, 89, 92-93, 126 Dissolution Workstation...7, 51, 54, 57-58, , 71, 82-83, 185 Spacer...31, 35, 60, 67-68, 108 Spectrophotometer...2, 7, 84-85, 87, , Spin On/Spin Off see Two-piece Interchangeable Paddle/Basket Shaft Stainless Steel, Electropolished Basket...17, 22 Paddle...17, 22, Stent...5, 54, Suppository...24, 109 Suppository Basket...16 Suspension Cup Rod Sustained Release...5, 50 Syringe Pump...38, 51, 54, 57, 62, 70-79, 83-84, , 99, , 140 Syringe...35, T Tablet...4-5, 9, 50, 54, 60, 86, , 123, 127 Tablet Fragment Brush Shield Tablet Hardness Tester , 127 Tachometer...64, 67, 69 Tapped Density Tester , 127 Technical Documentation...7, 13 Teflon Cell...44 Teflon-coated Basket...16, Paddle...17, 22, Shaft Teflon Tubing...81 Terms and Conditions Tester, Dissolution See Dissolution Apparatus Thermal Printer , 14-15, 21, Thermistor...48, 60 Thickness Gauge Timepoint...6, 11, 34, 38, 54, 57, 59, 62, 70-71, 78-82, 84, 87, 89-90, 95-98, 107 Tip Filter Training , Transdermal Patch Holder...43 Tray Rinse...21, 74 Sample...57, 59, 71-72, 74, 140 Trim Pot Tool TruAlign Vessel...6-7, 9, 12, 19, 27, 29, 32, 45 TruCenter Vessel , 30, 32 Tube Disintegration Basket Glass Sample...52 Tubing... Adapter...48 Clamp Color-coded...20, Kit Peristaltic Pump , 81 Plastic, PVC...49 Sample...72 Syringe Pump Teflon...81 Two-piece Interchangeable Paddle/Basket Shaft , 22, 26 U USP (United States Pharmacopeia) <724> Drug Release...42 <1087> Apparent Intrinsic Dissolution...46 <1724> Pharmacopeial Forum Chapter.44 Performance Verification Test (PVT)...3, 6,...28, 50, 123, 134 United States Pharmacopeia (USP)...5-6, 9, 17, 23, 25, 27, 29, 33, 35, 43, 45, 47, 51, 53, , 68-69, 72, 86, , 116, , 128, 131, Upgrade...20, 27, 60, 64-65, UV Dissolution... Software System...7, 37, 78, 80, 87-94, 126 UV-visible Spectrophotometer...7, 84-85, 87, , 95, 98, V Valve...49, 70, 72-78, 85, 89-90, Valve Sampling...86, 92 Verification Tool...7, 13, 35, Verified...8, 14, 16, 18, 22, 27, , 116 Verticality... Shaft Vessel...30, Vessel 1L...19, 27-29, 35-36, 42, 44, ml , 27-29, 31, ml see 1L 200 ml , 28-29, 31-32, 45, 92, 104 2L...9, 18-19, 28-29, 31-32, 69, 75, ml...19, 29, ml ml...28, 36 Amber...15, 28-29, 140 DVH TruAlign , 18-19, EaseAlign...28, 30 Glass...12, 31, 93, 104 Peak...5, 19, 28-29, 69 Plastic TruAlign...6-9, 11-12, 14, 18-19,...27, 29, 32, 40, 45 TruCenter , 30-32, 36, 40 Verified...8, 14-16, 18, 22, 27,...62, , 116 Vial Glass HPLC...57, 71, 82, 140 Septum-capped Viton Liner VanKel...2, 7, 34, 84, 87, 92 Varian...2, 7, 34, 48, 84, 87, 92 VK VK 100 see 100 Automated Disintegration Apparatus VK 200 see 200 Tablet Hardness Tester.. VK 5010 see 5010 Height/Center Qualification Station VK 7000/7010/7025/7030 Discontinued, see 708-DS and 709-DS Dissolution Apparatus VK 750D see 750 Heater/Circulator VK 806 see 806 Syringe Pump VK 808 see 808 Filter Changer VK 8000 see 8000 Dissolution Sampling Station VK 8020 see 8020 Dissolution Sampling/HPLC Injector VK Verified see Verified W Warranty Information Water Bath...6, 12, 21, 30, 40, 48-49,...57, 60-61, 64, 108, 110 Wavelength...85, 98, 100 Wedge...116, 118 Weight Hanger Weighted Holder Weight...33, 38-39, 42-43, 86, , 116, 121 Wire...33, Wobble Gauge...64, Workstation Software...7, 51, 54, 57, 58, , 71, 82, 125 X, Y, Z Zymark...17, 27,

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152 Ordering Information Ordering an Agilent 708-DS or Agilent 709-DS Dissolution Apparatus Questions to consider when preparing to order your 708-DS or 709-DS Dissolution Apparatus and system components 1. How many positions do you typically utilize for each dissolution test? Number of Positions: 6 or 8? 2. Do you require documented evidence of each dissolution test? Printer: Yes/No 3. Are you interested in automated dosage introduction? Select DDM option 4. Are you interested in individual vessel temperature monitoring? Include Vessel Temperature probes on manifold or Handheld Probe 5. What type of accessories might you require with your 708-DS? Shaft type? Paddle, Basket, or both? Vessel size/type? 6. Do you intend to use the 708-DS as a standalone instrument? Yes = No Manifold 7. Do you intend to use the 708-DS with an automated system? Autosampler (8000 Sampling Station) Pump Type (Peristaltic, Syringe, or Syringe Pump with Filter Changer for 0.45 micron filtration)? Sample Tray size (LC vials or Test tubes)? UV-Vis (Cary 50/60 or 8453)? 8. If an online UV system is desired: do you need sample archival? Size of flow cell (pathlength)? 9. PC required? Yes/No 10. Do you test any light sensitive products? Amber Vessels/Evaporation Covers 11. Would you require complete qualification of your instrument upon delivery? AIQ Services? 12. What method of periodic calibration is your laboratory currently using? PQ or MQ? 150

153 Agilent Technologies Order Form Outside the U.S. and Canada, please contact your local Agilent office or Authorized Distributor when ordering. Order Date Name: Title: Phone: Company: Company: Street: Room/Bldg/Dept: City: State/Province/Country: Zip/Postal Code: Deliver to: 708-DS/709-DS: Printer: DDM Option: Manifold Kit: EVT Probe: Accessory Kit: Shafts (Top): Shaft #1: Shaft #2: Vessels: Purchase Order or Credit Card Number & Expiration Shipping Address Taxable Y or N? Order Form Agilent Technologies If No, please provide Certificate # Fax: Billing Address Comment Qty. Price Total Price Choose base unit or one of the preconfigured 16-xxxx bundles. Choose printer option; not necessary if using 16-xxxx bundle. Choose DDM option; not necessary if using 16-xxxx bundle. Choose manifold option; not necessary if using 16-xxxx bundle. Add handheld temperature probe, if desired; not necessary if using 16-xxxx bundle. Choose accessory kit option; not necessary if using 16-xxxx bundle. Add appropriate quantity of receptor shaft; not necessary if using 16-xxxx bundle. Choose appropriate quantity for lower receptor shaft option. Choose appropriate quantity for lower receptor shaft option. Choose appropriate quantity for dissolution vessel option. Yes No 708-DS AIQ Services: 708-DS AIQ Guides: 8000 Sampling Station: 8000 Accessory Kit: 8000 AIQ Svcs.: 8000 AIQ Guides: Add appropriate AIQ services for 708-DS/709-DS. Add AIQ documentation for 708-DS/709-DS. Not required if services are ordered. Choose 8000 option for your automated sampling needs. Select the appropriate accessory kit based on sample tray/vial size. Add appropriate AIQ services for 8000 Sampling Station. Add AIQ documentation for Not required if services are ordered. UV Dissolution Software: UV Disso SW Accessory 1: UV Disso SW Accessory 2: UV Disso SW Accessory 3: UV Disso AIQ Services: UV Disso AIQ Guides: Choose UV Dissolution software option for your automated dissolution analysis. Add appropriate accessory (1) for online UV system. Add appropriate accessory (2) for online UV system. Add appropriate accessory (3) for online UV system. Add appropriate AIQ services for online UV system. Add AIQ documentation for online UV system. Not required if services are ordered. For additional assistance, visit to use the Dissolution Products Configuration Tool. Phone: (select option 1, then option 3) in the US and Canada Monday-Friday, 8 AM to 8 PM EST Fax: in the US lscainstrumentsales@agilent.com in the US and Canada Online: in the US and Canada Subtotal: Tax: Total: *See page 8 for 708-DS/709-DS configurations and part number tables. *See page 72 for 8000 configurations and part number tables. *See page 84 for online UV System configurations and part number tables

154 Notes 152

155 VISUALIZE DISSOLUTION CAPABILITIES Confidence means getting the right results the first time. Visibility of your dissolution test is critical for getting results you can trust, and the Agilent 709-DS Dissolution Apparatus provides an unobstructed view of the dissolution environment. With its bath-free, open-access design and the latest smart vessel technology, the Agilent 709-DS provides accurate temperature control and reduced preheating time for maximum efficiency, all in a safety-coated vessel. Learn about the Agilent 709-DS at and witness the consistency, reproducibility, and convenience it can bring to your dissolution analysis. Agilent Technolgies Inc. 2011

156 For more information Learn more: Buy online: Find an Agilent customer center in your country: U.S. and Canada Europe Asia Pacific Agilent Technologies, Inc Printed in Germany, October 01, EN