Dissolution and Drug Release Testing -...

Dissolution and Drug Release Testing

DISSOLUTION SYSTEMSSOURCE BOOK 2011-2012 Edition

Welcome

Agilent Technologies, Inc. is well known within the pharmaceutical community for itsbroad portfolio of instruments and supplies, and now offers a variety of dissolution andpharmaceutical testing equipment. Agilent’s unique position as a leader in analyticalinstruments allows us to meet all your needs for equipment, software and reporting packages,qualification documentation and services, training and post-sale support – anywhere youoperate 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 andordering details for thousands of Agilent dissolution products.

Agilent chemists are always available to assist you with dissolution questions. Contact ourDissolution Hotline at [email protected]. More information is available byvisiting www.agilent.com/lifesciences/dissolution or by contacting your local Agilentrepresentative.

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Table of Contents

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12162250545760

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707078798082

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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................................................708-DS and 709-DS Accessories .....................................................................................................Dissolution Accessories.....................................................................................................................Apparatus 3 – BIO-DIS Reciprocating Cylinder Apparatus..............................................................Apparatus 7 – Reciprocating Holder Apparatus 7 ...........................................................................Apparatus 7 – 400-DS Apparatus 7 for Small-volume Dissolution .................................................Rotating Bottle Apparatus ................................................................................................................

Dissolution Software ............................................................................................................................

Calibration and Verification Tools......................................................................................................QAII C Mechanical Qualification Station ..........................................................................................5010 Height/Center Qualification Station ........................................................................................Verification Tools................................................................................................................................

Automated Dissolution Sampling Systems and Accessories .....................................................8000 Dissolution Sampling Station ..................................................................................................806 Syringe Pump ............................................................................................................................808 Filter Changer............................................................................................................................810 Peristaltic Pump.........................................................................................................................8020 Dissolution Sampling/HPLC Injector .......................................................................................

Automated UV Dissolution Systems and Software .......................................................................8453 UV Dissolution Systems...........................................................................................................Cary 60 UV Dissolution Systems.......................................................................................................

Automated HPLC Systems ...................................................................................................................

Physical Testers and Accessories .....................................................................................................100 Automated Disintegration Apparatus........................................................................................200 Hardness Tester .........................................................................................................................250 Friability Tester...........................................................................................................................350 Tapped Density Tester................................................................................................................

Service and Qualification ....................................................................................................................

Educational Services and Industry Support ....................................................................................

Index .........................................................................................................................................................

Part Number Index............................................................................................................................

Alphabetical Index ............................................................................................................................

Ordering Information ............................................................................................................................

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Market Solutions

Market SolutionsAgilent Solutions for the Pharmaceutical Industry

About AgilentAgilent Technologies is the world’s premier measurement company. Through the company’sacquisition of Varian, Inc. in 2010, we expanded our already extensive product portfolio forthe pharmaceutical industry. The former VanKel Technology Group, which Varian acquired in 2001, offered many instruments for testing and evaluating pharmaceutical dosage formsincluding dissolution, disintegration, friability, hardness and tapped density. These productsand 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 andhelped shape the technology industry from what is now Silicon Valley in California. Agilentbegan operating in 1999 as an independent company, but retained the historical HPcommitment to innovation and contribution, uncompromising integrity, teamwork, trust and respect for the individual.

Practical Solutions for Pharmaceutical TestingWith a rich history in supporting the pharmaceutical industry, Agilent offers solutions for drugdiscovery, development and manufacturing. The addition of the dissolution business furthersAgilent’s support of the pharmaceutical industry through a portfolio of leading dissolutioninstrumentation and services. Being part of a company that provides the leading UV-Vis andHPLC solutions to the pharmaceutical industry allows us to offer complete workflow solutions,from dissolution apparatus, sampling devices, analytical instruments and the software tocontrol them.

We manufacture dissolution instrumentation to test nearly every dosage form produced. Ourstaff of application chemists can assist you in selecting the right apparatus and accessories foryour method. Whether in R&D or QA/QC, when it comes to analyzing those samples, we offerindustry 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 methodologyrequire HPLC analysis, we have you covered there as well. The Agilent 1200 LC Series, withits flexible, modular design, ensures configurations ideally suited to meet your applicationrequirements.


Market Solutions

Workflow EnhancementsWe strive to provide solutions for every type of dissolution user, from routine applications toearly 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 shouldyou have questions or require assistance, so you have less downtime and better utilization ofyour equipment.

Quality

The Agilent Service Advantage: Helping You Focus On What You Do Best

Agilent Technologies Quality PolicyAgilent will earn customer loyalty by providing products, services and interactions of thehighest 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 Standardor 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.

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 globalservice centers.

More Than Great Products

At Agilent, we believe that our customers define quality. They do this every day with theproducts and services they purchase. Customers buy based on perceived value – that is, theymeasure the benefits against the costs and select the product and experience that providessuperior value. We, therefore, define quality as customer-perceived value.Agilent products are designed to meet or exceed current published pharmacopeia, as well asFDA and ASTM, requirements at the time of manufacture. Our goal is to supply you with thehighest quality pharmaceutical testing solutions on the market. Our products are manufacturedin Cary, North Carolina at our ISO 9001:2008-certified facility and our Quality managementSystem provides you the assurance that our company has the requisite quality system in placeto support your activities around the globe.

Quality equipment is just onecomponent of your work. We believeeducation is critical to ensuring correctresults. For this reason, we offernumerous educational programs geared to various functions within your company. See page 128 for more information.

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Industry Information



Apparatus, Pharmacopeia and Regulatory Affairs OverviewThe design of dissolution apparatus is specified by the various pharmacopeias from around theworld. 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 goodmanufacturing practices (GMPs).

Agilent’s dissolution apparatus are developed to operate under GMP environments whichrequire installation, operational, and ongoing performance or mechanical qualifications toverify 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 extendedrelease 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 internationalpharmaceutical agencies, visit: www.agilent.com/lifesciences/regulatory_disso

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Applications and Testing Capabilities of Agilent Dissolution Apparatus

Dissolution Apparatus Description Common Products Types

Stirred Vessel Methods – The basket and paddle dissolution apparatus are the most commonly used throughout the world. These methodstraditionally 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-DSDissolution Apparatus for Rotating Basket (USP Apparatus 1)

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 50-100 rpm.

� Capsules� Tablets� Floating dosage forms� Modified release products� Beads� Suppositories

Agilent 708-DS and 709-DSDissolution Apparatus for Rotating Paddle (USP Apparatus 2)

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 50-75 rpm.

� Tablets� Capsules� Hydrogels� Powders� Suspensions� Microparticles

Agilent 708-DS and 709-DSDissolution Apparatus for Paddle over Disk (USP Apparatus 5)

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.

� Transdermal patches

Agilent 708-DS and 709-DSDissolution Apparatus for Rotating Cylinder (USP Apparatus 6)

Rotating dissolution apparatus that utilizes a rotating cylinder upon which a transdermal patch is placed; cylinder provides mixing by convection principles.

� Transdermal patches

Reciprocating Methods – The dosage form is placed within a chamber through which media flows in alternating directions, or on/within numerousholders specifically designed for novel extended release dosage forms. The cylinders or holders typically reciprocate in 300 mL vessels although bothlarger and smaller outer vessels are available.

Agilent BIO-DIS ReciprocatingCylinder Apparatus (USP Apparatus 3)

Mimicking the pH changes of the GI tract, glass cylinders containing thedosage form between capped screens of varying mesh sizes reciprocate 10 cm within 300 mL vessels containing media for a designated time periodbefore the dosage form is transported to another row of media (six rows are available).

� Capsules� Beads� Enteric coated products� Extended, modified or sustained

release formulations

Agilent Reciprocating HolderApparatus and 400-DSDissolution Apparatus (USP Apparatus 7)

Holders designed for sustained or extended release, including small-volumeproducts, reciprocate through a distance of 2 cm in volumes ranging from300 mL to 3 mL per sample row or time point.

� 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 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.

� Pure drug substances

Agilent Enhancer Cell for Diffusion Cells Testing

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.

� Ointments� Creams� Gels� Transdermal

Agilent Peak Vessel The Peak Vessel contains an inverted peak in the base of the vessel to displace exhibiting the unstirred zone, preventing cone formation.

� Beads� Products exhibiting coning

problems

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Dissolution Apparatus and Accessories

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708-DS Dissolution Apparatus

Hands-free evaporation cover suspension supports easymedia addition.

Agilent 708-DS Dissolution Apparatus The 708-DS Dissolution Apparatus provides an ideal platform for laboratories to standardizetheir dissolution testing. This instrument is designed to deliver consistent performance andresults 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 themost demanding laboratory conditions. The intelligent design accommodates all requirementsfrom basic manual testing to automated configurations for high-throughput sampling andonline analysis. The apparatus allows for advanced usage options including automated dosagedelivery, in-vessel temperature monitoring, automated sampling and in situ fiber optic analysis. Providing a new standard for reliability and reproducibility in dissolution testing, the ruggedplatform conforms to either the USP Performance Verification Test (PVT) or the most rigorousenhanced mechanical qualification (MQ) standards as recommended by the ASTM and FDA.The advanced design serves to minimize or eliminate variability, allowing for monitoring subtlechanges attributed to dosage forms, not the dissolution apparatus. In fact, particular attentionwas given to simplifying the measurement of critical parameters, resulting in a smooth andquiet recessed drive unit with unobstructed shaft and vessel access.

• Flexible sampling options: access to all vessels and clearance from the vessel plate ensuresquick, simple manual sampling through the evaporation cover port. Or, automate yoursampling 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 optionalhandheld temperature probe or automate this process with AutoTemp In-vessel TemperatureMonitoring.

• Automate your dosage delivery with the Dosage Delivery Module (DDM), or simply introducesamples by manual insertion through the evaporation cover port. Using the DDM featureallows you to precisely drop samples simultaneously or sequentially at a predeterminedinterval.

• Customize your instrument with interchangeable dissolution accessory components. The common upper shafts support interchangeable baskets and paddles, yet maintain thecorrect height to save time when switching configurations.

• Easily navigate the touch screen panel to setup, store and operate methods on the easy-to-read color display. The intuitive interface with screen-locking security features also offersmultiple 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 automaticallyraise/lower with the apparatus drive unit using either the alignment posts or DDMassemblies.

• Ensure proper vessel alignment with the 708-DS’s TruAlign vessel. The incorporated collarmaintains accurate center and verticality alignment and the indicator tab on the collar offersthe benefit of reproducible orientation.

• Decrease cleaning time with the angled water bath that supports complete draining, andsaves valuable bench space with the integrated, quiet, vibration-isolating heater/circulator.

Apparatus 1, 2, 5, 6 and Intrinsic

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Multicell UV Dissolution System, including the 708-DS Dissolution Apparatus, 810 PeristalticPump, 8000 Dissolution Sampling Station and Cary 60 UV-visible Spectrophotometer

21 CFR Part 11 ComplianceAgilent's Dissolution WorkstationSoftware provides control of up to four dissolution apparatus from one PC.This software can operate any Agilentdissolution apparatus and samplingsystems, as well as systems from Varian and VanKel. See page 62 formore information about the DissolutionWorkstation Software.

Online Dissolution and Analysis

Standard 708-DS ConfigurationBecause the 708-DS is designed for configurability, you have the ability to select the exactoptions 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

Designed with Compliance in MindThe recessed head with unobstructed access on the 708-DS makes setting and verifyingphysical 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, buthas made available a fully enhanced laboratory solution. This includes the traditional AIQcompliance services and documentation consisting of IQ, OQ, PQ and/or MQ. In addition tothese traditional offerings, Agilent provides training and familiarization, SOP templates andguidance, educational seminars, technical and application related support, and much more.

Physical parameter verification on the 708-DS is simpleas illustrated above using the QAII C MechanicalQualification Station to measure RPM and basket wobble.

Did You Know?When recording the physical parametersof the dissolution apparatus, duringMechanical Qualification, for example,it is important to measure parameterswith the actual shafts and vessels usedwhen performing the dissolution tests.Record the accessory serial numbersand position within the apparatus.Agilent's 708-DS and 709-DS do notrequire the use of surrogate shafts orvessels to perform these measurementsduring an OQ, PQ, or MQ.

Modular detection and automation components can easily be integrated to accomplish a UVanalytical finish during dissolution testing. Agilent offers UV Dissolution capabilities with theindustry-leading 8453 UV-visible spectrophotometer, as well as the Cary 60 spectrophotometerwith either multicell or fiber optic configurations. See page 84 for more details.

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708-DS Dissolution Apparatus BundlesDescription Part Number708-DS for manual sampling, without manifold, 6-position 16-6100708-DS for manual sampling, without manifold, 8-position 16-6200708-DS, sampling manifold only, 6-position 16-6300708-DS, sampling manifold only, 8-position 16-6400708-DS, sampling manifold only, 8-position, for online UV 16-6500708-DS, sampling manifold and temperature, 6-position 16-6600708-DS, sampling manifold and temperature, 8-position 16-6700708-DS, sampling manifold and temperature, 8-position, for UV 16-6800708-DS, DDM, sampling manifold and temperature, 6-position 16-6900708-DS, DDM, sampling manifold and temperature, 8-position 16-7000708-DS, DDM, sampling manifold and temperature, 8-position, for UV 16-7100

Bundles are available for the most common 708-DS configurations, and include a standard708-DS with specified features, accessory kits, 1L TruAlign clear vessels and receptor shafts.Paddle shafts, basket shafts and baskets must be ordered separately.

708-DS Dissolution Apparatus Bundles

Dosage Delivery Modules (DDM)

Dosage Delivery ModulesEquip your 708-DS or 709-DS withDDM to simplify dropping your dosageform when using paddles. Methods canbe programmed to automatically startsimultaneously or sequentially. TheDDM option saves analyst time andprevents costly timing errors. Thisfeature is especially valuable whenautomated sampling systems areconfigured.

In addition to the 708-DS bundles, a custom configuration gives you the flexibility to chooseadditional 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

Note: Vessels, paddles, basket shafts and baskets must be ordered separately with customconfigurations. See the example below for accessory ordering information. See page 9 forexamples on ordering a custom configuration, or contact your Agilent representative forordering assistance.

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708-DS Custom Configuration Ordering ExampleQuantity Description1 708-DS, 2L, motorized lift, 6-position K1000-044001 708-DS/709-DS thermal printer assembly K1005-019631 708-DS/709-DS DDM and upper post, 6-position K1005-018731 708-DS sampling and temperature kit, 6-position, 2L K1001-011871 708-DS assembly, common accessories, 1 and 2L, 6-position K1005-018296 Upper receptor shaft, 21 in. 12-14336 Paddle, lower interchangeable, electropolished stainless steel,

for 2L12-1437

6 Basket shaft clip, lower interchangeable, standard USP, for 2L 12-14386 Basket, USP, 40-mesh, 381 µm 12-21006 TruAlign vessel, 2L 12-5157

Non-resident sampling cannulas in a TruAlign vessel onthe 708-DS

To configure a custom 708-DS, select an option from each of the subsections in the CustomConfigurations 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.

Temperature MonitoringVerify and monitor individual vesseltemperatures prior to starting a testwith the AutoTemp option. Once the settemperature is reached, the apparatuscan initiate the test without analystintervention.

Adding Automation or UVDissolution CapabilitiesThe 708-DS Dissolution Apparatus canpair with any Agilent sampling,pumping, filter and UV dissolutioninstruments to create an automatedsolution for your laboratory. See page70 for automated sampling, pumpingand filtering options, and see page 84for automated UV dissolution options.

Dosage Delivery Modules (DDM)

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708-DS Dissolution Apparatus – Custom ConfigurationsDescription Part Number708-DS Dissolution Apparatus – Base UnitChoose one (1) 708-DS base unit from this section708-DS, 1L, manual lift, 6-position K1000-04100708-DS, 1L, manual lift, 8-position K1000-02100708-DS, 1L, motorized lift, 6-position K1000-04200708-DS, 1L, motorized lift, 8-position K1000-02200708-DS, 2L, manual lift, 6-position K1000-04300708-DS, 2L, manual lift, 8-position K1000-02300708-DS, 2L, motorized lift, 6-position K1000-04400708-DS, 2L, motorized lift, 8-position K1000-02400708-DS Dissolution Apparatus – Printer OptionChoose one (1) printer option for the 708-DS708-DS/709-DS thermal printer assembly K1005-01963708-DS/709-DS assembly, without printer K1005-01964708-DS Dissolution Apparatus – DDM OptionChoose one (1) DDM option for the 708-DS708-DS/709-DS, manual kit, without DDM and alignment posts, 6-position K1005-01871708-DS/709-DS, manual kit, without DDM and alignment posts, 8-position K1005-01876708-DS/709-DS alignment post kit, evaporation cover, 6-position K1005-01872708-DS/709-DS alignment post kit, evaporation cover, 8-position K1005-01875708-DS/709-DS DDM and upper post, 6-position K1005-01873708-DS/709-DS DDM and upper post, 8-position K1005-01874708-DS/709-DS DDM and upper post kit, 6-position and alignment kit, 2-position K1005-01987708-DS/709-DS alignment post kit, 7-position, 200 mL standard, for online UV K1005-01989708-DS/709-DS DDM and upper post kit, 6-position, 1 alignment post, 200 mLstandard, for online UV

K1005-01990

708-DS Dissolution Apparatus – Manifold OptionChoose one (1) manifold option for the 708-DS708-DS without manifold kit K1005-01944708-DS temperature kit, 6-position, 1L K1001-01060708-DS temperature kit, 8-position, 1L K1001-01178708-DS sampling kit, 6-position, 1L K1001-01171708-DS sampling kit, 8-position, 1L K1001-01172708-DS sampling and temperature kit, 6-position, 1L K1001-01183708-DS sampling and temperature kit, 8-position, 1L K1001-01184708-DS sampling kit, 1L, 200 mL standard, for online UV K1001-01197708-DS sampling and temperature kit, 1L, 200 mL standard, for online UV K1001-01198

(Continued)

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Hydrodynamic DisturbancesAvoid hydrodynamic disturbancescaused by resident dwelling probes.The sampling manifold only lowers theprobes during sampling – lifting theprobes between timepoints.

708-DS fiber optic kit, 6-position, 1L K1001-01189708-DS fiber optic and temperature kit, 6-position, 1L K1001-01191708-DS temperature kit, 6-position, 2L K1001-01181708-DS temperature kit, 8-position, 2L K1001-01182708-DS sampling kit, 6-position, 2L K1001-01175708-DS sampling kit, 8-position, 2L K1001-01176708-DS sampling and temperature kit, 6-position, 2L K1001-01187708-DS sampling and temperature kit, 8-position, 2L K1001-01188708-DS sampling kit, 2L, 200 mL standard, for online UV K1001-01199708-DS sampling and temperature kit, 2L, 200 mL standard, for online UV K1001-01200708-DS sampling kit, 6-position, 100 and 200 mL K1001-01173708-DS sampling kit, 8-position, 100 and 200 mL K1001-01174708-DS temperature kit, 6-position, 100 and 200 mL K1001-01179708-DS temperature kit, 8-position, 100 and 200 mL K1001-01180708-DS sampling and temperature kit, 6-position, 100 and 200 mL K1001-01185708-DS sampling and temperature kit, 8-position, 100 and 200 mL K1001-01186708-DS fiber optic kit, 6-position, 100 and 200 mL K1001-01190708-DS fiber optic and temperature kit, 6-position, 100 and 200 mL K1001-01192708-DS resident sampling kit, 6-position, 900 mL K1001-01193708-DS resident sampling kit, 8-position, 900 mL K1001-01194708-DS resident sampling kit, 6-position, 500 mL K1001-01195708-DS resident sampling kit, 8-position, 500 mL K1001-01196708-DS Dissolution Apparatus – Temperature ProbeChoose probe for manual temperature monitoring (optional).708-DS vessel temperature probe, handheld K1005-01968708-DS Dissolution Apparatus – Accessory Kit OptionChoose one (1) accessory kit option for the 708-DS708-DS assembly, common accessories, 1 and 2L, 6-position K1005-01829708-DS assembly, common accessories, 1 and 2L, 8-position K1005-01909708-DS assembly, common accessories, 1 and 2L, 8-position, UV K1005-01912708-DS assembly, common accessories, 1 and 2L, 6-position, amber K1005-01915708-DS assembly, common accessories, 1 and 2L, 8-position, amber K1005-01916708-DS assembly, common accessories, 1 and 2L, 8-position, UV, amber K1005-01924708-DS assembly, common accessories, 100 and 200 mL, 6-position, TruAlign K1005-01939708-DS assembly, common accessories, 100 and 200 mL, 8-position, TruAlign K1005-01940

708-DS Dissolution Apparatus – Manifold OptionDescription Part Number

708-DS Dissolution Apparatus – Custom Configurations

708-DS Dissolution Apparatus: 8-position, 2L model withmotorized lift

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Agilent 709-DS Dissolution ApparatusUsing the same platform as the 708-DS, the 709-DS Dissolution Apparatus ensuresproductivity, reproducibility and ease of use combined with the convenience of a bath-freedesign. The 709-DS reduces media heating time with Direct Vessel Heating (DVH) capabilitieswhile insulating the vessel from environmental factors and eliminating water bath cleaning.The exclusive design of the chemically resistant, DVH TruAlign vessel incorporates cutting-edge heat-sensing technology in the vessel wall. The unique clear vessel coating offersprotection 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 criticalcomponent of the dissolution test. The TruAlign vessel collar is fitted in the ground glassgroove to ensure every vessel is perfectly centered and the collar is perpendicular to thevessel walls. The DVH controller resides in the rear of the apparatus and requires noadditional bench space.

• Includes a manifold equipped with AutoTemp In-Vessel Temperature Sensing as standard toensure each vessel temperature is individually measured and recorded prior to and duringthe dissolution run.

• Uses 1L DVH vessels and environmental chambers that prevent temperature fluctuationsfrom external air sources such as air conditioning vents. The chambers also provide anadded 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 andevaporation covers.

Bath-free Advantages: How Does it Work?Each dissolution test performed with the 709-DS involves a preheat cycle to equilibrate vesseltemperature. During this cycle, the DVH vessels are heated as the temperatures are monitoredclosely. Since the traditional dissolution basket, or empty shaft, does not provide a great dealof agitation, a custom replacement basket is used during warm up to reduce equilibrationtime. These attachments are used prior to beginning any basket tests until the set temperatureis 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 10-15 minutes. The combination of DVHtechnology and the electronic intelligence built into the controller provides vessel temperaturestability with unmatched precision.

See the 708-DS and 709-DS inAction!View the electronic demo and find outhow your laboratory can be moreproductive!www.agilent.com/lifesciences/dissolutiondemo

Apparatus 1, 2, 5, 6 and Intrinsic

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Custom basket used for preheating inside a DVH vessel

Standard 709-DS ConfigurationDesigned 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:

• Dosage Delivery Modules (DDM)• Autosampling cannulas• Built-in printer

Items ordered separately:

• Basket / paddle shafts• Baskets or paddles

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709-DS Dissolution Apparatus BundlesBundles are available for the most common 709-DS configurations, and include: a standard709-DS with specified features including AutoTemp, accessory kits, 1L TruAlign DVH vesselsand receptor shafts. Lower interchangeable basket shafts and paddles, and baskets must beordered separately. Custom configurations give you the flexibility to choose additional optionsto 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• Clear or amber environmental chambers• Verified accessories with individual certificates documenting critical dimensions

709-DS Dissolution Apparatus BundlesDescription Part Number709-DS system for manual sampling, temperature only, 6-position 16-7200709-DS system for manual sampling, temperature only, 8-position 16-7300709-DS system, sampling and temperature, 6-position 16-7400709-DS system, sampling and temperature, 8-position 16-7500709-DS system, DDM, sampling and temperature, 6-position 16-7600709-DS system, DDM, sampling and temperature, 8-position 16-7700

709-DS Custom Configuration Ordering ExampleQuantity Description Part Number1 709-DS, with DVH, motorized lift, 6-position K1000-046001 708-DS/709-DS thermal printer assembly K1005-019631 708-DS/709-DS DDM and upper post, 6-position K1005-018731 709-DS, sampling kit, DVH only, 6-position, 1L K1001-011606 709-DS DVH accessory kit, verified DVH vessel, amber

environmental chamberK1001-01131

1 709-DS assembly, common accessories, 1L 6-position, amber K1005-019716 Upper receptor shaft, 21 in., with certificate 12-1433V6 Paddle, lower interchangeable, electropolished stainless steel,

with certificate12-1421V

709-DS with AutoTemp, Autosampling and DDM.

To configure a custom 709-DS, select an option from each of the subsections in the CustomConfigurations 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.

Note: Vessels, paddles, basket shafts and baskets must be ordered separately with customconfigurations. See page 17 for accessory ordering information. See below for an examplecustom configuration or contact your Agilent representative for ordering assistance.

15



709-DS Dissolution Apparatus – Custom ConfigurationsDescription Part Number709-DS Dissolution Apparatus – Base UnitChoose one (1) 709-DS base unit from this section709-DS, with DVH, motorized lift, 6-position K1000-04600709-DS, with DVH, motorized lift, 8-position K1000-02600709-DS Dissolution Apparatus – Printer OptionChoose one (1) printer option for the 709-DS708-DS/709-DS thermal printer assembly K1005-01963708-DS/709-DS assembly, without printer K1005-01964709-DS Dissolution Apparatus – DDM OptionChoose one (1) DDM option for the 709-DS708-DS/709-DS, manual kit, without DDM and alignment posts, 6-position K1005-01871708-DS/709-DS, manual kit, without DDM and alignment posts, 8-position K1005-01876708-DS/709-DS alignment post kit, evaporation cover, 6-position K1005-01872708-DS/709-DS alignment post kit, evaporation cover, 8-position K1005-01875708-DS/709-DS DDM and upper post, 6-position K1005-01873708-DS/709-DS DDM and upper post, 8-position K1005-01874708-DS/709-DS DDM and upper post kit, 6-position and alignment kit, 2-position, for UV dissolution

K1005-01987

709-DS Dissolution Apparatus – Manifold Option Choose one (1) sampling kit for automated sampling (optional)709-DS, sample tubing, DVH only, 6-position, 1L K1001-01160709-DS, sample tubing, DVH only, 8-position, 1L K1001-01161709-DS Dissolution Apparatus – Vessel Accessory Kit OptionChoose the preferred vessel accessory kit for the 709-DS – items sold individually, select appropriate quantity709-DS DVH accessory kit, DVH vessel, clear environmental chamber K1001-01128709-DS DVH accessory kit, verified DVH vessel, clear environmental chamber K1001-01129709-DS DVH accessory kit, DVH vessel, amber environmental chamber K1001-01130709-DS DVH accessory kit, verified DVH vessel, amber environmental chamber K1001-01131709-DS Dissolution Apparatus – Accessory Kit OptionChoose one (1) standard accessory kit for the 709-DS709-DS assembly, common accessories, 1L, 8-position K1005-02009709-DS assembly, common accessories, 1L, 8-position, amber K1005-02010

709-DS DVH vessel

Adding Automation or UVDissolution CapabilitiesThe 709-DS Dissolution Apparatus can pair with any Agilent sampling,pumping, filter and UV dissolutioninstruments to create an automatedsolution for your laboratory. See page 70 for automated sampling,pumping and filtering options, and see page 84 for automated UVdissolution options.

16



Two-piece interchangeable paddle/basket shafts with 40-mesh baskets

(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

708-DS and 709-DS Accessories

Baskets, Paddles and ShaftsFor Apparatus 1 (baskets) and Apparatus 2 (paddles) dissolution testing, Agilent’s variety ofquality accessories can support your laboratory’s needs while maintaining compliance withregulatory standards.

Two-piece Interchangeable Paddle/Basket ShaftsSwitching between paddles and baskets is simple with Agilent’s two-piece interchangeablepaddle/basket shafts. Rather than resetting the height of the individual shafts when youchange between paddles and baskets, the upper receptor shaft stays securely in place, whilethe lower interchangeable paddle or basket shaft can be switched for your specific testingneeds. The paddle and basket shaft assemblies are designed with height offsets so that theproper height is maintained after the changeover.

These shafts are manufactured to meet or exceed the USP specifications and preciselyengineered, 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 forcontamination and corrosion. Further, each component is serialized for traceability.

For paddle and basket information and ordering details, see page 24.

Did You Know?Agilent provides Verified DissolutionAccessories with individual certificatesof conformance (COCs) that documentactual measured values of all criticaldimensions, the measurement deviceused for certification and its traceability.A wide variety of Verified Accessoriesare available, including various paddles,baskets, basket shafts, and vessels to meet your needs for MechanicalQualification. Verified accessories aredenoted with a “V” at the end of thepart 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.

17



Upper shaft receptor and lower paddle piece

708-DS/709-DS Accessories – Paddles, Basket Shafts and BasketsDescription Part NumberTwo-piece Interchangeable Paddle/Basket ShaftsUpper Receptor ShaftsUpper receptor shaft, 21 in. 12-1433Upper receptor shaft, 21 in., with certificate 12-1433VLower Interchangeable Paddle and Basket ShaftsPaddle, lower interchangeable, Teflon-coated 12-1420Paddle, lower interchangeable, Teflon-coated, with certificate 12-1420VPaddle, lower interchangeable, electropolished stainless steel 12-1421Paddle, lower interchangeable, electropolished stainless steel, with certificate 12-1421VBasket shaft, lower interchangeable, 3-clip, USP 12-1430Basket shaft, lower interchangeable, 3-clip, USP, with certificate 12-1430VBasket shaft, lower interchangeable, O-ring 12-1431Basket shaft, lower interchangeable, Zymark type, conical 12-1432Paddle, lower interchangeable, Teflon-coated, for 2L 12-1436Paddle, lower interchangeable, Teflon-coated, for 2L, with certificate 12-1436VPaddle, lower interchangeable, electropolished stainless steel, for 2L 12-1437Paddle, lower interchangeable, electropolished stainless steel, for 2L, with certificate

12-1437V

Basket shaft 3-clip, lower interchangeable, USP, for 2L 12-1438Basket shaft 3-clip, lower interchangeable, USP, for 2L, with certificate 12-1438VBasket shaft, lower interchangeable, O-ring, for 2L 12-1439Paddle, lower interchangeable, PEEK 12-1440Mini basket, lower interchangeable, Durafit, stainless steel, O-ring 12-1441Mini paddle, lower interchangeable, Teflon-coated 12-1442Mini paddle, lower interchangeable, electropolished stainless steel 12-1443BasketsBasket, USP, 40-mesh, 381 µm 12-2100Basket, USP, 40-mesh, 381 µm, with certificate 12-2100VBasket, mini, 40-mesh, 381 µm 12-2102Basket, 3-fin assembly, 40-mesh, 381 µm 12-2115Basket, 3-fin assembly, 20-mesh, 864 µm 12-2116Basket, 30x30-mesh, 533 µm 12-2160

18



1L TruAlign vessel

Vessels for 708-DS and 709-DSAgilent’s TruAlign vessels for the 708-DS precisely align the vessel every time. Only TruAlignvessels have a collar incorporated onto the vessel around the ground glass grove, maintainingaccurate centering and verticality alignment with the dissolution apparatus. An indicator tabon the collar provides reproducible vessel orientation while the serial number offers easyidentification.Using TruAlign vessel design with the fitted collar, the TruAlign DVH Vessels for the 709-DSalso incorporate cutting-edge heat-sensing technology in the vessel wall. In addition, theheating element is fused to the glass for accelerated heating. The unique clear vessel coatingoffers protection for less breakage, ensuring long-lasting, durable performance. The coatingallows complete visibility of the dosage form within the vessel – a critical component of thedissolution test.

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 sensitiveproducts.

The 708-DS Dissolution Apparatus can also be used with a conversion kit for small-volumedissolution. Each position will require a conversion kit to hold the 100 or 200 mL vessel inposition, and are designed to be used with either mini paddles or mini baskets, which are soldseparately.

Special conversion kits, available in sets of 6 and 8, are also available for the ChinesePharmacopeia (CP) 250 mL vessel. These kits include the 250 mL vessel designed accordingto CP specifications, vessel adapter ring, two-piece mini paddle, evaporation cover andmanifold conversion block.

Conversion Kits

200 mL Conversion Kit

19



(Left to right) 1L TruAlign vessel, 1L amber TruAlignvessel, 2L TruAlign vessel and 200 mL TruAlign vessel

708-DS/709-DS Accessories – Vessels and Conversion KitsDescription Part NumberTruAlign Vessels for 708-DS Dissolution ApparatusTruAlign vessel, 100 mL 12-5145TruAlign vessel, amber, 100 mL 12-5146TruAlign vessel, 200 mL 12-5147TruAlign vessel, amber, 200 mL 12-5148TruAlign vessel, 250 mL, for Chinese Pharmacopeia 12-1452TruAlign vessel, 1L 12-5149TruAlign vessel, 1L, with certificate 12-5149VTruAlign vessel, amber, 1L 12-5152TruAlign vessel, amber, 1L, with certificate 12-5152VTruAlign Peak vessel, 1L 12-5153TruAlign Peak vessel, amber, 1L 12-5154TruAlign vessel, 2L 12-5157TruAlign vessel, 2L, with certificate 12-5157VTruAlign vessel, amber, 2L 12-5158TruAlign vessel, amber, 2L, with certificate 12-5158VTruAlign Peak vessel, 2L 12-5159TruAlign vessel, flat bottom, 200 mL 12-5170TruAlign DVH Vessels for 709-DS Dissolution ApparatusTruAlign vessel, DVH, with collar, 1L 12-1500TruAlign vessel, DVH, with collar, 1L, with certificate 12-1500VTruAlign Vessel Conversion Kit for 708-DS Dissolution ApparatusTruAlign vessel 100/200 mL conversion kit (includes vessel adapter andevaporation cover)

12-6368

TruAlign vessel, 250 mL conversion kit, for CP (includes vessel, adapter, two-piece mini paddle, evaporation cover and manifold adapter), set of 6

12-1450

TruAlign vessel, 250 mL conversion kit, for CP (includes vessel, adapter, two-piece mini paddle, evaporation cover and manifold adapter), set of 8

12-1451

Did You Know?A 708-DS Dissolution Apparatus caneasily convert to a small-volumeapparatus. For example, to convert a 6-position, 1L 708-DS for 200 mLtesting, simply order the parts in thetable on the right.

Small-volume Conversion Ordering ExampleQuantity Description Part Number6 TruAlign vessel, 200 mL 12-51476 TruAlign vessel 100/200 mL conversion kit

(includes vessel adapter and evaporation cover)12-6368

20



Manual temperature measurement using 708-DStemperature probe

708-DS and 709-DS AccessoriesIn addition to vessels, paddles, baskets and shafts, Agilent offers a variety of accessoriesspecific to the 708-DS and 709-DS platform. These accessories include replacement tubingassemblies for sampling and return cannulas, sampling and resident probe sampling manifoldkits, evaporation covers and more.

Adapting to Changing NeedsHave your laboratory needs changed?Are you ready to upgrade to anautomated sampling system? To addsampling capabilities to your 708-DS or 709-DS choose the SamplingManifold Kit that best fits your needsbased on features and vessel volume.Each kit comes with a samplingmanifold, an internal drive assembly,and the features specified in thedescription. Contact your Agilentrepresentative about schedulinginstallation of these items:www.agilent.com/chem/contact

(Continued)

708-DS and 709-DS AccessoriesDescription Part NumberReplacement Tubing Assemblies for 708-DS ManifoldIncludes color-coded sets of tubingTubing assembly, for 1L 708-DS, sample and return cannulas, 6-position 1005-1920Tubing assembly, for 1L 708-DS, sample and return cannulas, 8-position 1005-1921Tubing assembly, for 2L 708-DS, sample and return cannulas, 6-position 1005-1922Tubing assembly, for 2L 708-DS, sample and return cannulas, 8-position 1005-1923Sampling Manifold Kits for 708-DS and 709-DSIncludes manifold, internal drive assembly and other listed features.708-DS sampling kit, 6-position, 1L K1001-01171708-DS sampling kit, 8-position, 1L K1001-01172708-DS sampling kit, 6-position, 100 and 200 mL K1001-01173708-DS sampling kit, 8-position, 100 and 200 mL K1001-01174708-DS sampling kit, 6-position, 2L K1001-01175708-DS sampling kit, 8-position, 2L K1001-01176708-DS temperature kit, 6-position, 1L K1001-01177708-DS temperature kit, 8-position, 1L K1001-01178708-DS temperature kit, 6-position, 100 and 200 mL K1001-01179708-DS temperature kit, 8-position, 100 and 200 mL K1001-01180708-DS temperature kit, 6-position, 2L K1001-01181708-DS temperature kit, 8-position, 2L K1001-01182708-DS sampling and temperature kit, 6-position, 1L K1001-01183708-DS sampling and temperature kit, 8-position, 1L K1001-01184708-DS sampling and temperature kit, 6-position, 100 and 200 mL K1001-01185708-DS sampling and temperature kit, 8-position, 100 and 200 mL K1001-01186708-DS sampling and temperature kit, 6-position, 2L K1001-01187708-DS sampling and temperature kit, 8-position, 2L K1001-01188708-DS fiber optic kit, 6-position, 1L K1001-01189708-DS fiber optic kit, 6-position, 100 and 200 mL K1001-01190708-DS fiber optic and temperature kit, 6-position, 1L K1001-01191708-DS fiber optic and temperature kit, 6-position, 100 and 200 mL K1001-01192708-DS sampling kit, 1L, 200 mL standard, for online UV K1001-01197708-DS sampling and temperature kit, 1L, 200 mL standard, for online UV K1001-01198708-DS sampling kit, 2L, 200 mL standard, for online UV K1001-01199708-DS sampling and temperature kit, 2L, 200 mL standard, for online UV K1001-01200

21



Two-piece interchangeable basket/paddle shaft storage rack

Acrylic rinse tray

Sampling Manifold Kits for 708-DS and 709-DSIncludes manifold, internal drive assembly and other listed features.709-DS, sample tubing, DVH only, 6-position, 1L K1001-01160709-DS, sample tubing, DVH only, 8-position, 1L K1001-01161Resident Probe Sampling Kits for 708-DS708-DS resident sampling kit, 6-position, 900 mL K1001-01193708-DS resident sampling kit, 8-position, 900 mL K1001-01194708-DS resident sampling kit, 6-position, 500 mL K1001-01195708-DS resident sampling kit, 8-position, 500 mL K1001-01196

708-DS/709-DS evaporation cover, low-loss seal 1005-1812708-DS/709-DS evaporation cover, standard seal 1005-1813708-DS/709-DS evaporation cover, low-loss seal, amber 1005-1899708-DS/709-DS evaporation cover, standard seal, amber 1005-1900708-DS/709-DS evaporation cover retainer post, for use in place of DDM 1005-1898708-DS/709-DS evaporation cover plug, white, for use in place of DDM 1200-1012

708-DS and 709-DS AccessoriesDescription Part Number

Evaporation Covers and Accessories for 708-DS and 709-DS

708-DS/709-DS evaporation cover plug, black, fingertip, for alternative sample opening

12-6365

708-DS/709-DS evaporation cover plug, black, fingertip, for alternative sample opening, 6/pkg.

12-6370

Miscellaneous Accessories for 708-DS and 709-DSHeater/Circulator, with Wide Input Range Heater, 115/230V 65-3850Water bath temperature probe 67-0300708-DS vessel temperature probe handheld K1005-01568DDM assembly, for use with 708-DS and 709-DS (sold separately) 1005-1897708-DS/709-DS thermal printer assembly K1005-01963Thermal printer paper, for use with 708-DS and 709-DS, 10 rolls/pkg. 12-9988Thermal printer paper, for use with 708-DS and 709-DS, 100 rolls/pkg. 12-9989Cannula rinse cup, with shaft clip 17-1340Cannula rinse cup carrying tray 17-1345Acrylic rinse tray, for 708-DS/709-DS 17-1351Storage rack, two-piece interchangeable basket/paddle shaft 12-1352

22


www.agilent.com/lifesciences/dissolutionaccessories

Dissolution Accessories

Baskets, Paddles and ShaftsFor Apparatus 1 (baskets) and Apparatus 2 (paddles) dissolution testing, Agilent’s variety ofquality accessories can support your laboratory’s needs while maintaining compliance withregulatory standards. In keeping with the most current guidance for mechanical qualification,Agilent also offers Verified Dissolution Accessories including baskets, paddles and shafts withcertificates of conformity with actual component measurements for all critical dimensionsusing traceable devices.

Basket ShaftsWhether you need electropolished stainless steel, Teflon-coated, gold-plated or Durafit basketshafts, Agilent provides these individually serialized accessories. Basket shaft options include3-clip shafts to meet standard USP design, O-ring for automated systems, or conical surface tosupport air bubble dispersion. A range of basket shaft sizes from 14.5 in. for the discontinued7025/7030 apparatus to 24 in. for large volume discontinued 7000/7010 instruments areoffered.

BasketsFrom the standard USP 40-mesh stainless steel basket, to custom baskets with varying meshsizes, to baskets specific to small or large dosage forms, Agilent supports your Apparatus 1needs. Unless otherwise noted, all baskets fit the standard basket shafts.

PaddlesOne-piece paddles are serialized and designed to meet USP specifications for Apparatus 2.Select from electropolished stainless steel, Teflon-coated or the biocompatible, chemically inertPEEK (polyetheretherketone) paddles in a range of sizes. Additionally, mini and mega paddlesfor small- and large-volume dissolution testing are available.

Two-piece Interchangeable Paddle/Basket ShaftsSwitching between paddles and baskets is simple with Agilent’s two-piece interchangeablepaddle/basket shafts. Rather than resetting the height of the individual shafts when youchange between paddles and baskets, the upper receptor shaft stays securely in place, whilethe lower interchangeable paddle or basket shaft can be switched for your specific testingneeds. The paddle and basket shaft assemblies are designed with height offsets so that theproper height is maintained after the changeover.

These shafts are manufactured to meet or exceed the USP specifications and preciselyengineered, 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 forcontamination and corrosion. Further, each component is serialized for traceability.

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.Upper shaft receptor and lower interchangeable paddle

piece

(Right to left) Electropolished stainless steel paddle,Teflon-coated paddle, PEEK paddle, electropolished minipaddle, and Teflon-coated mini paddle

23



(Right to left) Standard 3-clip shaft, conical 3-clip shaft,standard O-ring shaft, conical O-ring shaft, Teflon-coated3-clip shaft, gold-plated 3-clip shaft and mini shaft

Close up of standard 3-clip shaft and conical 3-clip shaft

(Continued)

Basket Shafts / AssembliesDescription Part Number15 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 12-2000Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 15 in. shaft,with certificate

12-2000V

Basket shaft assembly, conical, includes 40-mesh basket, 15 in. shaft 12-2010Basket shaft assembly, Teflon-coated, includes 40-mesh basket, 15 in. shaft 12-2030Basket shaft, O-ring, Durafit, 15 in. 12-2040Basket shaft, O-ring, Durafit, conical, 15 in. 12-2050Basket shaft assembly, Durafit, includes 40-mesh mini basket, 15 in. shaft 12-2057Basket shaft, USP 3-clip, 15 in. 12-2070Basket shaft, USP 3-clip, 15 in., with certificate 12-2070VBasket shaft, conical, 15 in. 12-2075Basket shaft, mini, Durafit, 15 in. 12-2077Basket shaft, mini, Durafit, for 3/8 in. drive, 15 in. 12-2078Basket shaft, gold-plated lower 6 in., 3-clip, 15 in. 12-2085Basket shaft, Teflon-coated, 3-clip, 15 in. 12-2090Basket shaft, Durafit, Teflon-coated, 15 in. 12-2093Basket shaft, for bolus basket, 15 in. 12-209714.5 in. (37 cm) Basket Shafts for 7025/7030Basket shaft, USP, Teflon-coated, for 7025/7030 12-2041Basket shaft, USP, Teflon-coated, for 7025/7030, with certificate 12-2041VBasket shaft, conical, Teflon-coated, for 7025/7030 12-2042Basket shaft, Durafit, Teflon-coated, for 7025/7030 12-2043Basket shaft, Durafit, conical, Teflon-coated, for 7025/7030 12-2044Basket shaft, Durafit, for 7025/7030 12-2045Basket shaft, Durafit, conical, for 7025/7030 12-2053Basket shaft, USP, for 7025/7030 12-2073Basket shaft, USP, for 7025/7030, with certificate 12-2073VBasket shaft, conical, for 7025/7030 12-2076Basket shaft, mini, Durafit, for 7025/7030 12-207919 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 12-2020Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 19 in. shaft,with certificate

12-2020V

Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 24 in. shaft 12-2025Basket shaft assembly, includes 40-mesh basket, USP 3-clip, 24 in. shaft,with certificate

12-2025V

Basket shaft, Durafit, 19 in. 12-2055Basket shaft, Durafit, conical, 19 in. 12-2056Basket shaft, USP 3-clip, 19 in. 12-2080Basket shaft, USP 3-clip, 19 in., with certificate 12-2080VBasket shaft, conical, 19 in. 12-2081Basket shaft, gold-plated lower 6 in., 19 in. 12-2086

24



Basket shaft, 3-clip, Teflon-coated, 19 in. 12-2091Basket shaft, USP 3-clip, 24 in. 12-2095Basket shaft, USP 3-clip, 24 in., with certificate 12-2095VBasket shaft, for bolus basket, 24 in. 12-2098BasketsBasket, USP, 40-mesh, 381 µm 12-2100Basket, USP, 40-mesh, 381 µm, with certificate 12-2100VMini basket only, 20-mesh, 381 µm 12-2102Mini basket only, 40-mesh, 381 µm, with certificate 12-2102VMini basket only, 20-mesh, 864 µm 12-2103Mini basket only, 10-mesh, 1905 µm 12-2104Basket, gold plated, 40-mesh, 381 µm 12-2105Basket, Teflon-coated, 40-mesh 12-2110Basket, 3-fin assembly, 40-mesh, 381 µm 12-2115Basket, 3-fin assembly, 20-mesh, 864 µm 12-2116Basket, 20-mesh, 864 µm 12-2120Basket, 20-mesh, 864 µm, with certificate 12-2120VBasket, 10-mesh, 1905 µm 12-2125Basket, slotted, for suppository testing 12-2130Basket, 450x2750-mesh, 1 µm 12-2140Basket, 400x2800-mesh, 2 µm 12-2145Basket, 325x2300-mesh, 5 µm 12-2146Basket, 200x1400-mesh, 10 µm 12-2148Basket, 165x800-mesh, 20 µm 12-2149Basket, 325x325-mesh, 43 µm 12-2150Basket, 270x270-mesh, 53 µm 12-2151Basket, 150x150-mesh, 104 µm 12-2152Basket, 100x100-mesh, 140 µm 12-2154Basket, 50x50-mesh, 280 µm 12-2155Basket, 30x30-mesh, 533 µm 12-2160Bolus basket, 20x20-mesh, 864 µm 12-2180Bolus basket, 40x40-mesh, 381 µm 12-2185Stationary Baskets and Shafts

Stationary basket and shaft, 20-mesh 12-2060Stationary basket and shaft, 10-mesh 12-2061Stationary basket and shaft, 1 µm 12-2062Stationary basket and shaft, 40-mesh 12-2063Stationary basket and shaft, 100-mesh, 140 µm 12-2064Stationary basket, Felodipine quadrangular 12-2069

19 and 24 in. (48 and 61 cm) Basket Shafts and Assemblies for 705-DS, 7000/7010E (O-ring spindle assembly)

Description Part Number

Basket Shafts / Assemblies

(Left to right) 40-mesh basket, Teflon-coated basket andgold-plated basket

25



Apparatus and One-piecePaddle Compatibility

Paddles14.5 in. 15 in. 19 in. 24 in.

Appa

ratu

s

7025 7000* 705-DS 705-DS7030 7010* 7000** 708-DS

7010** 709-DS7000**7010**

*Chuck/collet spindle assembly**O-ring spindle assembly

Electropolished stainless steel paddle

Paddle ShaftsDescription Part Number15 in. (38 cm) Paddle Shafts for 7000/7010 (chuck/collet spindle assembly)Paddle, Teflon-coated, 15 in. 12-1000Paddle, Teflon-coated, 15 in., with certificate 12-1000VPaddle, electropolished, stainless steel, 15 in. 12-1030Paddle, electropolished stainless steel, 15 in., with certificate 12-1030VPaddle, Dura-Tef, 15 in. 12-1200Paddle, PEEK, 15 in. 12-1201Paddle, PEEK, 15 in., with certificate 12-1201VPaddle, Teflon-coated, 1/4 in. shaft, 200 mL 12-1300Paddle, Teflon-coated, 3/8 in. shaft tapered to 1/4 in., 200 mL 12-1305Paddle, electropolished stainless steel, 1/4 in. shaft, 200 mL 12-1310Paddle, electropolished stainless steel, 3/8 in. shaft tapered to 1/4 in., 200 mL 12-131514.5 in. (37 cm) Paddle Shafts for 7025/7030Paddle, Teflon-coated, for 7025/7030 12-1005Paddle, Teflon-coated, for 7025/7030, with certificate 12-1005VPaddle, electropolished stainless steel, for 7025/7030 12-1035Paddle, electropolished stainless steel, for 7025/7030, with certificate 12-1035VPaddle, PEEK, for 7025/7030 12-1205Paddle, Teflon-coated, 200 mL, for 7025/7030 12-1228Paddle, Teflon-coated, 200 mL, for 7025/7030, with certificate 12-1228VPaddle, electropolished stainless steel, 200 mL, for 7025/7030 12-122919 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. 12-1010Paddle, Teflon-coated, 19 in., with certificate 12-1010VPaddle, Teflon-coated, 24 in. 12-1015Paddle, Teflon-coated, 24 in., with certificate 12-1015VPaddle, electropolished stainless steel, 19 in. 12-1040Paddle, electropolished stainless steel, 19 in., with certificate 12-1040VPaddle, electropolished stainless steel, 24 in. 12-1045Paddle, electropolished stainless steel, 24 in., with certificate 12-1045VPaddle, PEEK, 19 in. 12-1211Paddle, PEEK, 19 in., with certificate 12-1211VPaddle, PEEK, 24 in. 12-1216Paddle, PEEK, 24 in., with certificate 12-1216VPaddle, Teflon-coated, for 3/8 in. drive, 200 mL, 19 in. 12-1306Paddle, Teflon-coated, for 3/8 in. drive, 200 mL, 24 in. 12-1307Paddle, electropolished stainless steel, for 3/8 in. drive, 200 mL, 19 in. 12-1316Paddle, electropolished stainless steel, for 3/8 in. drive, 200 mL, 24 in. 12-1317Mega paddle, 24 in. shaft 12-1318

26



Paddle support rack

Two-piece Interchangeable Paddle/Basket shaftsDescription Part NumberTwo-piece Interchangeable Paddle/Basket ShaftsPaddle, lower interchangeable, Teflon-coated 12-1420Paddle, lower interchangeable, Teflon-coated, with certificate 12-1420VPaddle, lower interchangeable, electropolished stainless steel 12-1421Paddle, lower interchangeable, electropolished stainless steel, with certificate 12-1421VBasket shaft, lower interchangeable, 3-clip, USP 12-1430Basket shaft, lower interchangeable, 3-clip, USP, with certificate 12-1430VBasket shaft, lower interchangeable, O-ring 12-1431Basket shaft, lower interchangeable, O-ring, with certificate 12-1431VBasket shaft, lower interchangeable, Zymark type, conical 12-1432Upper receptor shaft, 21 in. 12-1433Upper receptor shaft, 21 in., with certificate 12-1433VPaddle, lower interchangeable, Teflon-coated, for 2L 12-1436Paddle, lower interchangeable, Teflon-coated, for 2L, with certificate 12-1436VPaddle, lower interchangeable, electropolished stainless steel, for 2L 12-1437Paddle, lower interchangeable, electropolished stainless steel, for 2L, with certificate

12-1437V

Basket shaft clip, lower interchangeable, standard USP, for 2L 12-1438Basket shaft clip, lower interchangeable, standard USP, for 2L, with certificate 12-1438VBasket shaft, lower interchangeable, O-ring, for 2L 12-1439Basket shaft, lower interchangeable, O-ring, for 2L, with certificate 12-1439VPaddle, lower interchangeable, PEEK 12-1440Mini basket, lower interchangeable, Durafit, stainless steel, O-ring 12-1441Mini basket, lower interchangeable, Durafit, stainless steel, O-ring, with certificate

12-1441V

Mini paddle, lower interchangeable, Teflon-coated 12-1442Mini paddle, lower interchangeable, Teflon-coated, with certificate 12-1442VMini paddle, lower interchangeable, electropolished stainless steel 12-1443Mini paddle, lower interchangeable, electropolished stainless steel, with certificate

12-1443V

Shaft AccessoriesCollet, for 3/8 in. dia. shafts 12-1320Collet, for 1/4 in. dia. shafts 12-1330Paddle basket support rack 12-1350Shaft locking ring, for 705-DS, 708-DS, 709-DS, 7025/7030 12-2096Basket and paddle shaft locking rings, 6/pkg. 12-2099

27



TruAlign vessel for the 708-DS

Dissolution Vessels

Agilent provides a variety of dissolution vessels for use with Agilent dissolution apparatus, aswell as other equipment manufacturers. A wide variety of vessel types, volume sizes, typesand collar attachments are available. Agilent's vessels are designed and manufactured tospecification, ensuring quality and consistency.

EaseAlign VesselsEaseAlign vessels are designed to be used on the discontinued 705-DS, 7000 and 7010dissolution 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 andsizes.

TruCenter VesselsUsed with the 7025 and 7030 Dissolution Apparatus, TruCenter vessels offer superiorcentering and vessel verticality and are turned on a lathe during manufacture to find the exactcenter. The vessels incorporate a groove and synthetic flange with magnetic collar to align onthe vessel plate. The magnetic closure on the vessel plate makes inserting or removing avessel simple.In addition to not floating when empty, an added benefit of the TruCenter vessel is the plasticcollar 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 TruCentervessels (see page 30).

TruAlign VesselsVerified DissolutionAccessoriesDo you need vessels that are certifiedfor conformance with MechanicalQualification guidelines? Agilent offers Verified Dissolution Accessorieswith a certificate of conformance that documents the actual measuredvalues of all critical dimensions, the measurement device used forcertification, and its traceability. Verified accessories are denoted with a “V” at the end of the part number.

The TruAlign vessels for the 708-DS and 709-DS have a collar incorporated onto the vessel tomaintain accurate centering and verticality alignment with the dissolution apparatus. Anindicator tab on the collar provides reproducible vessel orientation while the serial numberoffers easy identification.The TruAlign DVH Vessel for the 709-DS also incorporates cutting-edge heat-sensingtechnology in the vessel wall. The unique clear vessel coating offers protection for lessbreakage and complete visibility of the dosage form within the vessel – a critical componentof 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 isavailable in a 1L size only, and amber environmental chambers and evaporation covers areavailable for light sensitive products.

28



EaseAlign Vessels for 705-DS and 7000/7010 Dissolution ApparatusDescription Part NumberEaseAlign vessel, 1L 12-5000EaseAlign vessel, 1L, with certificate 12-5000VEaseAlign vessel, amber, 1L 12-5010EaseAlign vessel, amber, 1L, with certificate 12-5010VEaseAlign vessel, 100 mL 12-5040EaseAlign vessel, amber, 100 mL 12-5041EaseAlign vessel, 200 mL 12-5050EaseAlign vessel, amber, 200 mL 12-5051EaseAlign vessel, flat bottom for Enhancer Cell, 200 mL 12-5055EaseAlign vessel, amber, 500 mL 12-5065EaseAlign vessel, 2L 12-5070EaseAlign vessel, 2L, with certificate 12-5070VEaseAlign vessel, amber, 2L 12-5075EaseAlign vessel, clear plastic, 1L 12-5200EaseAlign vessel, clear plastic, 1L, with certificate 12-5200VEaseAlign Peak vessel, 1L 12-5500EaseAlign Peak vessel, 2L 12-5510EaseAlign Peak vessel, amber, 1L 12-5505

TruCenter Vessels for 7025 and 7030 Dissolution ApparatusDescription Part NumberTruCenter Vessels for 7025 Dissolution ApparatusTruCenter vessel, without collar, 200 mL 12-5033TruCenter vessel, with collar, 200 mL 12-5034TruCenter vessel, with collar, 1L 12-5035TruCenter vessel, with collar, 1L, with certificate 12-5035VTruCenter vessel, amber, with collar, 1L 12-5120TruCenter vessel, amber, with collar, 1L, with certificate 12-5120VTruCenter Peak vessel, with collar, 1L 12-5125TruCenter Peak vessel, amber, with collar, 1L 12-5130TruCenter DVH Vessels for 7030 Dissolution ApparatusTruCenter vessel, DVH, for 7030 only, 1L 12-5039TruCenter vessel, DVH, for 7030 only, 1L, with certificate 12-5039V

Did You Know?A leading cause of failure of the USPPerformance Verification Test (PVT) isvessel variability. To reduce %CV duringthis test, it is beneficial to utilize Agilentvessels. To learn more, visitwww.agilent.com/lifesciences/PVTwhitepaper

1L EaseAlign vessel and 1L TruCenter vessel

29



TruAlign Vessels for 708-DS and 709-DSDescription Part NumberTruAlign Vessels for 708-DS Dissolution ApparatusTruAlign vessel, 100 mL 12-5145TruAlign vessel, amber, 100 mL 12-5146TruAlign vessel, 200 mL 12-5147TruAlign vessel, amber, 200 mL 12-5148TruAlign vessel, 250 mL, for Chinese Pharmacopeia 12-1452TruAlign vessel, 1L 12-5149TruAlign vessel, 1L, with certificate 12-5149VTruAlign vessel, amber, 1L 12-5152TruAlign vessel, amber, 1L, with certificate 12-5152VTruAlign Peak vessel, 1L 12-5153TruAlign Peak vessel, amber, 1L 12-5154TruAlign vessel, 2L 12-5157TruAlign vessel, 2L, with certificate 12-5157VTruAlign vessel, amber, 2L 12-5158TruAlign vessel, amber, 2L, with certificate 12-5158VTruAlign Peak vessel, 2L 12-5159TruAlign vessel, flat bottom, 200 mL 12-5170TruAlign DVH Vessels for 709-DS Dissolution ApparatusTruAlign vessel, DVH, with collar, 1L 12-1500TruAlign vessel, DVH, with collar, 1L, with certificate 12-1500VTruAlign Vessel Conversion Kit for 708-DS Dissolution ApparatusTruAlign vessel 100/200 mL conversion kit (includes vessel adapter and evaporation cover)

12-6368

TruAlign vessel, 250 mL conversion kit, for CP (includes vessel, adapter, two-piecemini paddle, evaporation cover and manifold adapter), set of 6

12-1450


12-1451

1L TruAlign Peak vessel

30



200 mL Conversion Kit

Conversion KitsSmall-volume conversion kits are an excellent, cost-effective way to use your existingequipment 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, whichare sold separately.100 and 200 mL conversion kits are available for the 708-DS, as well as the discontinued705-DS, 7000/7010, and 7025 Dissolution Apparatus. Note that if you intend to useautomated 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-DSDissolution Apparatus and allow you to work with larger media volumes for your dissolutiontesting.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 numberdescriptions.

Large-volume conversion kits include:• 2L vessels• Apparatus leg extenders• Extra-deep water bath• Vessel plate system

TruCenter Conversion

Large-volume Kits

Small-volume Kits

19 or 24 in. paddles and basket shafts are required for large-volume conversion kits and soldseparately. See page 23 for ordering information.

• 1L TruCenter vessel• Adapter ring• Evaporation cover

TruCenter vessels, standard on the 7025 Dissolution Apparatus, offer superior centering andvessel verticality compared to EaseAlign vessels. Conversion kits are available to upgrade your705-DS and 7000/7010 models to TruCenter vessels. The TruCenter kit includes:

31



200 mL glass vessel used in conversion kits

TruCenter Conversion Kits and Accessories for 705-DS and 7000/7010Dissolution ApparatusDescription Part Number1L Conversion KitsConversion kit, TruCenter, with ground groove, 1L 12-6100Conversion kit, TruCenter, with ground groove, 1L, with certificate 12-6100VConversion kit, TruCenter, with manual sampling evaporation cover, 1L 12-6101100 mL Conversion KitsConversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), for use with chuckassembly spindles, includes collet, 100 mL

12-0311

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

12-0316

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.

12-0317

Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.), for use with chuck assembly spindles, 100 mL

12-0318

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.

12-0319

Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.), flat bottom vessel, 100 mL

12-0301

Conversion kit, EaseAlign, with 19 in. paddle (3/8 in. dia. tapered to 1/4 in.),flat bottom vessel, 100 mL, 8/pkg.

12-0302

200 mL Conversion KitsConversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), includes collet,200 mL

12-0306

Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), includes collet,200 mL, 6/pkg.

12-0305

Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), includes collet,200 mL, 8/pkg.

12-0309

Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), flat bottom vessel,includes collet, 200 mL (one per position)

12-0313

Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), flat bottom vessel,includes collet, 200 mL, 6/pkg.

12-0304

2L Conversion KitsConversion kit, 6-vessel, 3x3, 2L, for 7000/7010 only 12-0400Conversion kit, 8-vessel, 4x4, 2L, for 7000/7010 only 12-0420Conversion Kits AccessoriesHeight spacer, for paddle and 100 and 200 mL round bottom vessels, 15 mm, for7000/7010 only

12-0320

Height spacer, for 100 and 200 mL, 3.25 in., for 7000/7010 only 12-0321Evaporation cover, EaseAlign, for use with 100/200 mL vessel 12-6315

32



Conversion Kits and Accessories for 7025 Dissolution ApparatusDescription Part Number100 mL Conversion KitConversion kit, TruCenter, with 15 in. paddle (3/8 in. dia. tapered to 1/4 in.),100 mL

12-0308

200 mL Conversion KitsConversion kit, TruCenter, with 14.5 in. paddle (3/8 in. dia. tapered to 1/4 in.),200 mL

12-0312

Conversion kit, TruCenter, with 14.5 in. paddle (3/8 in. dia. tapered to 1/4 in.),for use with AutoTemp, 200 mL

12-0314

Conversion Kits AccessoriesTruCenter vessel, with collar, 200 mL 12-5034TruCenter vessel, without collar, 200 mL 12-5033

Conversion Kits for 708-DS Dissolution ApparatusDescription Part NumberTruAlign vessel 100/200 mL conversion kit (includes vessel adapter andevaporation cover)

12-6368


12-1450


12-1451

708-DS conversion kit, 200 mL vessel with mini paddle

33



Capsule Wire, Weights and Sinker BasketsCapsule wire, weights and sinker baskets are used to retain a solid dosage form at the bottomof the vessel for testing when the dosage form is buoyant. Depending on your dosage form avariety of options are available.

• The flexible capsule wire has a 0.032 in. diameter and is made of made of stainless steel.The USP compendial wire is twisted around the dosage form in order to provide sufficientmass 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-oncaps use O-rings to seal the basket closed once the dosage form is inserted. The JapanesePharmacopoeia (JP) sinker basket is also available as an alternative.

• A three-prong capsule weight can be used to retain your capsule for testing. These weightsfit traditional capsule sizes one through three, and are sold individually.

When to Use a SinkerSinkers are used during a dissolutiontest to sink a dosage form that wouldotherwise float. The USP specifies thata small piece of non-reactive material,such as not more than a few turns of steel wire, can be attached to thedosage form to prevent floating. Othervalidated sinkers may also be used forthis purpose.

Did You Know?Weights and sinker baskets may alsobe used for sticky dosage forms, aswell as powders contained in capsuleshells.

Capsule weight wire (top row), two versions of wiresinkers and a Japanese sinker (second row), meshsinkers (third row) and 3-prong sinkers (fourth row)

Capsule Wire, Weights and Sinker BasketsDescription Part NumberCapsule Wire and WeightsCapsule weight wire, 316 stainless steel, 0.032 dia., 50 ft. 12-3000Capsule weight, 3-prong 12-3050Capsule weight, robotic type, with magnetic cap 12-3055Capsule weight, robotic type, with magnetic inserts in legs 12-3056Sinker BasketsSinker basket, with cover, 10-mesh, 1905 µm 12-3060Sinker basket, with cover, 8-mesh, 2591 µm 12-3062Sinker basket, with cover, 20-mesh, 864 µm 12-3063Sinker basket, with cover, 40-mesh, 381 µm 12-3064Sinker basket, with cover, 100-mesh, 140 µm 12-3065Sinker basket, with cover, 60-mesh, 229 µm 12-3066Sinker basket, with cover, 150-mesh, 104 µm 12-3067Sinker basket, with cover, 270-mesh, 53 µm 12-3068Sinker basket, with cover, 325-mesh, 45 µm 12-3072

Sinker Baskets DimensionsInside diameter 20.3 mm / 0.8 in. Outside diameter (with cover) 25 mm / 0.98 in.Inside height 11.7 mm / 0.46 in.Outside height (without cover) 15 mm / 0.59 in. Outside height (with cover) 20 mm / 0.79 in.

34



Manual sampling on the 708-DS

Sampling and Temperature MeasurementFor 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 pullsamples 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 iscritical that resident probe methods are validated against manual sampling to ensure theintegrity of the dissolution test is intact. Resident probes are available for the discontinued705-DS, as well as the 708-DS and non-Agilent apparatus.For automated sampling with Agilent’s discontinued (i.e., Varian or VanKel) 7000/7010Dissolution Apparatus, the automated manifold can be programmed to lower and raisesampling cannulas at specific timepoints when used with the 8000 Dissolution SamplingStation. The manifold supports sampling in media volumes between 750 mL and 1L. Thestandard 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 atlower volumes down to 500 mL, stainless steel cannula extensions may be added to thesampling cannula using a Teflon adapter. Full Flow Filters are recommended for sampling.The discontinued 7025 and 7030 Dissolution Apparatus include individual sampling cannulasthat may include temperature probes as well. The sampling depth of the cannulas is presetand 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 hydrodynamicdisturbance.The 708-DS and 709-DS also support an automated, non-resident manifold, which is includedin those systems preconfigured for automated sampling. Any unit without the automatedmanifold 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 theapparatus installed and volume. Contact your Agilent representative for details.Autosampling manifolds can also support the AutoTemp In-Vessel Temperature Sensing Systemto lower temperature probes at a specifically programmed time. Once the temperature ismeasured, the manifold removes the probes to avoid hydrodynamic disturbances. AutoTempmakes 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 andthe dosage forms are introduced. Like the Autosampling option, AutoTemp is available on newapparatus and may also be retrofitted to an existing instrument.

35



For Your Sampling NeedsAgilent offers a variety of heightspacers to increase working spacewhen performing manual sampling. See page 68 for Verification Tools,including these spacers.

Full Flow Filters are recommended foruse with automated sampling options.See page 39 for details.

(Left to right) Glass syringe, 4.75 in. bent cannula, 7.75 in. bent cannula with adjustable gauge kit andFull Flow Filters

Manual Sampling AccessoriesDescription Part NumberBent cannula with Luer Lock, for sampling from 900 mL in 1L vessels, 4.75 in. 12-3200Bent cannula with Luer Lock, for sampling from 500 mL in 1L vessels, 7.75 in. 12-3210Bent cannula, with adjustable gauge for setting height, 4.75 in. 12-3215Bent cannula, with adjustable gauge for setting height, 7.75 in. 12-3216Adjustable gauge kit, for 4.75 in. cannulas (cannulas not included) 12-3217Adjustable gauge kit, for 7.75 in. cannulas (cannulas not included) 12-3218Cannula, PEEK, for low-volume sampling 12-3219Filter holder, 25 mm 12-3220Glass syringe, 20 cc 12-3230Syringe, with 4.75 in. cannula assembly 12-3240Syringe, with 7.75 in. cannula assembly 12-3250Luer Lock fitting bracket, for manual sampling, for 7000/7010(requires sampling manifold)

17-3150

36



Sampling Cannulas and AccessoriesDescription Part NumberSampling cannula, 4.5 in. (for 7000/7010 manifold) 17-3300Sampling cannula, 6.5 in., for 500 mL in 1L vessel (for 7000/7010 manifold) 17-3305Cannula extension kit, 500 mL (for use with one 4.5 in. cannula) 17-3306Sampling cannula, 8.12 in., for 2L vessel (for 7000/7010 manifold) 17-3307Sampling cannula, 10 in., for 4L vessel (for 7000/7010 manifold) 17-3309Adapter, manual sampling cannula, for PNs 17-3311 and 17-3312 17-3310Manual sampling cannula assembly, 500 mL 17-3311Manual sampling cannula assembly, 900 mL 17-3312Sampling cannula, for 7025/7030 17-3313Return cannula, for 7025/7030 17-3314Manual sampling cannula, for sampling through apparatus head on 7025/7030 17-3317Return cannula, 2 1/4 in. 17-3320

Resident cannula kit on the 708-DS

Resident Sampling Kits/Accessories for the 7000/7010 DissolutionApparatusDescription Part NumberResident cannula and bushing, for sampling at 4.5 in. 12-0447Resident cannula kit, for stainless steel centering rings, 6/pkg. 12-0450Resident cannula kit, for EaseAlign centering rings, for use with paddles, 6/pkg. 12-0455Resident cannula kit, for EaseAlign centering rings, for use with baskets, 6/pkg. 12-0460Resident cannula kit, for EaseAlign centering rings, 1/pkg. 12-0465Resident cannula and bushing, for sampling at 2.5 in. 12-0467Evaporation cover, with UV-Vis adapter, for use with EaseAlign centering rings 12-0468

Resident Sampling Kits/Accessories for the 705-DS, 708-DS and TruCenterConversion KitsDescription Part Number708-DS resident sampling kit, 6-position, 900 mL K1001-01193708-DS resident sampling kit, 8-position, 900 mL K1001-01194708-DS resident sampling kit, 6-position, 500 mL K1001-01195708-DS resident sampling kit, 8-position, 500 mL K1001-01196Sample cannula assembly, 500 mL for 705/708-DS 17-3330Sample cannula assembly, 900 mL for 705/708-DS 17-3335

37



Manifolds for Automated Sampling and Temperature Measurement for the7000/7010 Dissolution ApparatusDescription Part NumberSampling Manifold with Internal Motor DriveSampling manifold, with motorized drive, for 3x3 configuration 17-3000Sampling manifold, with motorized drive, for 4x2 configuration 17-3005Sampling manifold, with motorized drive, for 4x4 configuration 17-3015Sampling manifold, for use with 200 mL and mini paddles, with motorized drive,for 3x3 configuration

17-3030

Internal Motor Drive (manifold not included)Internal motor drive, for 3x3 configuration 12-0200Internal motor drive, for 4x2, 4x3, 4x4 configurations 12-0205Sampling Manifold (internal motor drive not included)Sampling manifold, for use with 3x3 configuration, 1L 17-3100Sampling manifold, for use with 4x2 configuration, 1L 17-3102Sampling manifold, for use with 4x4 configuration, 1L 17-3107Sampling/temperature manifold, for use with 3x3 configuration, 200 mL 17-3111Sampling/temperature manifold, for use with 4x4 configuration, 200 mL 17-3112Sampling/temperature manifold, for use with 4x2 configuration, 200 mL 17-3113Sampling manifold, for use with 3x3 configuration, 200 mL 17-3115Sampling manifold, for use with 4x4 configuration, 200 mL 17-3116Sampling manifold, for use with 4x2 configuration, 200 mL 17-3117Sampling manifold, for use with UV Dissolution System and 4x3 or 4x4configurations

17-3120

Sampling/temperature manifold, for use with 4x3 or 4x4 configurations 17-3121Sampling manifold, for use with 4x4 configuration, 100 mL 17-3140Sampling manifold, for use with 4x2 configuration, 100 mL 17-3141Sampling/temperature manifold, for use with 4x4 configuration, 100 mL 17-3142Sampling/temperature manifold, for use with 4x2 configuration, 100 mL 17-3143AutoTemp Manifold with Internal Motor Drive (temperature probes only)AutoTemp manifold, with motorized drive, for 3x3 configuration 12-0601AutoTemp manifold, with motorized drive, for 4x2 configuration 12-0606AutoTemp manifold, with motorized drive, for 4x3 configuration 12-0611AutoTemp manifold, with motorized drive, for 4x4 configuration 12-0616AutoTemp Manifold (internal motor drive not included)AutoTemp manifold, for 3x3 configuration 12-0651AutoTemp manifold, for 4x2 configuration 12-0656AutoTemp manifold, for 4x3 configuration 12-0661AutoTemp manifold, for 4x4 configuration 12-0666Note: Motorized drives should be installed by your Agilent representative.

Non-resident sampling inside a 709-DS DVH vessel.

38



FiltrationDissolution continues until a sample is filtered, so it is critical to filter at the specifiedtimepoint. When using manual or automated sampling cannulas, you have the option to useone of Agilent’s Full Flow Filters or conventional filter tips to ensure the integrity of yourdissolution sample.

Full Flow FiltersMade of either ultrahigh molecular weight polyethylene (UHMWPE) or the polyvinylidenefluoride (PVDF), the Full Flow Filter offers increased surface area to optimize filter life andprevent 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 widevariety 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 1000.

Conventional Filter TipsStandard conventional filter tips are made of polyethylene fluoride and can also be used with1/8 in. diameter cannulas.

Automation FiltersAgilent also offers automation filters for use with the filter changer when finer filtration isrequired for multiple sample timepoints with a syringe pump.The 25 mm Whatman/Schleicher & Schuell MicroScience ROBY automation filters areindividually 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 avoidmembrane compression and ensure the integrity of the filter. Available in a wide variety ofmembranes, 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 Part NumberI Roby25 1 µm GF 92 filter, glass fiber The standard filter for difficult-to-filter samples

to retain course particles. 17-4150 = 1000/pkg.17-4151 = 200/pkg.

I Roby25 0.75 µm GF 55 filter, glass fiber The best filter for gelatinous capsule dosageforms.

17-4164 = 1000/pkg. 17-4165 = 200/pkg.

II Roby25 0.45 µm CA-GF filter, cellulose acetate glass fiber Extremely low protein binding, better than PVDF filters.

17-4160 = 1000/pkg. 17-4161 = 200/pkg.

II Roby25 0.45 µm NL filter, nylon Robust membrane allows for applications where protein binding is not critical.

17-4152 = 1000/pkg.17-4153 = 200/pkg.

III Roby25 0.45 µm NL filter, nylon glass fiber Most appropriate when membrane filters getclogged and a glass fiber filter alone is not asuitable substitute.

17-4154 = 1000/pkg.17-4155 = 200/pkg.

III Roby25 0.45 µm RC-GF filter, regenerated cellulose glass Most appropriate when membrane filters getclogged and a glass fiber filter alone is not asuitable substitute.

17-4158 = 1000/pkg.17-4159 = 200/pkg.

III Roby25 0.45 µm RC filter, regenerated cellulose Most appropriate when membrane filters getclogged and a glass fiber filter alone is not asuitable substitute.

17-4156 = 1000/pkg.17-4157 = 200/pkg.

Filter Classification: Category I = glass fiber filter, Category II = membrane filter, Category III = membrane plus glass fiber prefilter

The Agilent 808 Filter Changer works with the 25 mmROBY automation filters.

39



Full Flow Filters

Description Part NumberFilter validation sample kit 17-4195

Filter Validation KitDetermining the correct filter is simple with this kit, which contains seven different types offilters including 25 of each different membrane type. Filter selection validation guidance isalso included.

Order in BulkSave money by ordering oureconomical 1000 pack! Same highquality filters, just packaged in bulk.

Filters and Filter Tips for Sampling CannulasDescription Part NumberOriginal Full Flow FiltersFull Flow Filter, UHMWPE, blue, 10 µm, 100/pkg. 17-4000Full Flow Filter, UHMWPE, blue, 10 µm, 50/pkg. 17-4001Full Flow Filter, UHMWPE, blue, 10 µm, 1000/pkg. 17-4005Full Flow Filter, UHMWPE, white, 35 µm, 100/pkg. 17-4010Full Flow Filter, UHMWPE, white, 35 µm, 50/pkg. 17-4011Full Flow Filter, UHMWPE, white, 35 µm, 1000/pkg. 17-4015Full Flow Filter, UHMWPE, red, 70 µm, 100/pkg. 17-4020Full Flow Filter, UHMWPE, red, 70 µm, 50/pkg. 17-4021Full Flow Filter, UHMWPE, red, 70 µm, 1000/pkg. 17-4025Full Flow Filter, PVDF, green, 10 µm, 100/pkg. 17-4040Full Flow Filter, PVDF, green, 10 µm, 1000/pkg. 17-4045Full Flow Filter, PVDF, yellow, 35 µm, 100/pkg. 17-4050Full Flow Filter, PVDF, yellow, 35 µm, 1000/pkg. 17-4055Filter TipsFilter tip, PE, 2 µm, 100/pkg. 17-4100Filter tip, PE, 5 µm, 100/pkg. 17-4110Filter tip, PE, 10 µm, 100/pkg. 17-4120Filter tip, PE, 20 µm, 100/pkg. 17-4130Filter tip, PE, 45 µm, 100/pkg. 17-4140Note: PE = polyethylene, PVDF = polyvinylidene fluoride, UHMWPE = ultrahigh molecular weight polyethylene

40



EaseAlign centering ring and Evaporation Covers

Centering Rings and Evaporation CoversSome legacy Varian and VanKel dissolution apparatus use centering rings to ensure vesselsare perfectly centered every time and to ensure empty vessels do not float when the waterbath is filled. Depending on your apparatus, TruAlign, TruCenter or EaseAlign centering ringsand vessels can be used.Evaporation covers maintain volumetric accuracy of the media used during dissolution testingby slowing the amount of media lost to evaporation. Like the centering rings, a variety ofevaporation covers are available to fit your apparatus and vessels. Evaporation plugs are usedto minimize evaporation by sealing unused ports in the evaporation covers.

Centering Rings and AccessoriesDescription Part NumberCentering ring, EaseAlign, for 705-DS and 7000/7010 12-6050Centering ring, EaseAlign, retrofit, 6-position, includes pins and evaporationcovers

12-6060

Centering ring, EaseAlign, retrofit, 8-position, includes pins and evaporationcovers

12-6062

Locating pins, EaseAlign, 12/pkg. 12-6065Conversion kit, EaseAlign, for Hanson vessels, 6/pkg. 12-6070Alignment plate, TruCenter 12-6115

41



Evaporation Covers and AccessoriesDescription Part NumberEvaporation cover, low-loss split hinge design 12-6327Evaporation cover, low-loss hinged, for EaseAlign centering rings 12-6328Evaporation cover, low-loss hinged, for use with resident probes 12-6329Evaporation cover, amber, with DDM opening, for EaseAlign centering rings 12-6311Evaporation cover, for use with 4L vessels 12-6326Evaporation cover, standard, for stainless steel centering rings 12-6200Evaporation cover, robotic Zymark type, for stainless steel centering rings 12-6205Evaporation cover, EaseAlign 12-6300Evaporation cover, EaseAlign, PVC 12-6301Evaporation cover, EaseAlign, for basket 12-6305Evaporation cover, for basket and stainless steel centering rings 12-6306Evaporation cover, EaseAlign, for DDM 12-6310Evaporation cover, EaseAlign, for use with 100/200 mL vessel 12-6315Evaporation cover, EaseAlign, amber 12-6320Evaporation cover, for stainless steel rings, 4L 12-6325Evaporation cover, for use with EaseAlign, solid cover for non-vessel positions 12-6330Evaporation cover, manual sampling, opening for Japanese sinkers, for 7025/7030

12-6352

Evaporation cover, dual sampling, for 7025/7030 12-6353Evaporation cover, manual sampling for baskets, opening for Japanese sinkers,for 7025/7030

12-6362

Evaporation cover, manual sampling for baskets, with DDM, for 7025/7030 12-6363Evaporation cover, for three openings for basket and two sampling ports 12-0463Evaporation cover, for single opening for basket and auto start 12-0464Evaporation plugs, 36/pkg. 12-6350Evaporation hole plug, for 7025/7030 12-6358708-DS/709-DS evaporation cover, low-loss seal 1005-1812708-DS/709-DS evaporation cover, standard seal 1005-1813708-DS/709-DS evaporation cover, low-loss seal, amber 1005-1899708-DS/709-DS evaporation cover, standard seal, amber 1005-1900708-DS/709-DS evaporation cover retainer post, for use in place of DDM 1005-1898708-DS/709-DS evaporation cover plug, white, for use in place of DDM 1200-1012708-DS/709-DS evaporation cover plug, black, fingertip, for alternative sample opening

12-6365

708-DS/709-DS evaporation cover plug, black, fingertip, for alternative sample opening, 6/pkg.

12-6370

Amber and clear evaporation covers for the 708-DS and 709-DS.

42



Teflon Suspension Cup

Transdermal Delivery Systems – USP Apparatus 5, 6, and 7

USP Apparatus 5 – Paddle Over DiskThe Paddle Over Disk assembly is used for the dissolution testing of transdermal patches, andis used with a standard dissolution apparatus and paddles. The assembly is made of a 316stainless steel disk and Teflon locking ring that holds the removable, replaceable screens inplace. Screens are provided with the ring assemblies but are also offered in a variety of othersizes which are sold separately.Agilent also offers a transdermal patch holder system as an alternative to the traditionalApparatus 5 assembly. Also made of 316 stainless steel, the O-ring assembly eliminates theneed for adhesives to hold the patch. The clam-shell design secures the patch in place andexposes only the active release area of patches with an inactive perimeter around the releasearea. Custom holders are also available by simply contacting your Agilent representative.

USP Apparatus 6 – Rotating CylinderThe Rotating Cylinder assembly uses a 316 stainless steel cylinder and includes four slots atthe top for improved media circulation over the transdermal patch. The two-piece designincludes a removable extension for testing larger transdermal patches.

USP Apparatus 7 – Reciprocating HolderTransdermal delivery systems may also be tested with Apparatus 7 using a variety of sampleholders. For more information on the instrumentation and holders available from Agilent, see page 56.

Teflon Suspension CupsFor suspensions, the Teflon suspension cup is a weighted holder with a hemispheric bottomdesigned to sit at the bottom of a standard 1L vessel to control the exposed surface area. Thesuspension is weighed in the center cup prior to analysis in order to correlate the release rate.

Apparatus 5, or Paddle Over Disk, and Apparatus 6, Rotating Cylinder, are commonly used forthe testing of transdermal patches per USP General Chapter <724>.

Agilent's 708-DS can also supporttransdermal testing using USPApparatus 5 and 6 accessories. Thisincludes setup and storage of precisesampling manifold locations in thefirmware based on vessel volume andthe assembly installed. The 708-DS iseasily converted to smaller volumestypically associated with transdermaltesting as well. See page 18 for moreinformation about 708-DS volumeconversion kits.

Did You Know?

43



(Left to right) Paddle Over Disk assemblies, transdermalpatch holders and suspension cup.

Transdermal Delivery SystemsDescription Part NumberPaddle Over DiskPaddle Over Disk assembly, with 35 mm opening, 40-mesh screen 12-4200Paddle Over Disk assembly, with 35 mm opening, 40-mesh screen, with certificate

12-4200V

Paddle Over Disk assembly, 125 µm, EP 12-4201Replacement screens, 125 µm, EP, 100/pkg. 12-4209Replacement screens, 35 mm openings, 40-mesh, 100/pkg. 12-4210Disk disassembly kit, for PN 12-4200 12-4211Paddle Over Disk assembly, with 56 mm opening, 120-mesh screen 12-4230Replacement screens, 56 mm openings, 120-mesh, 100/pkg. 12-4231Disk disassembly kit, for PN 12-4230 12-4232Transdermal Patch HoldersTransdermal patch holder, 2.5 cm2 12-4300

Transdermal patch holder, 5.0 cm2 12-4310

Transdermal patch holder, 7.0 cm2 12-4320

Transdermal patch holder, 10.0 cm2 12-4330Watch glass screen, polypropylene, 6/pkg. 12-4400Watch glass screen, stainless steel, 6/pkg. 12-4410Suspension CupsWeighted holder, 5.72 cm outside dia., 0.52 cm inside dia. 12-4050Insert cup, 17.5x8.2 mm, use with PN 12-4050 12-4055Insert cup, 20x8.2 mm, use with PN 12-4050 12-4060

Rotating Cylinder and AccessoriesDescription Part NumberRotating Cylinder, 4.45 cm outside dia. 12-1360Rotating Cylinder, 4.45 cm outside dia., with certificate 12-1360VRotating Cylinder, 25 mm outside dia. 12-1365Rotating Cylinder, 4.45 cm outside dia., for 7025 only 12-1380Rotating Cylinder, 25 mm outside dia., for 7025 only 12-1385Lower interchangeable shaft for Rotating Cylinder 12-1371Lower interchangeable shaft for Rotating Cylinder, with certificate 12-1371VRotating Cylinder, 25 mm outside dia., with interchangeable shaft 12-1372Cuprophan membrane, 126x345 mm, 10 sheets/pkg. 12-1370Height gauge, Rotating Cylinder, USP 12-7335

44



Enhancer Cell and accessories

Enhancer CellDesigned for release rate dissolution testing of ointments, creams, gelsand topicals

Used in research, quality control and product development laboratories, the Enhancer Cellprovides release rate data for topicals using your standard Apparatus 1 or 2 with either astandard 1L paddle method or 200 mL vessel with mini paddle. Also known as the VerticalDiffusion Cell and External Receptor Chamber Type, the Enhancer Cell is a Teflon cell withadjustable volume and retaining cap to eliminate air pockets trapped against the skin orartificial membrane that provide the diffusion barrier. It is a cost-effective alternative toinvesting 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 cm2

• 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 adjustmenttool. 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 cm2 surface area size.

The Enhancer Cell conforms to the proposed USP Pharmacopeial Forum Chapter <1724>Performance Tests for Topical Drug Products.

Did You Know?The Enhancer Cell is now included inthe new USP General Chapter <1724>Semisolid Drug Products - PerformanceTests to appear in USP35 - NF20, 2ndsupplement, 2012.

45



Enhancer Cell Ordering ExamplesIn addition to your apparatus, the following ordering examples describe the items that shouldbe ordered for Enhancer Cell use.

Enhancer Cell Ordering Example 1: 708-DS conversion, 6 positions, 4 cm2 Enhancer CellQuantity Description Part Number6 Enhancer Cell, 4 cm2 surface area membrane (one per position) 12-40001 Alignment tool, for 4 cm2 Enhancer Cell (only one required) 12-40101 Adjustment tool, for all Enhancer Cell sizes (only one required) 12-40156 Mini paddle, lower interchangeable, electropolished stainless steel

(one per position)12-1443

6 TruAlign vessel, flat bottom, 200 mL (one per position) 12-51706 TruAlign vessel 100/200 mL conversion kit, includes vessel adapter

and evaporation cover, (one per position) 12-6368

Enhancer Cell Ordering Example 2: 7010, 8 positions, 0.5 cm2 EnhancerCell, with 15 in. shafts and a sampling/temperature manifoldQuantity Description Part Number8 Enhancer Cell, 0.5 cm2 surface area membrane (one per position) 12-40021 Alignment tool, for 0.5 cm2 Enhancer Cell (only one required) 12-40121 Adjustment tool, for all Enhancer Cell sizes (only one required) 12-40158 Conversion kit, EaseAlign, with 15 in. paddle (1/4 in. dia.), flat

bottom vessel, includes collet, 200 mL (one per position)12-0313

1 Sampling/temperature manifold, for use with 4x4 configuration, 200 mL

17-3112

Enhancer Cells and AccessoriesDescription Part NumberEnhancer Cell, 4 cm2 surface area membrane (one per position) 12-4000

Enhancer Cell, 2 cm2 surface area membrane (one per position) 12-4001

Enhancer Cell, 0.5 cm2 surface area membrane (one per position) 12-4002

Enhancer Cell kit, 4 cm2 surface area membrane, adjustment and alignmenttools

12-4005

Alignment tool, for 4 cm2 Enhancer Cell (only one required) 12-4010

Alignment tool, for 2 cm2 Enhancer Cell (only one required) 12-4011

Alignment tool, for 0.5 cm2 Enhancer Cell (only one required) 12-4012Adjustment tool, for all Enhancer Cell sizes (only one required) 12-4015Cuprophan membrane, 126x345 mm, 10 sheets/pkg. 12-1370

46



Intrinsic Dissolution Apparatus and accessories

Intrinsic Dissolution ApparatusThe Intrinsic Dissolution Apparatus provides the dissolution rate of a pure activepharmaceutical ingredient (API) by exposing the API to a constant surface area of dissolutionmedium. The intrinsic rate is determined by rotating the apparatus in a dissolution vesselcontaining 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 theexposed surface area with respect to time.Based on the modified Woods Apparatus as described in USP <1087>, the design includesthreaded rings on the inside of the die cavity to prevent the compacted API from falling out ofthe die cavity during analysis. The apparatus includes a punch used to compress the API into apellet with the aid of a laboratory press (not provided by Agilent). The Intrinsic Apparatus includes:

• Stainless steel die cavity with 0.5 or 0.125 cm2 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/cm2, and is useful in studying the solubility characteristics of a pure drug substance.

47



Intrinsic Dissolution Ordering Example 1: 708-DS, 6 positionsQuantity Description Part Number6 Intrinsic Dissolution Apparatus, 0.5 cm2 exposed surface area,

with punch, shaft and holder, for 7000E, 708-DS, 705-DS12-4101

1 Surface plate, for Intrinsic Dissolution 12-4130

Intrinsic Dissolution Ordering Example 2: 7010, 8 positions, with 15 in. shafts Quantity Description Part Number8 Intrinsic Dissolution Apparatus, 0.5 cm2 exposed surface area,

with punch, shaft and holder, for 7000/701012-4100

1 Surface plate, for Intrinsic Dissolution 12-4130

Intrinsic Dissolution ApparatusDescription Part NumberIntrinsic Dissolution Apparatus, 0.5 cm2 exposed surface area, with punch, shaft and holder, for 7000/7010*

12-4100

Intrinsic Dissolution Apparatus, 0.5 cm2 exposed surface area, with punch, shaft and holder, for 7000E/7010, 708-DS, 705-DS*

12-4101

Intrinsic Dissolution Apparatus, 0.5 cm2 exposed surface area, for use with 7025* 12-4105

Intrinsic Dissolution Apparatus, 0.125 cm2 exposed surface area* 12-4110

Intrinsic Dissolution Apparatus, 0.125 cm2 exposed surface area, for 7025* 12-4111

Intrinsic die, 0.5 cm2 exposed surface area 12-4120Punch 12-4140Shaft and die holder only, for intrinsic dissolution 12-4150Surface plate, for intrinsic dissolution 12-4130*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 ExamplesIn addition to the standard dissolution apparatus, to configure the base unit for intrinsicdissolution use, see the following examples:

48



750 Heater/Circulator

Water Baths and Heater/CirculatorsAgilent offers a number of water baths and replacement parts for the water baths, includingfittings, adapters, tubing and clamps, as well as heater/circulators.

• Acrylic fabricated water baths for disintegration testers, the Rotating Bottle and BIO-DISapparatus are made of a three-piece construction with solvent-welded seams.

• The molded high-performance polymer PETG design, utilized on most Agilent dissolutionapparatus, provides better chemical and heat stability than standard acrylic baths and therounded corners make cleaning easier.

• The 750 External Heater/Circulator is a bench-top, all purpose heater/circulator thatmonitors water bath temperature directly using an internal thermistor. Additionalreplacement heater/circulators for use with current or previous models as well as OEMdissolution apparatus are offered in both 115 and 230 voltages. The 750 ExternalHeater/Circulator is compatible with 7000/7010, BIO-DIS, Apparatus 7 and can also beused with non-Varian dissolution apparatus.

• The 7025 and 705-DS dissolution apparatus require different heater/circulators speciallydesigned for each model series. Please refer to the chart to select the appropriateheater/circulator, as well as the correct voltage.

• The 708-DS utilizes a universal voltage heater/circulator. It is designed specifically to fitbeneath the apparatus housing and minimize vibration.

49



Molded Water Bath

Acrylic Water Bath

Water Baths, Heaters/Circulators and AccessoriesDescription Part NumberWater Baths and Replacement PartsWater bath, molded, conversion kit for 3x3 configuration 60-1000Water bath, molded, conversion kit for 4x4 configuration 60-1100Water bath, molded, conversion kit for 12-spindle 19 in. paddles/baskets 60-1200Water bath, molded, conversion kit for 16-spindle 24 in. paddles/baskets 60-1300Water bath, molded, for use with 3x3 configuration 60-1400Water bath, molded, for use with 4x4 configuration 60-1500Water bath, 19x12x8 in. 60-2000Water bath, 12x12x8 in. 60-2020Water bath, 24x12x8 in. 60-2100Water bath, for 7025 and 7030 60-2110Water bath, for 100 Automated Disintegration Tester, with fittings 60-2120Water bath, for Rotating Bottle, 24x12x12 in. 60-2200Water bath, 38x12x8 in. 60-2250Water bath, 42x12x8 in. 60-2300Water bath, for BIO-DIS, 22.56x20.68x7.5 in. 60-2400Water bath, for 2 and 4L or Rotating Bottle, 19x12.7x15.3 in. 60-2500Water bath, for 2L, 8-spindle, 24.5x12.7x15.3 in 60-2600Drain valve for molded bath 62-9000Bulkhead bath fitting 62-9010Bath flow deflector 62-9020Barbed angle adapter 62-9025PVC tubing with 3/4 in. outer dia., 1/2 in. inner dia., 50 ft. 62-9030Bath tubing clamps, stainless steel, 4/pkg. 62-9040Heater/Circulators750D heater/circulator, 115V 65-3000750D heater/circulator, 230V 65-3100Heater/circulator, for 7025, 115V 65-3800Heater/circulator, for 7025, 230V 65-3810Heater/circulator, universal, 115V 65-3820Heater/circulator, universal, 230V 65-3830Heater/circulator, with Wide Input Range Heater, for 708-DS, 115/230V 65-3850

Did You Know?Several vessel plate configurationswere available with the 7000/7010Dissolution Apparatus. To helpdistinguish:3x3 – indicates 2 rows of 3 vessels4x2 – indicates 2 rows of 4 vessels

with 6 active spindle locations(back 2 middle positions empty)

4x4 – indicates 2 rows of 4 vesselswith 8 active spindle locations

50



BIO-DIS Reciprocating Cylinder Apparatus

Apparatus 3

BIO-DIS Reciprocating Cylinder Apparatus andAccessoriesExtended release-rate dissolution testing that meets requirements of USPApparatus 3 and EP Reciprocating Cylinder specificationsThe Agilent BIO-DIS Reciprocating Cylinder Apparatus is ideal for automatic dissolution testingof dosage forms that require different types of media. Typically used for imitating the pHchanges that occur in the body, this instrument is perfectly suited for extended and sustainedrelease dosage forms. The BIO-DIS can automatically perform a complete media change, simulating the shift fromstomach 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 forextended periods of time, the BIO-DIS can store up to 15 programs and provide direct controlover 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 instrumentautomatically traverses up to six rows of corresponding outer media tubes filled with differentmedia. Custom instruments with additional rows are available as well.

Features include:

• Simulate gastrointestinal conditions with simple programming that allows in vitro dissolutionpH 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 operatorintervention.

• 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 volumeconfiguration to meet testing needs for low dose or poorly soluble formulations. Otheroptions 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:

Did You Know?The BIO-DIS Reciprocating CylinderApparatus requires a periodicPerformance Qualification (PQ) usingchlorphenirame maleate extended-release tablets, according to the USPPVT for Apparatus 3. To arrange thisservice, contact your Agilentrepresentative:www.agilent.com/chem/contactus

• 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

51



Automated Sampling for BIO-DISEasily automate the sample collectionprocess for Apparatus 3 using theAgilent 8000 Dissolution SamplingStation. See page 73 for more details.

Filtration OptionsAccomplish manual inline filtrationusing 5 µm disc filters with Luer Lockfittings. See page 38 for more details.Or use the 808 Filter Changer and 806Syringe Pump to automate filtrationwith 25 mm automation-ready filtersthat sample down to 0.45 µm pore size.See page 78 for more details.

BIO-DIS accessories

BIO-DIS Reciprocating Cylinder ApparatusDescription Part NumberBIO-DIS, 115V, 60 Hz 25-1000BIO-DIS, 230V, 50 Hz 25-1100Conversion and Retrofit KitsConversion kit, 100 mL 27-6100Conversion kit, 1L 27-6105Conversion kit, double row dip, 300 mL 27-6200Conversion kit, double row dip, 1L 27-6202Conversion kit, double row dip, 1L / 300 mL 27-6204Retrofit kit, double row dip, 300 mL* 27-6201Retrofit kit, double row dip, 1L* 27-6203Retrofit kit, double row dip, 1L / 300 mL* 27-6205*Retrofit kits must be installed by an Agilent representative

Did You Know?The Dissolution Workstation Softwarecan be used to control up to four (4)systems with the BIO-DIS, a pump, andthe 8000 Dissolution Sampling Station.In fact, the software allows for multiplesamples per row and additional mediachanges beyond the traditionalcapability of the instrument.

52



BIO-DIS Reciprocating Cylinder AccessoriesDescription Part NumberInner Sample Tubes (with threaded glass ends)Standard inner sample glass tube for 300 mL outer media tube 27-5000Inner sample glass tube for 100 mL outer media tube 27-5010Outer Media TubesOuter media tube, USP, 300 mL 27-5100Outer media tube, 100 mL 27-5110Outer media tube, 100 mL, with 100 mL calibration line 27-5111Outer media tube, 100 mL, with 50 mL calibration line 27-5112Outer media tube, flat bottom, 1000 mL 27-5120Outer media tube, 300 mL, graduated 27-5170Upper and Lower CapsStandard upper cap, USP, 300 mL, for use with P/N 27-5000 27-1000Upper cap, 100 mL, for use with P/N 27-5010 27-1010Standard lower cap, USP, 300 mL, for use with P/N 27-5000 27-1020Lower cap, 100 mL, for use with P/N 27-5010 27-1030Lower cap, wider diameter for improved mixing, for use with P/N 27-5000 27-1050Sample and Return CannulasSample and return cannula, 5.5 in. 27-6500Return cannula, 2.75 in. 27-6520Evaporation CapsEvaporation cap, USP, for 300 mL tube 27-1500Evaporation cap, for 100 mL tube 27-1510Evaporation cap, USP, tinted, for 300 mL tube 27-1520Vessel Carrier for Outer Media TubesVessel carrier, for 300 mL tube, 7x2 layout, set of 3 27-6000Vessel carrier, for 100 mL tube, 7x2 layout, set of 3 27-6005Vessel carrier, for 1000 mL tube, 1x3 layout, set of 3 27-6010

(Continued)

Did You Know?Apparatus 3 may also be used fordisintegrating dosage forms by using27-1050 which creates improvedmixing for particulates that may passthrough the lower screen.

53



BIO-DIS DimensionsHeight Width Depth Weight73.66 cm / 29 in. 68.58 cm / 27 in. 69.85 cm/ 27.5 in. 43.1 kg / 95 lbs,

dry without vessels

Replacement Screens for Inner Sample TubesPolypropylene screens, 1.25 in. dia. for 300 mL tubes, 20-mesh, 840 µm 27-2000Polypropylene screens, 1.25 in. dia. for 300 mL tubes, 40-mesh, 405 µm 27-2005Polypropylene screens, 1.25 in. dia. for 300 mL tubes, 56-mesh, 250 µm 27-2007Polypropylene screens, 1.25 in. dia. for 300 mL tubes, 78-mesh, 177 µm 27-2010Polypropylene screens, 1.25 in. dia. for 300 mL tubes, 100-mesh, 150 µm 27-2015Polypropylene screens, 0.75 in. dia. for 100 mL tubes, 20-mesh, 840 µm 27-2200Polypropylene screens, 0.75 in. dia. for 100 mL tubes, 40-mesh, 405 µm 27-2205Polypropylene screens, 0.75 in. dia. for 100 mL tubes, 78-mesh, 177 µm 27-2210Polypropylene screens, 0.75 in. dia. for 100 mL tubes, 100-mesh, 150 µm 27-2215Stainless steel screens, 1.25 in. dia. for 300 mL tubes, 10-mesh, 1905 µm 27-2099Stainless steel screens, 1.25 in. dia. for 300 mL tubes, 20-mesh, 864 µm 27-2100Stainless steel screens, 1.25 in. dia. for 300 mL tubes, 30-mesh, 533 µm 27-2103Stainless steel screens, 1.25 in. dia. for 300 mL tubes, 40-mesh, 381 µm 27-2105Stainless steel screens, 1.25 in. dia. for 300 mL tubes, 100-mesh, 140 µm 27-2110Stainless steel screens, 1.25 in. dia. for 300 mL tubes, 200-mesh, 74 µm 27-2115Stainless steel screens, 1.25 in. dia. for 300 mL tubes, 300-mesh, 46 µm 27-2120Stainless steel screens, 1.25 in. dia. for 300 mL tubes, 400-mesh, 38 µm 27-2125Stainless steel screens, 0.75 in. dia. for 100 mL tubes, 8-mesh, 2591 µm 27-2300Stainless steel screens, 0.75 in. dia. for 100 mL tubes, 10-mesh, 1905 µm 27-2305Stainless steel screens, 0.75 in. dia. for 100 mL tubes, 20-mesh, 864 µm 27-2310Stainless steel screens, 0.75 in. dia. for 100 mL tubes, 40-mesh, 381 µm 27-2315

BIO-DIS Reciprocating Cylinder AccessoriesDescription Part Number

Stainless steel screens, 0.75 in. dia. for 100 mL tubes, 60-mesh, 229 µm 27-2320Basket AdaptersBasket adapter, Durafit 27-2400Basket adapter with clip assembly 27-2401

BIO-DIS screens

54



Reciprocating Holder Apparatus 7 andAccessoriesThe Agilent Reciprocating Holder Apparatus 7 is ideal for automatic dissolution testing of dosageforms that require a change of media, a smaller volume or more vigorous agitation. Initially developedfor 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 dipbetween 5 and 40 dips per minute. At the end of a designated time period, the dosage form isautomatically transported from one row to the next. Typical products tested include extendedrelease tablets, capsules, transdermals, osmotic pumps and arterial stents.The standard apparatus has seven reciprocating positions in each of the six rows and is availablewith 100 or 300 mL outer tubes. The firmware can be preprogrammed to automatically move toa fresh row of media for as many as six media changes. For an increased number of mediachanges or smaller volumes, the instrument is also available in a standard 12-position, 12-rowconfiguration 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 anApparatus 7 with an 8000 Sampling Station. By incorporating PC control, additional mediachanges can be accommodated by exchanging the vessel racks with fresh media.

• Simulates the biorelevant conditions for the skin, gastrointestinal tract and tissue required fortransdermal, oral drugs and implants with biorelevant temperature agitation rates andretention times.

• Tests and transports a variety of samples, saving valuable bench space. Samples areautomatically transported from one medium to the next without operator intervention, andcan 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 kitsare 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

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• PrinterNote: Sample/dosage form holders must be ordered separately.

Dosage Holder OptionsAgilent offers a variety of standard andcustomizable holder options to meetyour application needs. These includereciprocating disks, angled disks, andcylinders for transdermal patches. For traditional oral dosage forms,acrylic pointed rods, stent holders and mini baskets are available.

Integration Options forSampling and FiltrationBoth the seven- and twelve-rowsystems can be integrated with the8000 Dissolution Sampling Station, 808 Filter Changer and 806 SyringePump to automate filtration with 25 mm automation-ready filters thatsample down to 0.45 µm pore size.Inline filtration is also possible using 2-way Luer Lock filters.

The Reciprocating Holder Apparatus 7:

Apparatus 7

Reciprocating Holder Apparatus 7

Note: Select accessory kit to specify 100 or 300 mL outer tubes.

55



Reciprocating Holder Apparatus 7 Description Part NumberApparatus 7, 7-row, 100/300 mL, 115V 25-2000Apparatus 7, 7-row, 100/300 mL, 230V 25-2100Apparatus 7, Alza, 12-row, 115V 25-2490Apparatus 7, Alza, 12-row, 230V 25-2495Apparatus 7, 12-row, 100/300 mL, 115V 25-2500Apparatus 7, 12-row, 100/300 mL, 230V 25-2600

Reciprocating Holder Apparatus 7 AccessoriesDescription Part NumberPointed acrylic rod 27-3000Transdermal patch holder kit 27-3001Replacement acrylic rod kit 27-30021.6 cm2 reciprocating disk 27-8005

2.5 cm2 reciprocating disk 27-8010



10.0 cm2 reciprocating disk 27-8025Angled disk, 1.98 in. 27-8035Angled disk, 1.42 in. 27-8036Basket shaft, mini 27-8600Basket, mini, 40-mesh 27-8620Basket, mini, 50-mesh 27-8621Basket assembly, titanium 27-8622Spring holder, 1.45 in. L x 0.58 in. inner dia. x 0.031 in. wire inner dia. 27-0100Spring holder, 1.40 in L x 0.31 in inner dia. x 0.040 in. wire inner dia. 27-0101Spring holder, 0.96 in L x 0.33 in inner dia. x 0.031 in. wire inner dia. 27-0102Spring holder, 0.60 in L x 0.25 in inner dia. x 0.040 in. wire inner dia. 27-0103Spring holder, 1 in. L x 0.50 in. inner dia. x 0.031 in. wire inner dia. 27-0104Spring holder, 1.45 in. L x 0.58 in. ID x 0.031 in. wire inner dia. 27-0105Spring holder, 1.40 in. L x 0.31 in. ID x 0.040 in. wire inner dia. 27-0106Spring holder, 0.96 in. L x 0.33 in. ID x 0.031 in. wire inner dia. 27-0107Spring holder, 0.60 in. L x 0.25 in. ID x 0.031 in. wire inner dia. 27-0108Spring holder, 1.00 in. L x 0.50 in. ID x 0.031 in. wire inner dia. 27-0109Outer tube, 50 mL 27-5130Outer tube, calibrated, 50 mL, class B 27-5135Outer tube, 50 mL, amber 27-5160

Did You Know?The compatibility table on page 56provides details on holders and outertube volumes for your specific testingneeds.

Reciprocating Holder Apparatus 7 Accessory KitsDescription Part NumberChoose one (1) of the following kits to accompany a 7-row Apparatus 7:Apparatus 7, 100 mL Accessory Kit 1002-0383Apparatus 7, 300 mL Accessory Kit 1002-0384

56



Reciprocating Holders

BIO-DIS Reciprocating Cylinder and Reciprocating Holder Apparatus 7Compatibility Table

Part Number Holder

Apparatus 3 – Outer Tube50 mL 100 mL 300 mL

(USP)1000 mL

27-5000 Inner tube (300 mL) - - ] ]

27-5010 Inner tube (100 mL) - ] ] ]

12-2100 Basket, USP, 40-mesh, 381 µm - - ] ]

27-2400 Durafit basket adapter - NR ] ]

27-2401 Basket adapter with clip assembly - NR ] ]

Apparatus 7 – Outer Tube50 mL 100 mL 300 mL

(USP)1000 mL

27-5000 Inner tube (300 mL) - - ] ]

27-5010 Inner tube (100 mL) - ] ] ]

27-2400 Durafit basket adapter - NR ] ]

27-2401 Basket adapter with clip assembly - NR ] ]

27-8620 Basket, mini, 40-mesh ] NR ] ]

27-8621 Basket, mini, 50-mesh ] ] ] ]

27-8600 Basket shaft, mini ] ] ] ]

27-8622 Basket assembly, titanium ] ] ] ]

27-3000 Pointed acrylic rod ] ] ] ]

27-3002 Replacement acrylic rod kit ] ] ] ]

27-3001 Transdermal patch holder kit - - ] ]

27-8005 1.6 cm2 reciprocating disk ] ] ] ]

27-8010 2.5 cm2 reciprocating disk - - ] ]



27-8025 10.0 cm2 reciprocating disk NR NR ] ]

27-6540 Replacement stent holder ] ] ] ]

27-6541 Stent holder, 8 mm (horizontal) ] ] ] ]

27-6542 Stent holder, 18 mm (vertical) ] ] ] ]

27-6543 Stent holder, 30 mm (vertical) ] ] ] ]

27-0101 Spring holder, 1.40 in. L x 0.31 in. inner dia. x 0.040 in. wire inner dia.

]* ]* ]* ]


]* ]* ]* ]


]* ]* ]* ]

27-0104 Spring holder, 1 in. L x 0.50 in. inner dia. x 0.031 in. wire inner dia.

] ] ] ]

27-8035 Angled disk, 1.98 in. - - - ]

27-8036 Angled disk, 1.42 in. - - - ]

Diamond image (]) = Compatible, Shaded box = Not compatible, NR = Not Recommended, Asterisk (*) = based on dimension measurements only

57

The 400-DS sets the performance standard for small-volume drug-release testing of medicaldevices such as drug eluting stents (DES) that release small amounts of active pharmaceuticalingredients (API) during a long period of time. Also used for testing extractables andleachables, and extended-release pharmaceutical products, the apparatus offers bathlessheating, custom medical device holders, integrated autosampling, media replacement andliquid handling capabilities.Systems are available in sample cell sizes of 5 or 10 mL. Dissolution can be performed involumes as low as 3 mL, providing significant gains in sample concentration for UV or LCanalysis 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 11environment. 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:

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



400-DS Apparatus 7The first compendial small-volume dissolution testingapparatus for novel dosage forms


• Saves time by simultaneously testing up to 13 samples, or 12 samples and a control orstandard, while providing users direct visibility of each dissolution cell

• Maintains temperature control through internal temperature probes and external heatingjackets; no water bath is required

• Minimizes evaporation through the fully closed system and the integrated syringe pump andautosampler 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

58



400-DS cell holder with stent

Internal view of cell holders

Dissolution Cell Design

400-DS Dissolution – Apparatus 7Description Part Number400-DS, with PC, printer, software, 5 mL cell 33-0105400-DS, 5 mL cell 33-0106400-DS, with PC, printer, software, 10 mL cell 33-0505400-DS, 10 mL cell 33-0506

400-DS AccessoriesDescription Part NumberDissolution Workstation Software for 400-DS 11-0035Dissolution cell, 10 mL 33-9000Dissolution cell, 5 mL 33-9005Dissolution cell, 5 mL, amber 33-9043Dissolution cell, 10 mL, amber 33-9044Heater element with cable assembly, 10 mL 33-9001Heater element with cable assembly, 5 mL 33-9006Vial tray row, single, 1.5 mL 33-9013Vial tray row, single, 4 mL 33-9002Extraction tool 33-9007Vial, pre-crimped 12x32, 100/pkg. 33-9010Glass vial, clear, with PTFE/silicon cap, 15x45, 100/pkg. 17-5030Accessory kit, 10 mL 33-9030Accessory kit, 5 mL 33-9040

• A glass tube, open at both ends, is placed on top of the fluidics module, and a heatingjacket surrounds each tube (no water bath is required). The bottom end is capped by thesampling 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 temperatureprobe at the bottom of each cell.

• The 400-DS supports the USP-specified stroke length of 20 ± 1 mm required for Apparatus 7.

(Continued)

59



400-DS sample holders

400-DS DimensionsHeight Width Depth Weight58.42 cm / 23 in. 53.34 cm / 21 in. 59.69 cm / 23.5 in. 58.97 kg / 130 lb.

400-DS SpecificationsReciprocation length 20.0 ± 1.0 mmDip Rate 1-35 ± 0.5% DPMTemperature Ambient + 5 to 50 ± 0.2°CVolume (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 daysNumber of Timepoints Up to 36 (with tray change)Number of Samples (per test) 1 to 13Input Voltage 115V / 230V AC; 50 / 60 HzTypes of Media (per test) Up to 4 plus rinseEvaporation 0.2% or better over 24 hours

400-DS sample tray

400-DS Sample HoldersStent holder assembly, 10 mL 33-9012Stent holder assembly, 5 mL 33-9009Accessory kit, holder for pacemaker lead, 1.7 mm 33-9025Basket only assembly, 50-mesh 33-9029Assembly kit, holder basket, 50-mesh 33-9041Assembly kit, PEEK basket 33-9022Basket only assembly, PEEK 33-9042Basket, mesh end, 20 µm 33-9046Assembly, punctal plug holder, 5 mL 33-9047Assembly, contact lens holder, 5 mL 33-9048Assembly, flat blank holder, 10 mL 33-9049Assembly, contact lens holder, 5 mL, 16 mm 33-9050

Did You Know?Agilent offers a variety of standardholders for stents, pacemaker leads,medicated contact lens, wound careproducts, and more. Contact yourAgilent representative for informationon custom-designed holders specificallyfor your testing needs.

Description Part Number400-DS Accessories

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• 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 probeNote: 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 andconversion 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

Rotating Bottle Apparatus andAccessoriesThe 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 isimmersed 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 bottlesprevent 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 externalheater/circulator and provides a stable environment within ± 0.2° C of the set temperature.The standard Rotating Bottle Apparatus includes:

Rotating Bottle

Redesigned Rotating BottleApparatusThe Rotating Bottle Apparatus wasredesigned in 2002 and many of theoriginal accessories are no longermanufactured. Therefore, you mayneed to purchase caps, screens, and/orliners in addition to new bottles.

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Rotating Bottle Apparatus DimensionsHeight Width Depth Weight60.96 cm / 24 in. 48.26 cm / 19 in. 38.86 cm / 15.3 in. 14.1 kg / 31 lb, without

bottles and water bath

Rotating bottle with cap

Rotating Bottle ApparatusDescription Part NumberRotating Bottle Apparatus, with heater/circulator, 115V 30-1000Rotating Bottle Apparatus, with heater/circulator, 230V 30-1100Rotating Bottle Apparatus, without heater/circulator, 115V 30-1200Rotating Bottle Apparatus, without heater/circulator, 230V 30-1300

Rotating Bottle AccessoriesDescription Part NumberConversion KitsConversion kit, amber, 200 mL 32-0110Conversion kit, 4 in. center shaft extensions, 16x100 mm tubes 32-0120Bottle CapsCap, with Viton liner, for 100 mL 32-1101Cap, with Viton liner, for 200 mL 32-1105Decanting cap, with 40-mesh screen, for 100 mL 32-1121Decanting cap, with 40-mesh screen, for 200 mL 32-1125Screens and LinersViton liner, for 100 mL 32-1201Viton liner, for 200 mL 32-1205Replacement screen, for decanting cap, 40-mesh, for 100 mL 32-1221Replacement screen, for decanting cap, 40-mesh, for 200 mL 32-1225ClipsBottle clips, for 100 mL 32-1300Bottle clips, for 16x100 mm tubes 32-1301Bottle clips, for 28x98 mm (40 mL) tubes 32-1302Bottle clips, for 200 mL 32-1305BottlesBottle, with cap, 100 mL 32-5001Bottle, with cap, amber, 100 mL 32-5021Bottle, with cap, amber, 200 mL 32-5030Bottle only, amber, 100 mL 32-5521Bottle only, 100 mL 32-5530

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Dissolution Software

www.agilent.com/lifesciences/dissolutionsoftware

Dissolution Workstation SoftwareComplete, integrated control of multiple dissolutionsystems from a single computer

Dissolution Workstation SoftwareDescription Part NumberDissolution Workstation Software 11-0017

Supported ApparatusAgilent's complete line of dissolutionequipment is available for use withDissolution Workstation Software.

This includes:

• 708-DS, 709-DS and discontinuedapparatus (Apparatus 1 and 2)

• BIO-DIS Reciprocating Cylinder andApparatus 7 Reciprocating Holder(Apparatus 3 and 7)

• 806 Syringe Pump, 808 FilterChanger and 810 Peristaltic Pump

• 8000 Dissolution Sampling Stationand 8020 Dissolution Sampling/HPLCInjector

Dissolution Workstation Software integrates Agilent’s dissolution apparatus and automatedsampling components, allowing you to simultaneously control up to four systems of anyconfiguration 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 singleinterface.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 softwareprogresses through the timepoints for each dissolution system. As part of 21 CFR Part 11compliance, user changes to methods and system configurations can be easily tracked anddocumented.Agilent’s complete line of dissolution equipment is available for use with the DissolutionWorkstation Software. This includes Apparatus 1, 2, 3, 5, 6 and 7 and the associated pumpsand 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 PDF-documented results generated by a dissolution run in the protected database created locallyor on a network. The client-server architecture offers the potential to integrate or export thedata to a laboratory information management system (LIMS).

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Dissolution Software

www.agilent.com/lifesciences/dissolutionsoftware

Dissolution Workstation 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

64

Calibration and Verification Tools

www.agilent.com/lifesciences/calibrationtools

QAII C Mechanical Qualification Station

Measure and document critical physical parameters formost all brands of dissolution apparatus

A specially designed bracket holds a wobble gauge and magnetic tachometer. The wobblegauge displays wobble in millimeters, while the magnetic tachometer records the agitationrate 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 measurementson the vessel plate and drive unit, environmental vibration may also be measured on thelaboratory bench.

QAII C Mechanical Qualification Station

Shaft verticality measurement taken with the QAII CMechanical Qualification Station

The QAII C comes with a certificate of calibration, and annual or biannual recalibration ishighly 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 upgradeallows data capture and retention in 21 CFR Part 11 environments.

Eliminate the guesswork. The digital measurement of physical parameters is easy with theportable, calibrated QAII C Mechanical Qualification Station. Designed for the 21 CFR Part 11environment, the system measures vibration, spindle rotational speed (RPM), shaft and vesselverticality, shaft These highly precise devices are individually calibrated with NIST traceabilityfor reliable mechanical qualification of physical parameters.With the use of the adapter ring and access to the shaft and vessel in operating mode, takingmeasurements of paddles and basket components in a variety of dissolution apparatus frommost manufacturers. Test data printouts from the on-board printer include serial numbers,parameters and space for operator and approval signatures. Alternatively, you may downloadthe data to a Microsoft® Excel spreadsheet to review, approve and retain your mechanicalqualification data.

• 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

The QAII C includes:

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QAII C Mechanical Qualification Station AccessoriesDescription Part NumberQAII C station, 115V 12-0550QAII C station, 230V 12-0560Carrying case, hard plastic 12-0531QAII C calibration, with calibration certificate 12-7500Upgrade, magnetic sensor plus calibration 12-7505Upgrade, QAII to QAII C 12-0580

QAII C Mechanical Qualification Station DimensionsHeight Width Depth Weight18.42 cm / 7.25 in. 22.23 cm / 8.75 in. 19.69 cm / 7.75 in. 2.27 kg /5.3 lb,

without attachments

Vessel verticality measurement with the QAII C

QAII C Mechanical Qualification Station Replacement PartsDescription Part NumberAdapter, universal for QAII and QAII C 12-9005Calibration shaft, with certification 12-9010Reflective RPM sensor clip, black 12-9015Reflective RPM sensor clip, white 12-9020Magnetic RPM sensor clip, for 1/4 dia. shaft 12-9021Magnetic RPM sensor clip, for 3/8 dia. shaft 12-9025Printer paper, 10 rolls/pkg. 12-9995Printer paper, 100 rolls/pkg. 12-9996Ribbon cartridge, 5/pkg. 12-9997

RecalibrationThe QAII C and Agilent 5010 (see page66) should be periodically recalibrated,and Agilent offers this service from theCary, NC facility. To schedule yourinstruments for recalibration, visitwww.agilent.com/lifesciences/dissolution3in1

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Agilent 5010 Height/Center QualificationStation

The Agilent 5010 Height/Center Qualification Station is a portable system for digitallymeasuring shaft centerline offset and paddle/basket height with NIST-traceable gauges. The precision-engineered measuring devices produce highly accurate measurements andensure technicians no longer have to interpret distances or rely on visual estimation commonwith manual gauges.Accurate measuring of shaft centering within the dissolution vessel is easily performed withoutthe 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 anotherand displays the results as measurements are taken. You can also view completed results onthe 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 testthe 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

5010 Height/Center Qualification Station DimensionsHeight Width Depth Weight18.5 cm / 7.25 in. 24.1 cm / 9.5 in. 19.7 cm / 7.75 in. 3 kg / 6.6 lb

Fast and convenient height and centering measurementsrequired by Mechanical Qualification standards

Agilent 5010 Height/Center Qualification StationDescription Part Number5010 Height/Center Qualification Station, with printer, 115/230V 12-0540Carrying case, hard plastic 12-05315010 calibration, with certificate 12-7502

5010 Height Center Qualification Station

Centering measurement (top) and height measurement(bottom) taken with the Agilent 5010.

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Verification Tools

For fast, efficient and manual physical parameter setting verification, Agilent offers several toolsdesigned for use with the 708-DS and 709-DS, as well as older model apparatus still in use.

Height, Centering and Spacer Tools and GaugesEach of these tools ensure your paddles and baskets are set properly for operation. In additionto height and centering, the tools offer correct spacing from the bottom of the dissolutionvessel to the accessory in use such as a paddle or basket.

Shaft Wobble Gauge

Tachometer, HandheldHeight spacer for paddles

Tools to manually set and verify height/depth, wobble,RPM and centering

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.

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.

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Height spacers

A

B C D E

F

Verification ToolsDescription Part NumberHeight Spacers for USP Apparatus 1 and 2Height spacer, for 100 and 200 mL, 3.25 in., for 7000/7010 only(image A) 12-0321Height spacer, for baskets (image B) 12-7210Height spacer, for paddles (image C) 12-7200Height spacer, for paddle and 100 and 200 mL round bottom vessels, 15 mm, for 7000/7010 only

12-0320

Height spacer, for Peak vessels (image D) 12-7220Height spacer, for use with paddles, ball without retrieval string, 25 mm (image E) 12-7240Height spacer, for use with paddles, ball with retrieval string, 25 mm 12-7250Height spacer, for use with paddles, ball with retrieval string, 25 mm, with certificate

12-7250V

Height spacer, for use with intrinsic apparatus, ball with retrieval string, 38 mm 12-7260Height spacer, for use with intrinsic apparatus, ball with retrieval string, 38 mm,with certificate

12-7260V

Height spacer, for attachment to paddles, 25 mm above bottom of vessel 12-7270Height spacer, for attachment to paddles, 25 mm above bottom of vessel, with certificate

12-7270V

Height spacer, for attachment to basket shaft, 25 mm above bottom ofvessel(image F)

12-7280

Height spacer, for attachment to basket shaft, 25 mm above bottom of vessel,with certificate

12-7280V

Height gauge, Rotating Cylinder 12-7335

(Continued)

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(Left to right) Digital gauge, analog gauge andtachometer

Height tools

Vessel centering tools

BA

F G H

CD

E

Height and Centering Tools for USP Apparatus 1 and 2Vessel centering tool, for stainless steel centering ring (image A) 12-7311Vessel centering tool, pass/fail gauge for use with EaseAlign centering rings(image B)

12-7310

Vessel centering tool, pass/fail gauge for use with EaseAlign centering rings, with certificate

12-7310V

Height tool, stainless steel, sets height of basket and paddles, 25 mm (image D) 12-7300Height tool, stainless steel, sets height of basket and paddles, 25 mm, with certificate

12-7300V

Height tool, stainless steel, sets height of basket and paddles, for 2L vessels, 25 mm (image C)

12-7301

Height tool, stainless steel, sets height of basket and paddles, for 2L vessels, 25 mm, with certificate

12-7301V

Height tool, stainless steel, sets height of basket and paddles, used for testingantibiotics, 45 mm

12-7330

Height tool, stainless steel, sets height of basket and paddles, used for testingantibiotics, 45 mm, with certificate

12-7330V

Height tool, stainless steel and Delrin, for Peak vessels (image E) 12-7230Bubble level, for horizontal centering 12-7325Shaft Wobble GaugesDigital wobble gauge, with EaseAlign fitting (image F) 10-2429Analog wobble gauge, 0.01 mm (image G) 12-7020Calibration certificate, for thickness and wobble gauge 12-7520Tachometers and TimerTachometer (image H) 12-7100Calibration certificate, for handheld tachometer 12-7110Calibration certificate, with data sheet, for handheld tachometer 12-7120Calibrated timer, with certificate 12-0040


Verification Tools

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Automated Dissolution Sampling Systems

www.agilent.com/lifesciences/dissolutionsampling

Agilent 8000 Dissolution Sampling StationSimplified and Reproducible Automated DissolutionSample Collection The Agilent 8000 Dissolution Sampling Station provides a proven, reliable solution to set upand execute dissolution tests and automated sampling. Dissolution method parameters areentered and stored in the 8000 while allowing unattended, repeatable sample filtration andcollection according to regulatory requirements. Sampling systems are available in 6-, 8- or12-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 or810 Peristaltic Pump – depending on the volume accuracy, timepoint frequency and thefiltration required for the dissolution samples. Using the 806 Syringe Pump option also allowsfor the addition of the 808 Filter Changer for filtering down to 0.45 µm using 25 mmautomation-friendly filters. All versions of Agilent dissolution apparatus, including Apparatus 1, 2, 3, 5, 6 and 7, as wellas non-Agilent models, can be used with the Agilent 8000, removing analyst samplingvariability 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 consistentvessel volume as samples are removed throughout the dissolution test.

708-DS Dissolution Apparatus, 806 Syringe Pump, 808 Filter Changer and 8000 Dissolution Sampling Station

Agilent 8000 Dissolution Sampling Station with septum-capped vial tray.

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8000 Dissolution Sampling DimensionsHeight Width Depth Weight8000 Dissolution Sampling Station41.28 cm / 16.25 in. 43.18 cm / 17 in. 51.8 cm / 20.38 in. 16.3 kg / 36 lb.806 Syringe Pump29.2 cm / 11.5 in. 24.13 cm / 9.5 in. 15.25 cm / 6 in. 5.8 kg / 12.9 lb.808 Filter Changer45.1 cm / 17.75 in. 24.13 cm / 9.5 in. 44.45 cm / 17.5 in. 14.2 kg / 31.2 lb.810 Peristaltic Pump13.97 cm / 5.5 in. 15.24 cm / 6 in. 45.72 cm / 18 in. 6.9 kg / 15.2 lb

Key Benefits of the 8000 Dissolution Sampling StationMinimize HydrodynamicDisturbance and ImproveSampling Accuracy

Configuring the Agilent 8000 with an Agilent dissolution apparatus andmotorized manifold eliminates the needfor manual sampling and reduceshydrodynamic disturbance from thesampling cannulas. The automatedmanifold is lowered only at the time ofsampling and can be programmed tosample at an exact location based onvessel volume and apparatus installed.

• 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 Station SpecificationsSample 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 mLTest Duration up to 999 hoursNumber of Programs (stored) up to 15Input Voltage 115V / 60Hz or 230V / 50 Hz

72



8000 Dissolution Sampling Station and Accessory Ordering Matrix

Description Voltage # PositionsManifoldConfiguration

810PeristalticPump

806 SyringePump

806 SyringePump/808 FilterChanger

Ordering an Agilent 8000 forconfiguration with a 7000/7010. The sampling manifold and motordrive are included. The configurationof the sampling manifold is based onthe vessel positions of your 7000 or7010.

115V 6-Valve 3 x 3 15-1000 15-7000 15-20004 x 2 15-1020 15-7020 15-2020

8-Valve 4 x 4 15-1500 15-7040 15-2400230V 6-Valve 3 x 3 15-1100 15-7100 15-2100

4 x 2 15-1120 15-7120 15-21208-Valve 4 x 4 15-1500 15-7140 15-2500

Ordering an Agilent 8000 forconfiguration with a 705-DS*, 708-DS*, 7025/7030, or non-Agilent apparatus**

115V 6-Valve N/A 15-3600 15-3620 15-36408-Valve N/A 15-3610 15-3630 15-3650

230V 6-Valve N/A 15-3660 15-3680 15-37008-Valve N/A 15-3670 15-3690 15-3710

Ordering an Agilent 8000 forconfiguration with a BIO-DISReciprocating Cylinder orReciprocating HolderApparatus 7

115V 8-Valve N/A 15-1410 15-7155 15-241012-Valve N/A 15-1441

230V 8-Valve N/A 15-1420 15-7165 15-242012-Valve N/A 15-1442

Include the appropriate accessory kit part number below to accompany the 8000:8000 Accessory Kit – includes sample tray, Full FlowFilter sample packs, package of test tubes/vials

6 or 8-Valve 16 x 100 mm Tray 1001-101712 x 32 mm Tray 1001-1018

12-Valve 12 x 32 mm Tray 1001-1020*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-DSwith 6 positions, set up for paddles andbaskets, DDM option, 8000 DissolutionSampling Station, 806 Syringe Pump, 808 Filter Changer at 230V. Note: The AutoTemp option is standard on the 709-DS.

709-DS and Autosampling Ordering ExampleQuantity Description Part Number1 709-DS system, DDM, sampling and temperature, 6-position 16-76001 8000, 6-valve, with 806 Syringe Pump / 808 Filter Changer, 230V 15-37001 8000 accessory kit with 16x100 mm sample tray, Full Flow Filter

sample packs, package of test tubes/vials, 6-or 8-valve1001-1017

6 Paddle, lower interchangeable, electropolished stainless steel 12-14216 Basket shaft clip, lower interchangeable, standard USP 12-14306 Basket, USP, 40-mesh, 381 µm 12-2100

The Agilent 8000 may be configured with a peristaltic pump, syringe pump, or syringe pump with filter changer. Use the following OrderingMatrix to select the appropriate part number based on voltage, number of positions, manifold configuration (if applicable) and desired pumpcomponents. 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.

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Enabled for use with the 705-DS, 708-DS, 7025, and 7030 Dissolution Apparatus8000, 6-valve, with 810 Peristaltic Pump, 115V 15-36008000, 6-valve, with 810 Peristaltic Pump, 230V 15-36608000, 8-valve, with 810 Peristaltic Pump, 115V 15-36108000, 8-valve, with 810 Peristaltic Pump, 230V 15-36708000, 6-valve, with 806 Syringe Pump, 115V 15-36208000, 6-valve, with 806 Syringe Pump, 230V 15-36808000, 8-valve, with 806 Syringe Pump, 115V 15-36308000, 8-valve, with 806 Syringe Pump, 230V 15-36908000, 6-valve, with 806 Syringe Pump / 808 Filter Changer, 115V 15-36408000, 6-valve, with 806 Syringe Pump / 808 Filter Changer, 230V 15-37008000, 8-valve, with 806 Syringe Pump / 808 Filter Changer, 115V 15-36508000, 8-valve, with 806 Syringe Pump / 808 Filter Changer, 230V 15-3710Enabled for use with the 7000 and 7010 Dissolution Apparatus8000, 3x3, 6-valve, with 810 Peristaltic Pump, 115V 15-10008000, 4x2, 6-valve, with 810 Peristaltic Pump, 115V 15-10208000, 3x3, 6-valve, with 810 Peristaltic Pump, 230V 15-11008000, 4x2, 6-valve, with 810 Peristaltic Pump, 230V 15-11208000, 4x4, 8-valve, with 810 Peristaltic Pump, 115V 15-14008000, 4x4, 8-valve, with 810 Peristaltic Pump, 230V 15-15008000, 3x3, with 806 Syringe Pump, 115V 15-70008000, 4x2, with 806 Syringe Pump, 115V 15-70208000, 4x4, with 806 Syringe Pump, 115V 15-70408000, 3x3, with 806 Syringe Pump, 230V 15-71008000, 4x2, with 806 Syringe Pump, 230V 15-71208000, 4x4, with 806 Syringe Pump, 230V 15-71408000, 3x3, with 806 Syringe Pump / 808 Filter Changer, 115V 15-20008000, 4x2, with 806 Syringe Pump / 808 Filter Changer, 115V 15-20208000, 3x3, with 806 Syringe Pump / 808 Filter Changer, 230V 15-21008000, 4x2, with 806 Syringe Pump / 808 Filter Changer, 230V 15-21208000, 4x4, with 806 Syringe Pump / 808 Filter Changer, 115V 15-24008000, 4x4, with 806 Syringe Pump / 808 Filter Changer, 230V 15-25008000, 3x3 for 2L, with 806 Syringe Pump, 115V 15-80308000, 3x3 for 2L, with 806 Syringe Pump, 230V 15-80358000, 4x4 for 2L, with 806 Syringe Pump, 115V 15-80408000, 4x4 for 2L, with 806 Syringe Pump, 230V 15-8045

Description Part Number8000 Dissolution Sampling Station and Sampling System

(Continued)

Did You Know?Several vessel plate configurationswere available with the 7000/7010Dissolution Apparatus. To helpdistinguish:3x3 – indicates 2 rows of 3 vessels4x2 – indicates 2 rows of 4 vessels

with 6 active spindle locations(back 2 middle positions empty)

4x4 – indicates 2 rows of 4 vesselswith 8 active spindle locations

74



Acrylic rinse trays

Sampling trays with HPLC septum-capped vials (top) and glass tubes (bottom).

Enabled for use with the BIO-DIS Reciprocating Cylinder Apparatus8000, 8-valve, for BIO-DIS, with 810 Peristaltic Pump, 115V 15-14108000, 8-valve, for BIO-DIS, with 810 Peristaltic Pump, 230V 15-14208000, 4x4, for BIO-DIS, with 806 Syringe Pump, 115V 15-71558000, 4x4, for BIO-DIS, with 806 Syringe Pump, 230V 15-71658000, 8-valve, for BIO-DIS, with 806 Syringe Pump / 808 Filter Changer, 115V 15-24108000, 8-valve, for BIO-DIS, with 806 Syringe Pump / 808 Filter Changer, 230V 15-2420Enabled for use with the Reciprocating Holder Apparatus 7 and Custom 12-Tube Apparatus 78000, 12 valve, with 810 Peristaltic Pump, for App. 7, 115V 15-14418000, 12-valve, with 810 Peristaltic Pump, for App. 7, 230V 15-1442Accessories for 8000 Dissolution Sampling StationMedia replacement option, internal (specify printer type) 17-0110Media/rinse chamber 17-1200Printer, retrofit kit 17-1400Stacking rack, for 8000 17-1500Autocalibration fixture 17-5100810 Peristaltic Pump replacement cartridge 17-6020Dual loop, 810 Peristaltic Pump kit with 6 cartridges 17-6021Dual loop, 810 Peristaltic Pump kit with 8 cartridges 17-6022Adapters, to connect Teflon to 810 Peristaltic Pump tubing, 24/pkg. 17-6050Nut and ferrule, 1/4-28, for 1/16 in. inner dia. Tubing 17-6070Trays for 8000 Dissolution Sampling StationSampling tray, open tube, 16x100 mm 17-1000Sampling tray, open tube, 15x100 mm 17-1010Sampling tray, open tube, 15x85 mm 17-1015Sampling tray, HPLC, 8x30 mm 17-1020Sampling tray, HPLC, 7x40 mm 17-1030Sampling tray, HPLC, 8x40 mm 17-1040Sampling tray, HPLC, 12x32 mm 17-1050Sampling tray, HPLC, 15x45 mm, for 8020 only 17-1060Sampling tray, HPLC, 12x32 mm, for 8020 only 17-1061Sampling tray, HPLC, 15x45 mm 17-1065Sampling tray, HPLC, 13x75 mm 17-1070Sampling tray, HPLC, 13x100 mm 17-1075Sampling tray, HPLC, 12x75 mm 17-1080Acrylic rinse tray, 6 vessels, 3x3, for 7000/7010 17-1300Acrylic rinse tray, 7-8 vessels, for 7000/7010 17-1310Acrylic rinse tray, for 708-DS/709-DS 17-1351

Description Part Number8000 Dissolution Sampling Station and Sampling System

(Continued)

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HPLC septum-capped vials (top) and glass tubes (bottom)

Replacement Accessories for 8000 Dissolution Sampling StationSampling cannula, 4.5 in. (for 7000/7010 manifold) 17-3300Sampling cannula, 6.5 in., for 500 mL in 1L vessel (for 7000/7010 manifold) 17-3305Cannula extension kit, 500 mL (for one cannula) 17-3306Sampling cannula, 8.12 in., for 2L vessel (for 7000/7010 manifold) 17-3307Sampling cannula, 10 in., for 4L vessel (for 7000/7010 manifold) 17-3309Adapter, manual sampling cannula, for PNs 17-3311 and 17-3312 17-3310Manual sampling cannula assembly, 500 mL 17-3311Manual sampling cannula assembly, 900 mL 17-3312Sampling cannula, for 7025/7030 17-3313Return cannula, for 7025/7030 17-3314Manual sampling cannula, for sampling through apparatus head on 7025/7030 17-3317Return cannula, 2 1/4 in. 17-3320

Glass tubes, 16x100 mm, 250/pkg. 17-5001Glass tubes, 15x85 mm, 1000/pkg. 17-5010Glass vial, clear, 12x32, with cap, PTFE/silicon, 100/pkg. 17-5020Glass vial, clear, with PTFE/silicon cap, 15x45, 100/pkg. 17-5030Glass vial, amber, with PTFE/silicon cap, 15x45, 100/pkg. 17-5035Calibration tubes, 10 mL, 8/pkg. 17-5040Replacement needles, long, 3/pkg. 17-6100Replacement needles, short, 3/pkg. 17-6110Replacement valve kit, long needle 17-6200Replacement valve kit, short needle 17-6210Replacement Tubing for 810 Peristaltic PumpPurple/white Marprene replacement tubing, 8/pkg. 17-6000Purple/white Viton replacement tubing, 8/pkg. 17-6005White silicone replacement tubing, 8/pkg. 17-6010Replacement Colored Tubing for Peristaltic/Syringe Pumps (without fittings)Tubing, colored Teflon, for 3x3, for use with 810 Peristaltic Pump, 0.042 in. dia., 6 lengths of 50 ft.

17-6030

Tubing, colored Teflon, for 4x2, for use with 810 Peristaltic Pump, 0.042 in. dia., 6 lengths of 50 ft.

17-6031


17-6035

Tubing, colored Teflon, for 3x3, for use with 806 Syringe Pump, 0.032 in. dia., 6 lengths of 50 ft.

17-6038

Tubes, Vials and Needles for 8000 Dissolution Sampling Station


8000 Dissolution Sampling Station and Sampling System

(Continued)

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Tubing assembly, 2L, sampling cannula valve, 3x3 1005-1782Tubing assembly, 2L, return cannula valve, 3x3 1005-1783Tubing assembly, 2L, return cannula, 8-valve, for Cary 50 1005-1784Tubing assembly, sampling cannula, 8-valve, for Cary 50 1005-1785

Tubing assembly, flared, sampling cannula, 8-valve 1005-1670Tubing assembly, flared, return cannula, 8-valve 1005-1671Tubing assembly, flared, return, 8-valve 1005-1672Tubing assembly, flared, sampling, 8-valve 1005-1673Tubing assembly, flared, sampling, 8-valve, for 810 Peristaltic Pump 1005-1674Tubing assembly, flared, sampling cannula valve, 3x3 1005-1687Tubing assembly, flared, return cannula valve, 3x3 1005-1688Tubing assembly, flared, sampling cannula valve, 4x2 1005-1692Tubing assembly, flared, return cannula valve, 4x2 1005-1693Tubing assembly, flared, return 6-valve 1005-1694Tubing assembly, flared, sampling 6-valve 1005-1695Tubing assembly, flared, pump to 6-valve 1005-1696Tubing assembly, flared, for 806 Syringe Pump / 808 Filter Changer, 6-valve 1005-1722Tubing assembly, flared, for 806 Syringe Pump / 808 Filter Changer, 8-valve 1005-1729Tubing assembly, 2L, sampling cannula valve, 4x2 1005-1778Tubing assembly, 2L, return cannula valve, 4x2 1005-1779Tubing assembly, 2L, sampling cannula, 8-valve 1005-1780Tubing assembly, 2L, return cannula, 8-valve 1005-1781

Tubing assembly, sampling/return, 8-valve, for 7025/7030 1005-1786Tubing assembly, sampling/return, 6-valve, for 7025/7030 1005-1787Tubing assembly, return cannula, 12x12, for BIO-DIS 1005-1788Tubing assembly, sampling cannula, 12x12, for BIO-DIS 1005-1789Tubing assembly, male/female, 12x12, for BIO-DIS 1005-1790Tubing assembly, male lure for 810 Peristaltic Pump, 12x12, for BIO-DIS 1005-1791Tubing assembly, return valve, 12x12, for BIO-DIS 1005-1792Tubing assembly, barbed fitting, 12x12, for BIO-DIS 1005-1793Tubing assembly, sampling valve, 12x12, for BIO-DIS 1005-1794Tubing assembly, 1L, sampling cannula, 6-valve, for 708-DS 1005-1881Tubing assembly, 1L, return cannula, 6-valve, for 708-DS 1005-1882Tubing assembly, 1L, sampling cannula, 8-valve, for 708-DS 1005-1883Tubing assembly, 1L, return cannula, 8-valve, for 708-DS 1005-1884Tubing assembly, 2L, sampling cannula, 6-valve, for 708-DS 1005-1885Tubing assembly, 2L, return cannula, 6-valve, for 708-DS 1005-1886Tubing assembly, 2L, sampling cannula, 8-valve, for 708-DS 1005-1887Tubing assembly, 2L, return cannula, 8-valve, for 708-DS 1005-1888

Color-coded Clear Tubing for 8000 Dissolution Sampling StationDescription Part Number


(Continued)

77



Tubing assembly, 8 flared, male to female, 72 in. 1005-1891Tubing assembly, 6 flared, male to female, 72 in. 1005-1892Tubing assembly, 8 double flared, male to male, 72 in. 1005-1893Tubing assembly, 6 double flared, male to male, 72 in. 1005-1894Tubing assembly, sampling cannula valve, 3x3, 200 mL 1005-1901Tubing assembly, return cannula valve, 3x3, 200 mL 1005-1902Tubing assembly, sampling cannula valve, 4x2, 200 mL 1005-1903Tubing assembly, return cannula valve, 4x2, 200 mL 1005-1904Tubing assembly, sampling cannula valve, 4x4, 100 mL 1005-1905Tubing assembly, return cannula valve, 4x4, 100 mL 1005-1906Tubing assembly, sampling cannula valve, 4x2, 100 mL 1005-1907Tubing assembly, return cannula valve, 4x2, 100 mL 1005-1908Tubing assembly, for 1L 708-DS, sample and return cannulas, 6-position 1005-1920Tubing assembly, for 1L 708-DS, sample and return cannulas, 8-position 1005-1921Tubing assembly, for 2L 708-DS, sample and return cannulas, 6-position 1005-1922Tubing assembly, for 2L 708-DS, sample and return cannulas, 8-position 1005-1923Tubing assembly, sampling cannula valve, 3x3, 100 mL 1005-1945Tubing assembly, return cannula valve, 3x3, 100 mL 1005-1946Tubing assembly, female/lure to sample cannula, 8-valve, for BIO-DIS 1005-1952Tubing assembly, male/lure to male ¼-28, 8-valve, for BIO-DIS 1005-1953Tubing assembly, female ¼-28 to return cannula, 8-valve, for BIO-DIS 1005-1954

Color-coded Clear Tubing for 8000 Dissolution Sampling StationDescription Part Number


8000 Dissolution Sampling Station – Base Station only (no pump)Description Part Number8000 Dissolution Sampling Station, 6-valve, 115V 15-40008000 Dissolution Sampling Station, 8-valve, 115V 15-44008000 Dissolution Sampling Station, 6-valve, 230V 15-41008000 Dissolution Sampling Station, 8-valve, 115V 15-4500

78



Agilent 806 Syringe Pump

The Agilent 806 Syringe Pump draws samples from an Agilent dissolution and drug releaseapparatus and ensures precise sample volumes. The Agilent 806 utilizes completely inertsample contact materials consisting of stainless steel, glass, Teflon and PEEK materials.

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 samplingtimepoints 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 notrequired. The 806 Syringe Pump with 8000 Dissolution Sampling Station may also beconfigured with a non-Agilent instrument to automate dissolution sampling using a residentprobe setup.

806 Syringe PumpDescription Part Number806 Syringe Pump, 8-channel, 115V 15-5100806 Syringe Pump, 6-channel, 115V 15-5101806 Syringe Pump, 8-channel, 230V 15-5110806 Syringe Pump, 6-channel, 230V 15-5111

• 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 Dimensions and SpecificationsHeight Width Depth Weight29.2 cm / 11.5 in. 24.13 cm / 9.5 in. 15.25 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

806 Syringe Pump

79



Agilent 808 Filter Changer

The dissolution process does not stop until all undissolved drug has been removed from thesample. 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 linessimultaneously and can store up to 200 filters at a time. The filters are automatically changedbetween timepoints to prevent filter clogging. The Agilent 808 is used in conjunction withthe 806 Syringe Pump and can easily be added to an existing configuration that includes the8000 Dissolution Sampling Station.

Combining the 808 Filter Changer with 8000 Dissolution Sampling Stationand 806 Syringe PumpWhen 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 Dimensions and SpecificationsHeight Width Depth Weight45.1 cm / 17.75 in. 24.13 cm / 9.5 in. 44.45 cm / 17.5 in. 14.2 kg / 31.2 lb.Sampling Accuracy (with Agilent 8000 and 806 Syringe Pump)± 0.3 mL for 10 mL sample

808 Filter ChangerDescription Part Number808 Filter Changer, 8-channel, 115V 15-5002808 Filter Changer, 6-channel, 115V 15-5004808 Filter Changer, 8-channel, 230V 15-5006808 Filter Changer, 6-channel, 230V 15-5008

808 Filter Changer

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Agilent 810 Peristaltic Pump

The flexible, bi-directional Agilent 810 Peristaltic Pump has a 16-channel maximum capacityfor sample transfer in Agilent dissolution sampling systems. The 8-roller design creates asmooth flow while priming, sampling, and purging the sampling lines. Sample movement isaccomplished 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 forautomated sample volume accuracy of ± 0.5 mL. The autocalibration block ensures the volume accuracy for each line without regard tochanges in the tubing. By timing how long it takes to fill a specific volume, the 8000 canaccurately dispense based on the time specific to each line. The 810 Peristaltic Pump comes standard with Marprene tubing with an inside diameter of 0.110 in. and adjustable pump cartridges. Silicone and Viton tubing and replacementcartridges 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

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Cartridges for 810 Peristaltic Pump

810 Peristaltic Pump DimensionsHeight Width Depth Weight13.97 cm / 5.5 in. 15.24 cm / 6 in. 45.72 cm / 18 in. 6.9 kg / 15.2 lb.Sampling Accuracy± 0.5 mL for 10 mL sample

Agilent 810 Peristaltic PumpDescription Part Number810 Peristaltic Pump, 6-channel, 115V 17-2000810 Peristaltic Pump, 6-channel, 230V 17-2100810 Peristaltic Pump, 8-channel, 115V 17-2200810 Peristaltic Pump, 8-channel, 230V 17-2300810 Peristaltic Pump, 16-channel, 115V 17-2600810 Peristaltic Pump, 16-channel, 230V 17-2700Peristaltic Replacement Cartridge810 Peristaltic Pump replacement cartridge 17-6020Peristaltic Replacement TubingPurple/white Marprene replacement tubing, 8/pkg. 17-6000Purple/white Viton replacement tubing, 8/pkg. 17-6005White silicone replacement tubing, 8/pkg. 17-6010Colored Teflon Tubing, 50 ft. lengths, for 810 Peristaltic PumpTubing, colored Teflon, for 3x3, for use with 810 Peristaltic Pump, 0.042 in. dia., 6 lengths of 50 ft.

17-6030


17-6031


17-6035

82



Agilent 8020 Dissolution Sampling/HPLCInjector

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 usingDissolution Workstation software. The 8020 can be paired with Agilent’s dissolutionapparatus, 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. Injectionsonto the LC column occur between sampling timepoints. Sample collection always takesprecedence over sample injections to ensure sampling accuracy meets pharmacopeialrequirements. During a sample point, the injector module goes into standby mode, returning to its task only at the end of the timepoint.

8020 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

• 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

The standard 8020 Dissolution Sampling/HPLC Injector includes:

8020 Dissolution Sampling/HPLC Injector

83



8020 Dissolution Sampling Station/HPLC Injector DimensionsHeight Width Depth Weight8020 Dissolution Sampling Station43.69 cm / 17.2 in. 43.18 cm / 17 in. 51.8 cm / 20.38 in. 17.2 kg / 38 lbHPLC Injector34.29 cm / 13.5 in. 33.66 cm / 13.25 in. 45.72 cm / 18 in. 9.4 kg / 20.8 lb

Agilent 8020 Dissolution Sampling/HPLC InjectorDescription Part Number8020 Dissolution Sampling Injector for 7000/7010 Dissolution Apparatus8020, 6-valve, with 810 Peristaltic Pump, 115V 20-66708020, 6-valve, with 810 Peristaltic Pump, 230V 20-66758020, 6-valve, with 806 Syringe Pump, 115V 20-67008020, 6-valve, with 806 Syringe Pump, 230V 20-67058020, 6-valve, with 806 Syringe Pump / 808 Filter Changer, 115V 20-67208020, 6-valve, with 806 Syringe Pump / 808 Filter Changer, 230V 20-67258020, 8-valve, with 810 Peristaltic Pump, 115V 20-63008020, 8-valve, with 810 Peristaltic Pump, 230V 20-63108020, 8-valve, with 806 Syringe Pump, 115V 20-65808020, 8-valve, with 806 Syringe Pump, 230V 20-65858020, 8-valve, with 806 Syringe Pump / 808 Filter Changer, 115V 20-66508020, 8-valve, with 806 Syringe Pump / 808 Filter Changer, 230V 20-66558020 Dissolution Sampling Injector for 708-DS and 7025 Dissolution Apparatus8020, 8-valve, with 810 Peristaltic Pump, 115V 20-65108020, 8-valve, with 810 Peristaltic Pump, 230V 20-65158020, 8-valve, with 806 Syringe Pump, 115V 20-65408020, 8-valve, with 806 Syringe Pump, 230V 20-65458020, 8-valve, with 806 Syringe Pump / 808 Filter Changer, 115V 20-66108020, 8-valve, with 806 Syringe Pump / 808 Filter Changer, 230V 20-66158020, 6-valve, with 810 Peristaltic Pump, 115V 20-66808020, 6-valve, with 810 Peristaltic Pump, 230V 20-66858020, 6-valve, with 806 Syringe Pump, 115V 20-66908020, 6-valve, with 806 Syringe Pump, 230V 20-66958020, 6-valve, with 806 Syringe Pump / 808 Filter Changer, 115V 20-67108020, 6-valve, with 806 Syringe Pump / 808 Filter Changer, 230V 20-67158020 Injector8020 Injection module, 115/230V 20-6200Note: An 8020 configured with the 806 Syringe Pump requires use of the Dissolution Workstation Software. See page 62 forordering information.

84 www.agilent.com/lifesciences/UVdissolution

Automated UV Dissolution Systems

UV Dissolution SystemsSelecting a UV Dissolution System

Agilent offers UV Dissolution Systems with both the 8453 UV-visible Spectrophotometer andthe 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 tosuit your needs.

Online UV Dissolution System Configuration

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 optioncan have up to four apparatus integrated with one UV spectrophotometer. Samples arewithdrawn and read sequentially. After measurement, the sample is discarded as opposedto 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 dual-apparatus configuration, each vessel has a dedicated flow cell. Samples are takensimultaneously 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 ofsamples as they are read.

• Fiber Optic UV Dissolution: May be configured for use with a 12-channel fiber opticmultiplexer, and integrated with either one or two apparatus. The fiber optic probes aremounted on the moveable manifold and are only in the media during measurementtimepoints.

If you need assistance with selecting the system most suitable for your laboratory, pleasecontact your Agilent representative.

1. Select the UV spectrophotometer that best suits your testing needs. Some important criteria totake into account:

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.

85www.agilent.com/lifesciences/UVdissolution


UV Dissolution Selection Chart8453 and Cary 60 UV-visible Spectrophotometers

General Information 8453 Cary 60Software Package ChemStation Cary WinUVNumber of Apparatus 1 to 4 (Valve System) 1 to 2Multicomponent Analysis Yes NoFiber Optic System Availability No Yes

SpectrophotometerDetails

8453 Cary 60

Wavelength Range 190-1100 nm 190-1100 nmSlit Width 1 nm 1.5 nmLamp Type Tungsten and Deuterium Xenon FlashInstrument Design Diode Array ScanningWavelength Accuracy < ± 0.5 nm < ± 0.5 nmWavelength Reproducibility < ± 0.02 nm ± 0.1 nmPhotometric Accuracy < ± 0.005 Abs (NIST 930E) ± 0.005 Abs (NIST 930D)Photometric Noise < 0.0002 Abs ± 0.0001 AbsBaseline Flatness < 0.001 Abs < 0.001 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 SystemDetails

8453 Cary 60

Closed Loop Sampling Yes (Multicell) Yes (Multicell)

Maximum Path Length (mm) 50 (Multicell) 10 (Multicell) 20 (Fiber Optic)

Automated Dosage Delivery and Sampling

Yes Yes

Temperature Monitoring Yes YesSimultaneous Sampling Yes (Multicell) Yes (Multicell)Sequential Sampling Yes (Valve Systems) Yes (Fiber Optic)Sample Filtration (minimum poresize µm)

5 µm 0.45 µm (with 808 FilterChanger)

Sample Archival No Yes (Multicell with 8000Dissolution Sampling Station)



UV-visible SoftwareDetails

8453(ChemStation)

Cary 60 (Cary Win UV)

Real-time Data Visible Yes YesIndependent Methods Yes YesOffline Analysis Yes YesUser-definable DissolutionResult Calculation

Yes No

Tablet Weight Normalization Yes YesMedium Volume Changes Yes YesCustomizable Reports Yes YesApparatus Performance Tracking Yes No21 CFR Part 11 Package Yes YesElectronic Signatures Yes Yes

Select from either of Agilent's UV-Vis Spectrophotometers for a complete online solution – 8453 UV-Vis (left) or Cary 60 (right)



Agilent 8453 UV Dissolution SystemsOnline UV Dissolution

Agilent, Varian and VanKel dissolution apparatus can be directly linked to the diode arrayAgilent 8453 UV-visible spectrophotometer for automated test runs. The UV-visibleChemStation 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 methoddevelopment and validation, as well as a tool set for 21 CFR Part 11 compliance.

Online Sampling SystemsThe ChemStation software controls the sampling and pumping systems, or you can choose tomanually operate the systems. The pumps, with convenient cassette-mounted tubing, offervariable speeds for adjustable flow rates, which are reversible as well.The online sampling systems support eight measurement channels depending on thehardware 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 combinationwith the variable pump times are ideal for aligning your target UV-visible analysis. You canadapt 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



8453 UV Dissolution System: Multicell-based Sampling

8453 UV Dissolution System: Multicell-based SamplingThe multicell-based system is the most commonly used and versatile sampling system for single apparatus testing, and is ideally suited for QAtesting and formulation development. The system uses a multicell transport with eight flow cells, one for the blank, up to six for the individualvessels 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 alarge number of data points, allowing for a well characterized dissolution profile.

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.

1

2

3

Flow Configuration (as shown below)



8453 UV Dissolution System: Valve-based Sampling

8453 UV Dissolution System: Valve-based SamplingThe valve-based system is the most cost-effective UV dissolution solution. The system uses an eight-port valve to switch between blank, controland 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.

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.

23

4




8453 UV Dissolution System: Multi-apparatus SamplingThe Agilent 8453 UV dissolution testing system, in combination with the valve-based, multi-apparatus sampling capabilities, offers increasedproductivity when running a large number of samples. The system uses a single spectrophotometer to measure a blank, six vessels and a controlin up to four apparatus all within five minutes, and each apparatus can run a different method, if needed. The methods and features are identicalwith the single-apparatus, valve-based system. In both systems the samples are read sequentially. Each apparatus has a dedicated flow cell.

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 thelowered position during the sampling process.

1 1 1 1

2

4

3

8453 UV Dissolution System: Multi-apparatus Sampling




Sipper operation is easy with built-in measurementbuttons.

Agilent 8453 UV Dissolution SystemsOffline UV Dissolution

In the offline approach of UV dissolution testing, the dissolution samples are collectedindependently of the 8453 UV-visible spectrophotometer. For example, a number of dissolutionapparatus can be used in conjunction with an automated sampling system. The samples arethen transported to the 8453 for analysis. Sample analysis and data evaluation are performedusing 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 scalableand applies to:

• 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 rightsequence 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 asignificant automation and an optimum utilization of the spectrophotometer.

8453 UV-Visible Spectrophotometer Dimensions Height Width Depth Weight18.5 cm / 7.3 in. 34.4 cm / 13.5 in. 56 cm / 22 in. 16.5 kg / 36.3 lbs.



UV-Vis ChemStation Software

The UV-Visible ChemStation software belongs to Agilent’s family of ChemStation software foranalytical instruments, and its portfolio of features facilitates a strong learning and usabilityexperience.The application module for dissolution testing offers precise and accurate sample analysiscombined with online and offline dissolution testing analysis and results evaluation. AChemStation dissolution testing method is generated independent from the approach ofsampling. This offers new opportunities in method transfer even if different approaches in theexperimental setup and equipment are applied. A ChemStation dissolution method supportsthe dissolution workflow from test preparation to the final clean-up and results archival.In its online configuration, the ChemStation dissolution software monitors and checks theapparatus performance during a dissolution testing run. The results file generated after testcompletion contains all information to verify, reprocess and document the dissolutionexperiment. The ChemStation’s Security Pack provides the necessary 21 CFR Part 11requirement tools without the need of a database. Electronic signatures can be issued on aresults file for various purposes.Apparatus drivers, ChemStation software and the dissolution application module are requiredto control your dissolution apparatus.

Did You Know?ChemStation’s dissolution softwaresupports full spectrum acquisition.During a dissolution run, correctionscan be applied for capsule absorbanceand background scattering. Multi-component analysis of formulationswith multiple active ingredients canalso be analyzed. Analytical methodscan be optimized without repeating the test run simply by recalculation ofthe run data.

The run-time display shows profiles, actual values and thelast spectra, as well as the status of instrument at aglance.

Dissolution with the 8453 UV-visible SpectrophotometerDescription Part Number8453 UV-visible SystemAgilent 8453 UV-visible value system G1812AAAgilent 8453 UV-visible pharma system G1815AAUV-visible ChemStation Dissolution SoftwareDissolution testing software G1118AADissolution apparatus driver software for Agilent, Varian and VanKel Apparatus 1 and 2

G7900AA

Automated Sipper System for 8453 89068D8453 Sampling SystemsXY Autosampler G1811AMulticell Transport Sampling System G1127AValve Sampling System G1128AMultibath sampling system for two dissolution apparatus G1129AAdditional sampling system for one dissolution apparatus G1130A



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 asstandard.

The three bundles, which all offer automated runs analyzed by the 8453 UV-visibleSpectrophotometer, include:

8453 UV Dissolution System BundlesDescription Part Number8453 UV Dissolution SystemValue 8453 UV Dissolution System G7920A� 708-DS Dissolution Apparatus� Valve-based sampling system with 8453 UV-visible Spectrophotometer� PC and printer� UV-visible ChemStation plus Security Pack softwareMulti-apparatus 8453 UV Dissolution System G7921A� Two 708-DS Dissolution Apparatus� Multi-apparatus sampling system with 8453 UV-visible Spectrophotometer � PC and printer� UV-visible ChemStation plus Security Pack softwareResearch 8453 Dissolution System G7922A� 708-DS Dissolution Apparatus� Multicell-based sampling system with 8453 UV-visible Spectrophotometer� PC and printer� UV-visible ChemStation plus Security Pack software8453 UV Dissolution System Options8453 UV Dissolution System without printer G792xA#8908453 UV Dissolution System without PC and printer G792xA#8808453 UV Dissolution System without 708-DS apparatus G792xA#900Replace 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 kitis not available with the 709-DS. Eight 1L clear glass vessels are included instead.Should you require further customization (example: amber vessels, 2L vessels, rotatingcylinders, etc.), Agilent can easily custom configure your apparatus. Contact your Agilentrepresentative for details.

For a custom dissolution system, you may also create a 708-DS or 709-DS that meets yourspecific needs and order the individual system components from the table on page 94.



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-DSApparatus for use with8453 UV-VisSpectrophotometers

8453 withSingleApparatus –Multicell

8453 with SingleApparatus ValveSetup

8453 with Multi-apparatus System

708-DS standaloneapparatus – withoutmanifold

16-62001 andResident Probe Kit2



G1815AA G1815AA G1815AAG1118AA G1118AA G1118AAG7900AA G7900AA G7900AAG1127A G1128A G1129A3

708-DS withAutosampling only

16-65001 16-65001 16-65001


708-DS withAutosampling andAutoTemp

16-68001 16-68001 16-68001


708-DS withAutosampling,AutoTemp and DDM

16-71001 16-71001 16-71001


709-DS withAutosampling andAutoTemp

16-75002 16-75002 16-75002


709-DS withAutosampling, AutoTempand DDM

16-77001 16-77001 16-77001


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 21.3 Supports two (2) dissolution apparatus. Add G1130A for each additional apparatus, up to four (4).



Agilent Cary 60 UV Dissolution SystemOnline UV Dissolution – MulticellPrecise and accurate determination of dissolution concentrations is achieved with UV methods. These remain among one of the most commonanalytical techniques for dissolution sample analysis. Agilent’s Online UV Dissolution System with the Cary 60 UV-visible Spectrophotometerintegrates 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 takeboth blank and standard readings during each timepoint. Additionally, each vessel position is configured with its own flow cell and tubing,eliminating cross-contamination.

1

1

1 2

2

2

3

3

3

Cary 60 UV Dissolution System – Single Apparatus Setup with 810 Peristaltic Pump

Prime PurgeRead

Before Sampling Aftersampling cannula

return cannula

SamplingPrime Purge

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.

Cary 60 UV Dissolution System: Single Apparatus with 810 Peristaltic PumpThe 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 thevessel maintaining vessel volume and eliminating the need for media replacement. Should you wish to retain a sample, the 8000 Dissolution SamplingSystem can be used in conjunction with the spectrophotometer. The sample will be read and a portion retained for failure investigation if needed.



1 2 3

5

43

3

2

2

1

1

Sampling

sampling cannula

full flow filter

return cannula

Prime Purge

AfterSamplingBefore

Cary 60 UV Dissolution System – Single Apparatus Setup with 806 Syringe Pump, 808 Filter Changer and 8000 Dissolution Sampling Station

Cary 60 UV Dissolution System: Single Apparatus with 806 Syringe Pump, 808 Filter Changer and 8000 Sampling StationThe multicell system is ideal for providing repeatable results, especially when 0.45 µm filtering or sample archival is required, via the 808 FilterChanger and 8000 Dissolution Sampling Station. Integrating the 8000 with the Cary 60 allows you the flexibility of online UV analysis and offlinecollection 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.



Cary 60 UV Dissolution System – Dual Apparatus Setup with 810 Peristaltic Pumps

1

1

2 2

2

2 3

3 3

31

1

Before Sampling

Sampling

Aftersampling cannula

full flow filter

return cannula

Prime Purge

Prime PurgeRead

Cary 60 UV Dissolution System: Dual Apparatus with 810 Peristaltic PumpsFor maximum efficiency, up to two dissolution apparatus can be used with a single Cary 60. A dual apparatus system will incorporate two pumpsto allow independent methods to be run on the two systems. A dual system may include any combination of dissolution apparatus and samplingequipment 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 cellchanger of the Cary 60 has the capacity to support two sets of dedicated flow cells, eliminating the chance of cross-contamination or carryover.



Cary 60 UV-visible Spectrophotometer with multiplexerfor fiber optic UV dissolution

Agilent Cary 60 UV-Vis SpectrophotometerOnline UV Dissolution – Fiber Optic

The Fiber Optic Online UV Dissolution System offers versatility and flexibility while deliveringthe highest level of automation and data integration for your UV dissolution needs. The Cary60 UV-visible spectrophotometer offers excellent optical transmission and reproducibilitycapabilities, 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 todecrease 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 sampleconcentrations.

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 lamptechnology for fiber optic utilization. Because the system is based on a standardspectrophotometer, parts and service are readily available worldwide.The fiber optic system utilizes a 12-position multiplexer, to read samples sequentially. A singlespectrophotometer can be used with two dissolution apparatus.The fiber optic probes can be mounted on a movable manifold that lowers the probe to thecorrect sampling height in the vessel. The sample is read and the probe is raised either entirelyout of the media or held in the upper level of the media to minimize bubble formation andprevent drying on the tip surface.

Cary 60 UV-Vis Spectrophotometer DimensionsHeight Width Depth Weight19.6 cm / 8 in. 47.7 cm / 19 in. 56.7 cm / 23 in. 18 kg / 40 lb

Cary 60 UV-Vis Spectrophotometer Specifications

Wavelength Range

WavelengthAccuracy

WavelengthReproducibility

PhotometricRange

UV-VislimitingResolution

190 - 1100 nm ± 0.5 at 541.94 nm ± 0.1 nm ± 3.3 Abs ≤ 1.5 nm

Why Choose Fiber Optic UVDissolution?Save time with real-time sampleanalysis and reporting of dissolutiondata using in situ fiber optic probes.Also, no pumps or moving media/samplesmeans no system flush is required. This greatly improves turnaround timeand maximizes efficiency – simply rinseand you're ready to begin the next test.



Progression of a UV Dissolution profile as data is acquired

Cary WinUV Dissolution Software

The Cary WinUV Dissolution Software supports both Agilent’s Multicell and Fiber Optic OnlineUV Dissolution Systems. The software generates accurate and robust data and accommodatesa wide variety of dissolution samples and methods. Analysts can easily customize final reportswith a complete summary of the data acquisition using comparison and statistical evaluationtools, data tables and dissolution profiles.

Agilent Cary 60 UV-Vis SpectrophotometerThe 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 amaximum scan rate of 24,000 nm/min applying a dual-detector approach to measure sampleand source simultaneously.This rugged instrument is easy to operate and economical to own. Because the lamp onlyilluminates when taking a reading, not only do you save energy, but there are significant lampsavings 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

Testing in a RegulatedEnvironment?The Cary WinUV Dissolution Softwareincludes an optional ComplianceManager package that allows yourlaboratory to install and configureproper 21 CFR Part 11 controls.

Did You Know?When the Cary 60 is not being used foran online Dissolution test, there is anentire suite of applications available inthe Cary WinUV software to maximizeits value as a standalone spectrophoto-meter. These include Advanced Reads,Scan, Concentration, Kinetics, andmore.



A comprehensive Method Setup utility is at the core of Cary WinUV Dissolution Software

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

Flexible StandardMeasurement and CalculationOptions

The UV Dissolution applicationincorporates several online standardoptions including Post Cycle Standard(for bracketed analysis), Bridged Mean,and Running Mean. Each methodstores how results are calculateddepending on your specific preferences.

Superior Linear Range (3 Abs)of the Agilent Cary 60 UV-visible Spectrophotometer

The linear range of a spectro-photometer defines the absorbancerange in which measurements areaccurate. The linear range of the Cary 60 permits the analysis of a wide range of sample concentrations,reduces the need for dilution or smallerpath length cells, and measures highlyturbid solutions (for fiber optics).



Agilent’s UV dissolution systems are scalable to your needs. In the ordering tables, you willfind 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 samplingsystems. See page 104 for the dissolution apparatus required for the system.

Dual-cell Tubing KitThe Cary 60 makes it easy tointerconnect two different cells withinthe 16-position multicell transport. This allows you to switch between twosets of cells, typically with differentpath lengths, with no disassembling or reassembling of the tubing lines.Switching between methods requiringcells of different path lengths is as easyas selecting the cells to be read usingthe Cary WinUV Dissolution Software.Only one dissolution apparatus can beused when the dual cell tubing is inplace.

(Continued)

Automated UV Systems – Cary WinUV Dissolution Software andAccessoriesDescription Part NumberCary WinUV Software – UV Dissolution Multicell Packages and SoftwareCary WinUV Software package, for multicell UV dissolution, includes PC, softwareand Cary 60 spectrophotometer with multicell changer

11-1131

Cary WinUV Software package, for multicell UV dissolution, without PC, includessoftware and Cary 60 spectrophotometer with multicell changer

11-1132

Cary WinUV Software, for multicell UV dissolution, version 5 11-1133Cary WinUV Software – UV Dissolution Multicell Accessories / UpgradesBenchtop table for UV dissolution system, with keyboard tray 11-1125Cary 50/60 upgrade kit, includes software, 18-cell holder 11-1142Flow cell for use with Cary 50/60, 10 mm 11-1300Flow cell for use with Cary 50/60, 0.2 mm 11-1301Flow cell for use with Cary 50/60, 0.5 mm 11-1302Flow cell for use with Cary 50/60, 5 mm 11-1305Flow cell for use with Cary 50/60, 2 mm (required for multicell changer upgrade) 11-1310Flow cell for use with Cary 50/60, 1 mm 11-1315Cary 50 extended sample compartment 11-1010Cary 50 tubing coupler 11-1015Cary 50/60 18-cell holder 11-1020Cary 50 PCI card and cable 11-1030Tubing kit, dual path length, for Cary UV Dissolution system 11-1320Tubing replacement kit, for Cary UV Dissolution System, 4 11-1325Tubing replacement kit, for Cary UV Dissolution System, 8 11-1226Cary WinUV Software – UV Dissolution Fiber Optic Packages and SoftwareCary WinUV Software package, for fiber optic UV dissolution, includes PC,software and Cary 60 spectrophotometer with multiplexer

11-1134

Cary WinUV Software package, for fiber optic UV dissolution, without PC, includessoftware and Cary 60 spectrophotometer with multiplexer

11-1135

Cary WinUV Software, for fiber optic dissolution, version 5 11-1136



Upgrade Your Cary 50/60Select the appropriate upgrade option based on the model ofdissolution apparatus to transform your spectrophotometer into an onlineUV dissolution system. The optionsinclude the necessary software, cellchanger or multiplexer, and otheraccessories. Fiber optic probes/tips and flow cells must be orderedseparately depending on the desiredpathlength.

Cary WinUV Software – UV Dissolution Fiber Optic Accessories / UpgradesBenchtop table for UV dissolution system, with keyboard tray 11-1125Fiber optic multiplexer software on CD 11-00604-port USB-to-serial converter 11-1011External cuvette holder, 1 cm, for FO 11-1012External cuvette holder cover, 1 cm 11-1014Fiber optic patchcord, 20 in. 11-1424Fiber optic probe, 2 m, no tip, for 7000, 7010, 708-DS, 709-DS 11-1425Fiber optic probe, 2 m, no tip, 7025/7030 11-1426Fiber optic removable tip, 1 mm 11-1429Fiber optic removable tip, 2 mm 11-1430Fiber optic removable tip, 5 mm 11-1435Fiber optic removable tip, 10 mm 11-1440Fiber optic removable tip, 20 mm 11-1445Fiber optic removable tip, 4 mm 11-1450Fiber optic probe holder, for Distek evaporation cover 12-0592

Cary 50 fiber optic upgrade, includes Cary WinUV software for fiber optic UVdissolution and multiplexer, for 7025

11-1412


11-1413


11-1414

Automated UV Systems – Cary WinUV Dissolution Software andAccessoriesDescription Part Number

Cary 50/60 Upgrade Options

Cary 50 fiber optic upgrade, includes Cary WinUV software for fiber optic UVdissolution and multiplexer, for 708-DS

11-1137


11-1138


11-1139


11-1140

Cary 60 fiber optic upgrade, includes Cary WinUV software for fiber optic UVdissolution and multiplexer, for 708-DS

11-1141



708-DS and Fiber Optic UV Dissolution System Ordering ExampleQuantity Description Part Number1 708-DS system, DDM, sampling, and temperature, 6-position 16-69001 Cary WinUV Software package, for fiber optic UV dissolution,

includes PC, software and Cary 60 spectrophotometer withmultiplexer

11-1134

6 Paddle, lower interchangeable, electropolished stainless steel 12-14216 Fiber optic probe, 2 m, no tip 11-14256 Fiber optic removable tip, 5 mm 11-1435

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.

Cary 60 Fiber Optic UV Dissolution System

Cary 60 integrates easily withsingle- or dual-apparatusoperation for increasedthroughput and automation

• Long-lasting, no warm-up time Xenonlamp flashes only when taking ameasurement

• No degradation of photosensitiveactive drug components associatedwith continually burning lamps

• Virtual immunity to room light,reducing noise and allowing for alinear absorbance range up to 3.3 AU

• Configurable with Agilent 8000 forcollecting and archiving samples forLC analysis (multicell only).



Cary 60 UV Dissolution SystemsTo simplify the selection process with the Cary 60 UV-visible Spectrophotometer, and 708-DS or 709-DS Dissolution Apparatus, refer to the followingordering table. All of these systems include 1L clear glass vessels, a standard 200 mL conversion kit ( (muliticell only), a sampling manifold, tubing andconnectors. 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 Apparatusfor 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

16-62001 and Resident Probe Kit2 16-62001 and Resident Probe Kit2 16-62001 and Resident Probe Kit2

17-2200 (115V) or 17-2300 (230V) 15-5100 (115V) or 15-5110 (230V) 15-5100 (115V) or 15-5110 (230V)

11-11314 (with PC) or 11-11324 (no PC) 11-11314 (with PC) or 11-11324 (no PC) 15-5002 (115V) or 15-5006 (230V)

N/A N/A 11-11314 (with PC) or 11-11324 (no PC)N/A N/A 5075-0449, 5075-0446

708-DS with Autosampling only 16-65001 16-65001 16-65001

17-2200 (115V) or 17-2300 (230V) 15-5100 (115V) or 15-5110 (230V) 15-5100 (115V) or 15-5110 (230V)



708-DS with Autosampling and AutoTemp

16-68001 16-68001 16-68001

17-2200 (115V) or 17-2300 (230V) 15-5100 (115V) or 15-5110 (230V) 15-5100 (115V) or 15-5110 (230V)



708-DS with Autosampling,AutoTemp and DDM

16-71001 16-71001 16-71001

17-2200 (115V) or 17-2300 (230V) 15-5100 (115V) or 15-5110 (230V) 15-5100 (115V) or 15-5110 (230V)



709-DS with Autosampling and AutoTemp

16-75001 16-75001 16-75001

17-2200 (115V) or 17-2300 (230V) 15-5100 (115V) or 15-5110 (230V) 15-5100 (115V) or 15-5110 (230V)



709-DS with Autosampling,AutoTemp and DDM

16-77001 16-77001 16-77001

17-2200 (115V) or 17-2300 (230V) 15-5100 (115V) or 15-5110 (230V) 15-5100 (115V) or 15-5110 (230V)



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 21.3 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 101-102 for ordering information.



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-visibleSpectrophotometer for Fiber Optic UV Analysis

16-62001 and Resident Probe Kit2 16-62001 and Resident Probe Kit2 N/A

15-36303 (115V) or 15-36903 (230V) 15-36503 (115V) or 15-37103 (230V) N/A

11-11314 (with PC) or 11-11324 (no PC) 11-11314 (with PC) or 11-11324 (no PC) N/A

N/A 5075-0449, 5075-0446 N/A

N/A N/A

16-65001 16-65001 16-63001

15-36303 (115V) or 15-36903 (230V) 15-36503 (115V) or 15-37103 (230V)

11-11314 (with PC) or 11-11324 (no PC) 11-11314 (with PC) or 11-11324 (no PC) 11-11344 (with PC) or 11-11354 (no PC)N/A 5075-0449, 5075-0446

N/A N/A

16-68001 16-68001 16-66001

11-11314 (with PC) or 11-11324 (no PC) 15-36503 (115V) or 15-37103 (230V)N/A 11-11314 (with PC) or 11-11324 (no PC) 11-11344 (with PC) or 11-11354 (no PC)N/A 5075-0449, 5075-0446

N/A N/A

16-71001 16-71001 16-69001

15-36303 (115V) or 15-36903 (230V) 15-36503 (115V) or 15-37103 (230V)


N/A N/A

16-75001 16-75001 16-74001

15-36303 (115V) or 15-36903 (230V) 15-36503 (115V) or 15-37103 (230V)


N/A

16-77001 16-77001 16-76001

15-36303 (115V) or 15-36903 (230V) 15-36503 (115V) or 15-37103 (230V)


N/A

Cary 60 with 810 Peristaltic Pump and 8000 DissolutionSampling Station

16-62001 and Resident Probe Kit2

15-3610 (115V) or 15-3670 (230V)

11-11314 (with PC) or 11-11324 (no PC)N/A

N/A

16-65001

15-3610 (115V) or 15-3670 (230V)

11-11314 (with PC) or 11-11324 (no PC)N/A

N/A

16-68001

15-36103 (115V) or 15-36703 (230V)

11-11314 (with PC) or 11-11324 (no PC)N/A

N/A

16-71001

15-36103 (115V) or 15-36703 (230V)

11-11314 (with PC) or 11-11324 (no PC)N/A

N/A

16-75001

15-36103 (115V) or 15-36703 (230V)

11-11314 (with PC) or 11-11324 (no PC)N/A

N/A

16-77001

15-36103 (115V) or 15-36703 (230V)

11-11314 (with PC) or 11-11324 (no PC)N/A

N/A

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Agilent 1290 Infinity LC SystemInfinitely more powerfulThe Agilent 1290 Infinity LC is the last word in chromatographic performance providinghighest speed, resolution and sensitivity.

• Wide power range up to 1200 bar – deploy any particle type, any column dimensions, orany mobile and stationary phases

• For seamless instrument-to-instrument method transfer, simply emulate other LC systemswith Agilent's new ISET – Intelligent System Emulation Technology

• Lower total cost of ownership – get UHPLC productivity at service costs comparable toHPLC equipment quality

Agilent 1260 Infinity LC SystemInfinitely more confidentThe Agilent 1260 Infinity LC raises the standard in HPLC – without raising the price. It offersnew levels of productivity, data quality and robustness to give you highest confidence in yourinvestment.

• 600 bar standard pump pressure, 80 Hz standard detector speed and up to 10 times higherUV detection sensitivity – be prepared for today’s and tomorrow’s challenges

• 100% compatible with all your HPLC methods – ensuring riskless replacement of existingequipment

• 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 thatexactly matches your needs for chromatographic performance and flexibility

Agilent HPLC SolutionsA complete portfolio of scalable HPLC and UHPLCsolutions for dissolution analysis. For utmost flexibility Agilent has created a continuum of products – from compact instrumentsfor routine LC to ultrahigh performance LC/MS systems. Choose the best configuration tooptimize every part of your laboratory operations and be assured that each system can beenhanced as required to meet future challenges.

Regardless of your workflow, we have a solution to your method. We offer offline analysisthrough a segmented collection and filtration (down to 0.45 µm), as well as online analysiswith the collection and filtration followed by direct injection. Additionally, our systems providearchival of samples in the event a failure investigation is required.

Automated HPLC Systems

www.agilent.com/lifesciences/HPLCdissolution

Agilent 1260 Infinity LC System


107

Agilent 1220 Infinity LC System Infinitely more affordable

• 600 bar power range up to 5 mL/min and 80 Hz detector speed – prepare your lab to takeadvantage of latest advances in LC column technology

• Full compatibility with all other detectors within the 1200 Infinity Series and with 6100Series Quadrupole MS – run any existing HPLC or UHPLC method

• Uses same technology and parts as 1260 and 1290 Infinity LC systems

Integrating Dissolution Apparatus with Other AnalyticalInstrumentsOf course our first priority is integrating Agilent dissolution apparatus with Agilent analyticalinstruments and software. Having one source of dissolution equipment, analyticalinstrumentation and software ensures you receive the best service and support. We alsorealize that there are many other brands of equipment, so Agilent offers solutions to give youthe 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 dissolutionapparatus.

If you are interested in integrating an existing HPLC system to an Agilent dissolutionapparatus, 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 injectionsare made between timepoints.

The Agilent 1220 Infinity LC is a high quality, integrated system for routine HPLC andadvanced UHPLC analysis, for maximum return on investment.

Agilent 8020 Dissolution Sampling/HPLC Injector

Automated HPLC Systems

www.agilent.com/lifesciences/HPLCdissolution


For more information on the integration of Agilent dissolution equipment with other analyticalinstruments, contact your Agilent representative.

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Physical Testers

www.agilent.com/lifesciences/physicaltesters

Agilent 100 Automated DisintegrationApparatus and AccessoriesIntegrated disintegration testing that conforms toharmonized regulatory requirements

• 6-tube basket(s), 10-mesh / 1905 µm (USP) • Fluted disks – USP• Disintegration beaker(s) – USP • Disintegration spacer gauge – 25 mm

An integral prerequisite for dissolution, dosage forms must be tested for disintegration toensure maximum active pharmaceutical ingredient (API) contact with media and subsequentbioavailability. The disintegration test is an important quality control process that helps ensurethe 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, andheater/circulator are incorporated into a single instrument offering a compact design to savevaluable bench space. The apparatus is available in single- or three-basket models and comescomplete 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 berun simultaneously or sequentially, maximizing laboratory efficiency. The optional printer canbe added to document critical test information.

The standard 100 Automated Disintegration Apparatus comes with:

Agilent 100 Automated Disintegration Apparatus, 3-basket model

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Physical Testers


100 Automated Disintegration Apparatus BasketsDescription Part NumberBasket, 6-tube, 10-mesh, 1905 µm (USP) 37-3001Basket, 6-tube, 10-mesh, 1905 µm (USP), verified with certificate 37-3001VBasket, 6-tube, 20-mesh, 864 µm 37-3010Basket, 6-tube, 10-mesh, 1905 µm, Nylon, stainless steel screen 37-3020Basket, 3-tube, 10-mesh, 1905 µm, 38 mm outer dia., 37-3030Basket, 3-tube, 10-mesh, 1905 µm, 38 mm outer dia., verified with certificate 37-3030VBasket, 1-tube, 10-mesh, 1905 µm, 44 mm outer dia. 37-3040Basket, 6-tube, 40-mesh, 381 µm, with screened cover 37-3050

Standard Disintegration Apparatus BasketsDescription Part NumberBasket, 6-tube, 10-mesh, 1905 µm, USP 37-2001Basket, 6-tube, 10-mesh, 1905 µm, USP, verified with certificate 37-2001VBasket, 6-tube, 20-mesh, 864 µm 37-2010Basket, 6-tube, 10-mesh, 1905 µm, Nylon, stainless steel screen 37-2020Basket, 6-tube, 10-mesh, 1905 µm, Plexiglass, stainless steel screen 37-2025Basket, 3-tube, 10-mesh, 1905 µm, 38 mm outer dia. 37-2030Basket, 1-tube, 10-mesh, 1905 µm, 44 mm outer dia. 37-2040Basket, 6-tube, 40-mesh, 381 µm, with screened cover 37-2050Basket, suppository dosages 37-2060

100 Automated Disintegration ApparatusDescription Part Number100 Automated Disintegration Apparatus, single basket, 115V (USP) 35-4000100 Automated Disintegration Apparatus, single basket, 230V (USP) 35-4100100 Automated Disintegration Apparatus, three-basket, 115V (USP) 35-4200100 Automated Disintegration Apparatus, three-basket, 230V (USP) 35-4300

Verified DisintegrationAccessories

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

Many standard disintegrationaccessories, such as the basket rackassemblies, can be ordered withindividual certificates that verifyconformance of critical dimensions. Thecertificates include the measurements,measuring device information, and itstraceability. Any part number that endsin “V” indicates a Verified component.

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Physical Testers


1L disintegration beaker

100 Automated and Standard Disintegration Apparatus AccessoriesDescription Part NumberSuspension rod dia. for holding 1-basket rack 37-1040Cover, for 6-tube, 10-mesh, 1905 µm basket 37-2100Cover, for 3-tube, 10-mesh, 1905 µm basket 37-2105Cover, for 6-tube, 40-mesh, 381 µm basket 37-2110Screen, 10-mesh, 1905 µm, stainless steel, for 6-tube basket, set of 6 37-2200Screen, 20-mesh, 864 µm, stainless steel, for 6-tube basket, set of 6 37-2205Screen, 40-mesh, 381 µm, stainless steel, for 6-tube basket, set of 6 37-22106 USP fluted disks, for Agilent 100 and Standard Disintegration Apparatus 37-40006 USP fluted disks, for Agilent 100 and Standard Disintegration Apparatus,verified with certificate

37-4000V

3 Plastic disks, for Agilent 100 and Standard Disintegration Apparatus 37-40101 Plastic disk, for Agilent 100 and Standard Disintegration Apparatus 37-40206-tube plunger assembly 37-41003-tube plunger assembly 37-41106-tube plunger assembly, for use in Canada 37-4120Replacement tubes, 6-tube basket, 25 mm, set of 6 37-5000Replacement tubes, 6-tube basket, 25 mm, set of 6, verified with certificate 37-5000VReplacement tubes, 3-tube basket, 38 mm, set of 3 37-5005Replacement tube, 1-tube basket, 44 mm 37-5010Disintegration beaker, for Standard Disintegration Apparatus 37-5200Disintegration beaker, USP 9th supplement, for Agilent 100 and StandardDisintegration Apparatus

37-5305

Disintegration beaker, USP 9th supplement, for Agilent 100 and StandardDisintegration Apparatus, verified with certificate

37-5305V

Water bath, molded with frame, for 6-basket system, Standard DisintegrationApparatus

37-6000

Water bath, molded with frame, for 1- and 3-basket systems, StandardDisintegration Apparatus

37-6010

Disintegration gauge, 2.5 cm, from vessel bottom 37-9000Water bath temperature probe 67-0300

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Physical Testers


100 Automated Disintegration Printer OptionsDescription Part NumberRetrofit printer option, for Agilent 100, pre-CE marking, 115V 37-0150Retrofit printer option, for Agilent 100, pre-CE marking, 230V 37-0155Printer option (or retrofit), for Agilent 100, CE marking, 115/230V 37-0200

100 Automated Disintegration Apparatus DimensionsHeight Width Depth Weight74.93 cm / 29.5 in. 55.88 cm / 22 in. 52.07 cm / 20.5 in. 29.7 kg / 65.5 lbs,

dry with 3 baskets

100 Automated Disintegration Apparatus SpecificationsDip Speed (DPM)

Stroke Length(cm)

TemperatureRange (°C)

TemperatureAccuracy (°C)

Test Duration(hh:mm:ss)

30 ± 1 5.5 ± 0.1 Ambient + 5 to 55

± 0.2 Each position isprogrammable up to 99:59:59

By outfitting the 100 AutomatedDisintegration Apparatus with theoptional printer, you have the ability to record instrument status at apredefined interval as well as at anytime during the test by pressing Print on the instrument panel.

Instant Status Reporting

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Physical Testers


Agilent 200 Tablet Hardness Tester andAccessoriesCompact, rugged instrument for precise hardnesstesting on a variety of tablet shapes and sizesThe 200 Tablet Hardness Tester provides accurate testing of tablet hardness in a small-footprint 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 50kiloponds (kp) using a variety of jaw plates that adapt to almost any size or shape tablet.Tablet thickness and diameter can also be measured using the optional digital gauge. Results are documented, complete with a statistical summary, by using the optionalstandalone printer. The calibration of the 200 Tablet Hardness Tester is a straightforwardprocedure that can be completed within minutes using a series of slotted weights andadjustment 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

Agilent 200 Tablet Hardness Tester

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Physical Testers


200 Tablet Hardness Tester Calibration ToolsDescription Part NumberCalibration fixture 42-2000Trim pot tool 42-2005Hardness/calibration weight hanger 42-2020Calibration weight, 200 gm, with certificate 42-1200Calibration weight, 500 gm, with certificate 42-1205Calibration weight, 1kg, with certificate 42-1210Calibration weight, 2 kg, with certificate 42-1215Calibration weight, 5 kg, with certificate 42-1220Calibration weight, 10 kg, with certificate 42-1225Calibration weight, 20 kg, with certificate 42-1230

200 Tablet Hardness TesterDescription Part Number200 Tablet Hardness Tester, 115V, kp/SC 40-2000200 Tablet Hardness Tester, 115V, kp/N 40-2010200 Tablet Hardness Tester, 115V, SC/N 40-2011200 Tablet Hardness Tester, 115V, kp/SC, with thickness/diameter gauge 40-2012200 Tablet Hardness Tester, 230V, kp/SC 40-2100200 Tablet Hardness Tester, 230V, kp/N 40-2110200 Tablet Hardness Tester, 230V, SC/N 40-2111200 Tablet Hardness Tester, 230V, kp/SC, with thickness/diameter gauge 40-2112200 Tablet Hardness Tester, 115V, kp/SC, 50 kp 40-2200200 Tablet Hardness Tester, 230V, kp/SC, 50 kp 40-2300

A. Calibration weight hangerB. Slotted calibration weightC. Tablet trayD. Tablet fragment shieldE. Trim pot tool

A

B

C

D

EF

Periodically Verify Performancewith EaseEnsure your 200 Tablet Hardness Testeris performing as expected. Using thecalibration weight hanger andadjustment tools with a slottedcalibration weight, you can easilycalibrate your instrument withinminutes.

F. Tablet fragment brush

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Physical Testers


200 Tablet Hardness Tester Jaw PlatesDescription Part NumberJaw plate, standard 42-1000Jaw plate, shelf type 42-1005Jaw plate, 1/8 x 60 degree 42-1010Jaw plate, 1/16 radius 42-1015Jaw plate, 1/4 radius 42-1020Jaw plate, 1/8 radius 42-1025Jaw plate, bolus type 42-1030Jaw plate, 3/16 radius 42-1035Jaw plate, flat face 42-1040Jaw plate, adjustable 42-1050

200 Tablet Hardness Tester and AccessoriesDescription Part NumberHardness/fragment safety shield 42-2010Hardness/fragment brush 42-2030Tablet thickness gauge, handheld, dial gauge, 0-10 mm 42-6105Tablet thickness gauge, handheld, digital gauge, 0-10 mm 42-6110RS232 serial port, retrofit 42-0250Thickness gauge option 42-0300Thickness gauge retrofit option 42-0350Battery for Mitutoyo gauge 42-0355

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

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Physical Testers


200 Tablet Hardness Tester Printer OptionsDescription Part NumberPrinter, 115V/230V 42-0120Printer, retrofit, 115V/230V 42-0160Printer, 50 kp, retrofit, 115V/230V 42-0162Printer, kp/N, retrofit, 115V/230V 42-0164Printer, SC/N, retrofit, 115V/230V 42-0166

200 Tablet Hardness Tester DimensionsHeight (withthickness gauge)

Height (withoutthickness gauge) Depth Width Weight

28 cm / 11 in. 28 cm / 11 in. 17.8 cm / 7.0 in. 27.9 cm/ 11 in. 6.1 kg / 13.5 lbs

Force Conversion Chart1 kilopond = 9.807 Newton 1 pound = 0.45359 kilopond 1 kilopond = 2.2046 pound 1 StrongCobb = 0.714 kilopond

Automate Documentation andStatistical Analysis of ResultsThe inclusion of the optional compliant printer allows for hardcopydocumentation of all testing results. The printout includes a time/datestamp, individual tablet results, and astatistical breakdown that consists of:total number of tablets tested, high,low, range, mean, standard deviation,and % relative standard deviation.

200 Tablet Hardness Tester Specifications

Range

Thickness(with optionalthickness gauge)

MinimumTablet Diameter

MaximumTablet Diameter Accuracy

0.4 to 35 kiloponds(up to 50 kpavailable)

Resolution of 0.01 mm / 0.001 in.

0.3175 cm / 0.125 in. with shelf type jaw plate

3.4925 cm / 1.375 in.

0.3175 cm /0.125 in. with shelf typejaw plate

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Physical Testers


Agilent 250 Friability Tester and AccessoriesEfficiently replicate environmental factors forcompressed tabletsThe Agilent 250 Friability Tester simulates the rigorous environment that compressed tabletswithstand during manufacturing, packaging and distribution. Tablets are placed into a drumand 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 dual-drum configurations. The unit can be preprogrammed for a specific time period for testing orfor a set number of rotations. The initial tablet weight can be stored to easily calculate theactual percent weight loss. As the 250 Friability Tester runs, elapsed time and revolutioncounts will display depending on the chosen method.

• Test two batches using the single-chamber, dual-drum model, or up to four different batchessimultaneously with the dual-chamber, dual-drum model for greater productivity.

• Rugged, durable and compact design endures continuous daily usage and easily fits intosmall laboratory or production areas.

• Three drum options include the single-chamber drum, the dual-chamber drum and theabrasion drum.

• For increased accuracy, verified single- and dual-chamber drums are available. VerifiedAccessories are individually measured for conformance and include a certificate with actualmeasured 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 irregulartumbling or binding.

Note: Initial and final weights should be measured using an analytical balance.

Agilent 250 Friability Tester with one dual-chamber drum

Standard 250 Friability Testers include either one or two clockwise-rotating drums, dependingon your configuration. The abrasion drum, which rotates both clockwise and counterclockwise,as well as single- and dual-chamber counterclockwise-rotating drums are available. Anoptional printer can be factory-installed or retrofitted at a later date.

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Physical Testers


250 Friability Tester Printer OptionsDescription Part NumberPrinter, 115V/230V 47-0120Printer, 115V/230V, retrofit 47-0153

250 Friability TestersDescription Part Number250 Friability Tester, 1 dual-chamber drum, 115V 45-1000250 Friability Tester, 1 single-chamber drum, 115V 45-1200250 Friability Tester, 1 dual-chamber drum, 230V 45-1300250 Friability Tester, 1 single-chamber drum, 230V 45-1400250 Friability Tester, 2 dual-chamber drums, 115V 45-2000250 Friability Tester, 2 single-chamber drums, 115V 45-2100250 Friability Tester, 2 dual-chamber drums, 230V 45-2200250 Friability Tester, 2 single-chamber drums, 230V 45-2300250 Friability Tester, 2 single-chamber drums, 230V/60Hz 45-2350

Agilent 250 Friability Tester, single-drum configuration

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Physical Testers


(Top to bottom) Single-chamber drum, Dual-chamber drum, and Abrasion drum

10-degree lift (wedge)

250 Friability Tester AccessoriesDescription Part NumberDual-chamber drum, clockwise rotation 47-1000Dual-chamber drum, clockwise rotation, with certificate 47-1000VDual-chamber drum, counterclockwise rotation 47-1005Dual-chamber drum, counterclockwise rotation, with certificate 47-1005VSingle-chamber drum, clockwise rotation 47-1010Single-chamber drum, clockwise rotation, with certificate 47-1010VSingle-chamber drum, counterclockwise rotation 47-1015Single-chamber drum, counterclockwise rotation, with certificate 47-1015VAbrasion drum 47-102010-degree lift (wedge) 47-1030Printer, 115V/230V 47-0153

250 Friability Tester DimensionsHeight with drums

Width withsingle drum

Width with dual drums

Depth withdrums

Weight withdual drums

34.93 cm / 13.75 in.

32.38 cm / 12.75 in.

40.94 cm / 16.12 in.

31.11 cm / 12.25 in.

9.9 kg / 21.9 lbs.

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Physical Testers


Agilent 350 Tapped Density Tester andAccessories

Through a standardized and repeatable procedure, the 350 Tapped Density Tester measuresthe tapped or packed volumes of powders, granulated and flaked materials. The tester’sunique tapping and rotary action packs material evenly to create a level surface for directreading of measurements within the graduated cylinder. The tester is available in either a single- or dual-platform and the dual version allows fortesting to start and stop at the same time. Platforms conform to either USP specifications or ASTM standards for tapped density testing.

• Single- or dual-platform configurations available in either USP Method I, USP Method II orASTM versions.

• Choice of 10, 100 or 250 mL graduated cylinders with a funnel top. Graduated cylinderswith 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 specificsize cylinders.

• An optional printer can be factory-installed or retrofitted at a later date.

Reduce the Noise

350 Tapped Density Tester, dual-platform with 100 mLgraduated cylinder

The optional acoustic cabinet helpswith sound control by reducing thenoise level from an operating testerwhile providing visibility of theinstrument through the front Plexiglassdoor. See page 121 for orderinginformation.

Locking cylinder platforms ensure the glass cylinders are held firmly in place. The tester allowsfor a 14 ± 2.0 mm drop height for the USP Method I version, and a 3 ± 0.2 mm drop heightfor the USP Methods I and II and ASTM versions. Depending upon the type of testercompliance, speeds of 300 taps per minute for the 14 mm drop and 250 taps per minute forthe 3 mm drop, are maintained.

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Physical Testers


350 Tapped Density Tester Optional PrintersDescription Part NumberPrinter, 115V/230V 52-0120Printer, retrofit, 115V/230V 52-0153

350 Tapped Density Tester, single-platform with 100 mLgraduated cylinder

350 Tapped Density TesterDescription Part Number Part NumberUSP Method I, 14 mm drop Single-platform Dual-platform350 Tapped Density Tester, 115V, 100 mL 50-1000 50-1200350 Tapped Density Tester, 230V, 100 mL 50-1100 50-1300350 Tapped Density Tester, 115V, 250 mL 50-1810 50-1850350 Tapped Density Tester, 230V, 250 mL 50-1800 50-1851USP I and II and ASTM Methods, 3 mm drop Single-platform Dual-platform350 Tapped Density Tester, 115V, 250 mL 50-2000 50-2200350 Tapped Density Tester, 230V, 250 mL 50-2100 50-2300350 Tapped Density Tester, 115V, 100 mL 50-3000 50-3200350 Tapped Density Tester, 230V, 100 mL 50-3100 50-3300

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Physical Testers


100 and 250 mL graduated cylinders

Acoustic cabinet

350 Tapped Density Tester Dimensions Height (14 mm drop with platform) Width Depth 26.7 cm / 10.5 in. 30.5 cm / 12 in. 28.1 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 / 22.25 in.Weight (dual platform without cylinders) 12.3 kg / 27 lbs.

350 Tapped Density Tester AccessoriesDescription Part NumberTapped Density Tester PlatformsPlatform, 10 mL, 14 mm drop, USP 52-1000Platform, 25 and 50 mL, 14 mm drop, USP 52-1010Platform, 100 mL, 14 mm drop, USP 52-1020Platform, 250 mL, 14 mm drop, USP 52-1030Platform, 500 mL, 14 mm drop, USP 52-1040Platform, 10 mL, 3 mm drop, USP or ASTM 52-1050Platform, 25 and 50 mL, 3 mm drop, USP or ASTM 52-1060Platform, 100 mL, 3 mm drop, USP or ASTM 52-1070Platform, 250 mL, 3 mm drop, USP or ASTM 52-1080Graduated CylindersGraduated cylinder, funnel top, hexagonal base, 10 mL 52-5000Graduated cylinder, funnel top, hexagonal base, 100 mL 52-5010Graduated cylinder, funnel top, hexagonal base, 250 mL 52-5020Graduated cylinder, standard top, hexagonal base, 25 mL 52-5040Graduated cylinder, standard top, hexagonal base, 50 mL 52-5050Graduated cylinder, standard top, hexagonal base, 500 mL 52-5060Acoustic CabinetAcoustic cabinet 52-2010Note: Select the correct platform and cylinder combination to ensure the cylinder is properly held in place.

122

Service and Qualification

www.agilent.com/lifesciences/dissolutionservices

Service and QualificationAgilent Services and Support: Your Laboratory Partner

Agilent offers you a variety of comprehensive qualification and service options for yourdissolution apparatus and analytical instruments. Focus on what you do best and let Agilentprovide you with installation and familiarization, hardware and software training, andcomplete qualification services.Our service organization has the experience, education and training to ensure your dissolutionequipment is properly installed and qualified, not only at the time of purchase, but throughoutthe life of the instrument. Our engineers and chemists are cGMP-trained and receive extensiveongoing 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 yourequipment uptime, adhering to agreed-upon service and qualification schedules, minimizingyour compliance risk and reducing your administrative burdens.

Preventative Maintenance and Repair ServiceKeeping your dissolution apparatus in top condition is critical to meeting current USPPerformance Verification Test (PVT) requirements, as well as the recent enhanced MechanicalQualification (MQ) specifications put forth by the FDA and ASTM. It is even more importantthat your apparatus are routinely serviced. We offer a number of repair contract options thatcover maintenance, repair and qualification services. For Agilent's Service Center Repairinformation, visit www.agilent.com/lifesciences/dissolutionrepair

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Qualification DocumentationMaintaining the proper instrument and qualification documentation is essential. To ensure youmeet the cGMP requirements, Agilent provides qualification guides for all our dissolution andphysical testing instrumentation. Our qualification guides include installation qualification (IQ),operational qualification (OQ), and in the case of Apparatus 1, 2 and 3, a performancequalification (PQ) based on the USP Performance Verification Test (PVT). A mechanicalqualification (MQ) guide is also available. Our PQ guide contains current USP practices forqualification with current acceptance criteria. Similarly, the MQ guide accurately reflects thecurrent specifications and tolerances for physical parameters contained in the ASTM and FDAprocedures. These guides are included with service purchases or can be ordered separately.Our dedicated compliance group strives to ensure this documentation remains currentaccording to the ever-changing industry regulations.

Compliance ServicesOur laboratory services group provides a cost-effective alternative to performing thesequalification 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 ourown equipment, as well as for all other brands of dissolution apparatus. We will work withyou or your metrology department to establish a schedule to ensure your equipment remainsqualified. When performing a PQ for Apparatus 1 and 2, our services include a verification ofthe critical physical parameters and the chemical qualification using your USP prednisonetablets 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 relevantphysical parameters. Our guides include the specifications as outlined in the USP, as well asthe FDA and ASTM recommendations.

Training and Educational ServicesAgilent offers training on the proper operation of all its equipment. This service can be orderedat the time of instrument purchase. We also offer a variety of other educational programs thatare 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 yourspecific needs.

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708-DS and 709-DS Dissolution ApparatusIQ Service SYS-DI-708 2N9 76-3037OQ Service SYS-DI-708 2B9 76-3038PQ Service SYS-DI-708 2P9 70-6960MQ Service SYS-DI-708 2M9 76-30427000/7010 Dissolution ApparatusIQ Service SYS-DI-7010 2N9 76-2000OQ Service SYS-DI-7010 2B9 76-2001PQ Service SYS-DI-7010 2P9 70-6960MQ Service SYS-DI-7010 2M9 76-30427025 Dissolution ApparatusIQ Service SYS-DI-7025 2N9 76-2100OQ Service SYS-DI-7025 2B9 76-2101PQ Service SYS-DI-7025 2P9 70-6960MQ Service SYS-DI-7025 2M9 76-30427030 Dissolution ApparatusIQ Service SYS-DI-7030 2N9 76-2200OQ Service SYS-DI-7030 2B9 76-2201PQ Service SYS-DI-7030 2P9 70-6960MQ Service SYS-DI-7030 2M9 76-3042705-DS Dissolution ApparatusIQ Service SYS-DI-705 2N9 76-3010OQ Service SYS-DI-705 2B9 76-3011PQ Service SYS-DI-705 2P9 70-6960MQ Service SYS-DI-705 2M9 76-3042

Compliance Services

Description Service Part NumberQualification Guide Part Number*

(Continued)

*Qualification guides are included as part of AIQ services and do not need to be orderedseparately.

Did You Know?A wide variety of preventivemaintenance and service agreementsare available for all of Agilent'sdissolution and physical testinginstruments. Contact your local Agilent representative to find the solution that best fits yourlaboratory's needs.

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(Continued)


BIO-DIS Reciprocating Cylinder ApparatusIQ Service SYS-DI-BIO 2N9 76-3052OQ Service SYS-DI-BIO 2B9 76-3053PQ Service SYS-DI-BIO 2P9 76-3054Reciprocating Holder Apparatus 7IQ Service SYS-DI-APP7 2N9 76-3052OQ Service SYS-DI-APP7 2B9 76-3053400-DS Apparatus 7IQ Service SYS-DI-400 2N9 76-3061OQ Service SYS-DI-400 2B9 76-3062Rotating Bottle ApparatusIQ Service SYS-DI-RBOT 2N9 76-3058OQ Service SYS-DI-RBOT 2B9 76-30598000 Dissolution Sampling StationIQ Service Add "-E" to SYS-DI-XXX 2N9 76-3043OQ Service Add "-E" to SYS-DI-XXX 2B9 76-30448020 Dissolution Sampling/HPLC InjectorIQ Service Add "-E" to SYS-DI-XXX 2N9 76-3046OQ Service Add "-E" to SYS-DI-XXX 2N9 76-3047Dissolution Workstation Software IQ Service Add "-E" to SYS-DI-XXX 2N9 70-6953OQ Service Add "-E" to SYS-DI-XXX 2B9 70-6955


Compliance Services

Compliance Services Ordering ExampleQuantity Description Part Number1 708-DS, 8000 IQ Service (includes documentation) SYS-DI-708-E 2N91 708-DS, 8000 OQ Service (includes documentation) SYS-DI-708-E 2B91 708-DS PQ Service (includes documentation) SYS-DI-708 2P9

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Cary 60 Multicell UV Dissolution System and Cary WinUV Software (software version 4.0 and higher)IQ Service SYS-UV-50 2N9 76-3018OQ Service SYS-UV-50 2B9 76-3019Cary 50/60 calibration service SYS-UV-50 2V9 76-3024Cary 60 Fiber Optic UV Dissolution System and Cary WinUV Software (software version 4.0 and higher)IQ Service SYS-UV-50 2N9 76-3022OQ Service SYS-UV-50 2B9 76-3023Cary 50/60 calibration service SYS-UV-50 2V9 76-3024UV Dissolution System and Cary WinUV Software (software pre-version 4.0)IQ/OQ for UV Multicell DissolutionSoftware (version 2.5)

SYS-UV-50 2N9 70-4920

IQ/OQ for UV Fiber OpticDissolution Software (version 2.1)

SYS-UV-50 2B9 70-4935

8453 UV Dissolution SystemIQ Service (Base system) SYS-UV-VIS R22N091 IncludedOQ/PQ Service (Base system) SYS-UV-VIS R22B091

Note: Add R22K091 per optional accessory

Included

IQ Service (System) SYS-UV-VIS-E R22N091 IncludedOQ/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 IncludedIQ Service (One additional software module)

R1009A #001 Included

IQ Service (Security pack) R1009A #002 IncludedOQ/PV Service (General purpose) R1010A IncludedOQ/PV Service (Security pack forone additional software module)


OQ/PV Service (One workstation) R1010A #002 IncludedOQ/PV Service (Security pack forserver share tests)



Compliance Services

(Continued)


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100 Automated Disintegration ApparatusIQ Service SYS-DI-PHYS 2N9 76-3067OQ Service SYS-DI-PHYS 2B9 76-3068200 Tablet Hardness TesterIQ Service SYS-DI-PHYS 2N9 76-3070OQ Service SYS-DI-PHYS 2B9 76-3071

IQ Service SYS-DI-PHYS 2N9 76-3073250 Friability Tester

OQ Service SYS-DI-PHYS 2B9 76-3074350 Tapped Density TesterIQ Service SYS-DI-905 2N9 76-3076OQ Service SYS-DI-905 2B9 76-3077


Compliance Services

128 www.agilent.com/lifesciences/dissolutioneducation

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 withdissolution testing. Our instructors include Agilent employees, as well as prominent scientistsfrom 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 latestregulations and what it takes to comply.These courses are offered at our Cary, NC training facility on a yearly schedule, or taught on-site, anywhere around the world. For a complete list of seminar dates and locations, pleasecheck our web site at www.agilent.com.

Fundamentals of DissolutionThis comprehensive two-day course is designed for new and emerging dissolution analysts.The course places emphasis on basic dissolution fundamentals and theory, along with focuseddiscussions on current compendial dissolution testing apparatus, USP physical parameterrequirements and the current USP calibration procedure. Hands-on workshops provideparticipants with experience preparing for and executing a dissolution test. This course willbenefit novice, as well as experienced, dissolution analysts and those in quality control andassurance, calibration, and metrology. This course also serves as a refresher for thoseindividuals with limited or intermediate dissolution experience. The hands-on workshopsinclude dissolution apparatus familiarization, performing the dissolution test, and physicalsuitability 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

Educational Services and Industry Support

129


www.agilent.com/lifesciences/dissolutioneducation

Dissolution Method Development and ValidationDesigned for experienced R&D, method development, or QC chemists interested in thedevelopment and validation of discriminating in vitro dissolution methods, this highly intensivetwo-day course offers an interactive approach to the selection of a discriminating method,including discussion of biorelevant media and test conditions and an examination ofappropriate testing equipment. New advancements in noncompendial apparatus andautomated equipment (including fiber optics) in regards to innovative method developmentare also explored. The Biopharmaceutics Classification System will be an integral part of themethod development aspects.

Accompanying these topics are presentations of regulatory guidelines for concise methodvalidation and instructional exercises designed to enhance the student’s learning experience.Participants will be encouraged to share their method development experiences andproblems. This course is designed for individuals involved with research and development,quality control/quality assurance, and pharmacokinetics.

Topics:

Upon successful completion of this course the attendee should be able to:

• 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

• 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

130

Correlating Dissolution and Bioavailability:Understanding IVIVCThis two-day course is designed for advanced dissolution analysts and individuals involvedwith analytical method development and validation, as well as quality control/assurance,formulations, stability, pharmacology, pharmacokinetics and regulatory affairs. In vitrodissolution tests seem to be the most reliable predictors of in vitro availability. While thebioavailability of drug substances and drug products in humans can provide evidence of apotential relationship between dissolution and physiological availability, it is often impracticalto perform extensive and expensive human testing. The goal of the course is to learn how toassess 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

• 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



131

In Vitro Dissolution of Ointments, Creams, andTransdermalsDesigned for academic researchers and industry scientists with interests in evaluating drugrelease from topical preparations, the goal of the two-day course is for the participant to learnthe application of current dissolution testing techniques and equipment in the evaluation ofdrug release from semisolids and transdermal drug delivery systems (both immediate andcontrolled 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:

The hands-on workshop includes:


• 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

• Use of the Enhancer Cell and Franz Cell• Data analysis• Method development• Demonstration of Apparatus 5, 6, and 7

• 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



132



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 demonstratebioavailability and bioequivalence of pharmaceutical formulations without designing andexecuting time consuming and expensive clinical trials in humans. Two pharmaceuticalformulations are considered bioequilivent (BE) when their respective rate and extent ofbioavailability (BA) following administration of a unit dose under standard clinical experimentalconditions are substantially similar. In vitro testing is an ideal surrogate for predicting BA or BEof pharmaceutical formulations. This course presents the fundamental considerations necessaryto 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• f1 and f2 equations• IVIVC relevant to generics• Computation of PK parameters for BA/BE• Worldwide regulatory requirements for demonstration of BE, design of a clinical protocol

• Understand BCS and dissolution testing• Develop dissolution test method development for generic formulations• Use f1 and f2 expressions in generic drug development• Comprehend IVIVC relevant to generic pharmaceuticals• Compute PK parameters for BA and BE• Design basic clinical protocol

Dissolution and Bioequivalence of Generic Pharmaceuticals

For more information on dissolution seminars, visitwww.agilent.com/lifesciences/dissolutioncoursesFor more information regarding on-site courses, contact your local Agilent representative.

Dissolution Seminar Series

133



Self-paced Learning

Adapted from the highly successful Agilent Fundamentals of Dissolution seminar, thecomprehensive 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 canbe accomplished on-site in a standardized format that ensures consistency for your entireorganization. Mastery of the material is assured via a comprehensive exam completed onlineafter studying the CD. Test results are communicated back to the student and the designatedadministrator.

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 similarlytrained. Document that your scientists and technicians are following the majorpharmacopoeias with this CD today!

Agilent offers the Dissolution 1-on-1 self-paced learning curriculum where you can completethe 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 classroomsetting. This interactive course is designed for the individual so scientists and technicians canlearn at their own pace.

Dissolution 1-on-1 CDDescription Part NumberDissolution 1-on-1 CDInitial CD for 10-user license, 1 year

70-7110

Dissolution 1-on-1 CDSecond CD for additional 10-user license, 1 year

70-7111

Dissolution 1-on-1

This CD-based dissolution trainingprogram is organized into four mainsections with reference material.

• An introduction with information on what happens when medicineenters the body and an overview ofdissolution testing, instruments anddata collection.

• Section 2 includes specifics fordissolution Apparatus 1 and 2,compendial information, criticalphysical parameters, calculation and analysis.

• Section 3 discusses calibration ofApparatus 1 and 2, physical andchemical calibrations and failureinvestigations.

• The supplemental section includesinformation on automated testing,sampling, analysis, data reduction,clean up and changeover.

• Reference materials includeregulatory information, observations,SOPs and helpful resources.

Syllabus for DissolutionTraining

134



Video TrainingLabcast: Live from the Agilent Global Broadcast Studio

What is Labcast?In simple terms, Labcast is a way for Agilent to communicate through video conferencingequipment with other capable sites around the world. Video broadcasting from our studios inCary, NC allows instantaneous conferencing, training and services to all points around theglobe. Agilent trainers can televisit you and your employees to explore the latest methods andtechniques for effective dissolution testing. Keep your lab personnel updated on new practiceswith ongoing education programs and even link with other locations for standardized trainingsessions. All this without leaving home. Contact us to learn more!

Dissolution Apparatus Qualification; PVT versus MQ,What is Right For Your Laboratory60-minute moduleAgilent’s Laboratory Services has prepared a one-hour seminar on the qualification of USPApparatus 1 and 2. Significant changes have occurred in dissolution apparatus qualificationduring the last several years. The USP Performance Verification Test (PVT) migrated from arange test to a much more definitive test which focuses greatly on accuracy and variability ofthe dissolution apparatus through new acceptance criteria highlighting the geometric meanand %CV. Likewise, the alternative approach towards apparatus qualification, enhancedMechanical 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

135



Dissolution Aberrant Data Investigation60-minute moduleLack of proper failure investigation and documentation generally leads the list of problems inFDA observations of analytical laboratories. Many standard operating procedures for handlingout-of-specification data do not properly deal with dissolution data. Join our chemists for alive seminar on the proper procedures for investigating and documenting out-of-specificationdissolution test results in your lab.


• 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 360-minute moduleThe reciprocating cylinder, or Apparatus 3, became an official method in the USP XXII, Fifth Supplement. Given the increasing introduction of modified and extended releaseproducts, this valuable tool is growing in usage. This one-hour presentation covers thehistorical development as well as the principles of the operation and is designed for anyoneinterested in learning how the instrument operates.


• 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

136



www.dissolution.com

Dissolution Discussion GroupTap into the knowledge-base from dissolution usersaround the world!The Agilent-sponsored DDG is a vendor-neutral online forum designed to host discussions onindustry research, best practices, regulatory issues, R&D challenges and more, all in an openenvironment that is free from regulatory oversight. Discussions are anonymous and supportedby fellow analysts and chemists in QC, R&D, stability and academia.

Immediate Release NewsDDG members receive a free, bimonthly e-mail copy if Immediate Release News,your source for linking to the latestdissolution-related information, helping you navigate the constantly changingpharmaceutical environment. Simply join the DDG on www.dissolution.com toreceive your copy!

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You can have this dissolution-specific newsletter delivered right to your inbox! With the lateston our dissolution products, services and the ever-evolving regulatory environment, PracticalSolutions is your resource to stay informed.

To receive your copy, register at www.agilent.com/lifesciences/dissolution_registration.

Agilent's dissolution chemists are always available to assist with questions about finding theinstrument that best supports your laboratory, method development and regulatory support.Contact our team at [email protected]

Practical Solutions Newsletter

Dissolution Hotline


Part Number Index

10-2429 .........................................................................691001-1017.....................................................................721001-1018.....................................................................721001-1020.....................................................................721002-0383.....................................................................551002-0384.....................................................................551005-1670.....................................................................761005-1671.....................................................................761005-1672.....................................................................761005-1673.....................................................................761005-1674.....................................................................761005-1687.....................................................................761005-1688.....................................................................761005-1692.....................................................................761005-1693.....................................................................761005-1694.....................................................................761005-1695.....................................................................761005-1696.....................................................................761005-1722.....................................................................761005-1729.....................................................................761005-1778.....................................................................761005-1779.....................................................................761005-1780.....................................................................761005-1781.....................................................................761005-1782.....................................................................761005-1783.....................................................................761005-1784.....................................................................761005-1785.....................................................................761005-1786.....................................................................761005-1787.....................................................................761005-1788.....................................................................761005-1789.....................................................................761005-1790.....................................................................761005-1791.....................................................................761005-1792.....................................................................761005-1793.....................................................................761005-1794.....................................................................761005-1812 ..............................................................21, 411005-1813 ..............................................................21, 411005-1881.....................................................................761005-1882.....................................................................761005-1883.....................................................................761005-1884.....................................................................761005-1885.....................................................................761005-1886.....................................................................761005-1887.....................................................................761005-1888.....................................................................761005-1891.....................................................................771005-1892.....................................................................771005-1893.....................................................................771005-1894.....................................................................771005-1897.....................................................................211005-1898 ..............................................................21, 411005-1899 ..............................................................21, 411005-1900 ..............................................................21, 411005-1901.....................................................................771005-1902.....................................................................771005-1903.....................................................................771005-1904.....................................................................771005-1905.....................................................................771005-1906.....................................................................771005-1907.....................................................................771005-1908.....................................................................771005-1920 ..............................................................20, 771005-1921 ..............................................................20, 771005-1922 ..............................................................20, 77

1005-1923 ..............................................................20, 771005-1945.....................................................................771005-1946.....................................................................771005-1952.....................................................................771005-1953.....................................................................771005-1954.....................................................................7711-0017 .........................................................................6211-0035 .........................................................................5811-0060 .......................................................................10211-1010 .......................................................................10111-1011 .......................................................................10211-1012 .......................................................................10211-1014 .......................................................................10211-1015 .......................................................................10111-1020 .......................................................................10111-1030 .......................................................................10111-1125...............................................................101-10211-1131 .......................................................................10111-1132 .......................................................................10111-1133 .......................................................................10111-1134 ..............................................................101, 10311-1135 .......................................................................10111-1136 .......................................................................10111-1137 .......................................................................10211-1138 .......................................................................10211-1139 .......................................................................10211-1140 .......................................................................10211-1141 .......................................................................10211-1142 .......................................................................10111-1226 .......................................................................10111-1300 .......................................................................10111-1301 .......................................................................10111-1302 .......................................................................10111-1305 .......................................................................10111-1310 .......................................................................10111-1315 .......................................................................10111-1320 .......................................................................10111-1325 .......................................................................10111-1412 .......................................................................10211-1413 .......................................................................10211-1414 .......................................................................10211-1424 .......................................................................10211-1425...............................................................102-10311-1426 .......................................................................10211-1429 .......................................................................10211-1430 .......................................................................10211-1435...............................................................102-10311-1440 .......................................................................10211-1445 .......................................................................10211-1450 .......................................................................10212-0040 .........................................................................6912-0200 .........................................................................3712-0205 .........................................................................3712-0301 .........................................................................3112-0302 .........................................................................3112-0304 .........................................................................3112-0305 .........................................................................3112-0306 .........................................................................3112-0308 .........................................................................3212-0309 .........................................................................3112-0311 .........................................................................3112-0312 .........................................................................3212-0313...................................................................31, 4512-0314 .........................................................................3212-0316 .........................................................................3112-0317 .........................................................................31

12-0318 .........................................................................3112-0319 .........................................................................3112-0320...................................................................31, 6812-0321...................................................................31, 6812-0400 .........................................................................3112-0420 .........................................................................3112-0447 .........................................................................3612-0450 .........................................................................3612-0455 .........................................................................3612-0460 .........................................................................3612-0463 .........................................................................4112-0464 .........................................................................4112-0465 .........................................................................3612-0467 .........................................................................3612-0468 .........................................................................3612-0531....................................................................65-6612-0540 .........................................................................6612-0550 .........................................................................6512-0560 .........................................................................6512-0580 .........................................................................6512-0592 .......................................................................10212-0601 .........................................................................3712-0606 .........................................................................3712-0611 .........................................................................3712-0616 .........................................................................3712-0651 .........................................................................3712-0656 .........................................................................3712-0661 .........................................................................3712-0666 .........................................................................3712-1000 .........................................................................2512-1000V.......................................................................2512-1005 .........................................................................2512-1005V.......................................................................2512-1010 .........................................................................2512-1010V.......................................................................2512-1015 .........................................................................2512-1015V.......................................................................2512-1030 .........................................................................2512-1030V.......................................................................2512-1035 .........................................................................2512-1035V.......................................................................2512-1040 .........................................................................2512-1040V.......................................................................2512-1045 .........................................................................2512-1045V.......................................................................2512-1200 .........................................................................2512-1201 .........................................................................2512-1201V.......................................................................2512-1205 .........................................................................2512-1211 .........................................................................2512-1211V.......................................................................2512-1216 .........................................................................2512-1216V.......................................................................2512-1228 .........................................................................2512-1228V.......................................................................2512-1229 .........................................................................2512-1300 .........................................................................2512-1305 .........................................................................2512-1306 .........................................................................2512-1307 .........................................................................2512-1310 .........................................................................2512-1315 .........................................................................2512-1316 .........................................................................2512-1317 .........................................................................2512-1318 .........................................................................2512-1320 .........................................................................26


Part Number Index

12-1330 .........................................................................2612-1350 .........................................................................2612-1352 .........................................................................2112-1360 .........................................................................4312-1360V.......................................................................4312-1365 .........................................................................4312-1370...................................................................43, 4512-1371 .........................................................................4312-1371V.......................................................................4312-1372 .........................................................................4312-1380 .........................................................................4312-1385 .........................................................................4312-1420...................................................................17, 2612-1420V................................................................17, 2612-1421...................................................17, 26, 72, 10312-1421V .........................................................14, 17, 2612-1430............................................................17, 26, 7212-1430V................................................................17, 2612-1431...................................................................17, 2612-1431V.......................................................................2612-1432...................................................................17, 2612-1433 ..............................................................9, 17, 2612-1433V .........................................................14, 17, 2612-1436...................................................................17, 2612-1436V................................................................17, 2612-1437 ..............................................................9, 17, 2612-1437V................................................................17, 2612-1438 ..............................................................9, 17, 2612-1438V................................................................17, 2612-1439...................................................................17, 2612-1439V.......................................................................2612-1440...................................................................17, 2612-1441...................................................................17, 2612-1441V.......................................................................2612-1442...................................................................17, 2612-1442V.......................................................................2612-1443............................................................17, 26, 4512-1443V.......................................................................2612-1450............................................................19, 29, 3212-1451............................................................19, 29, 3212-1452...................................................................19, 2912-1500...................................................................19, 2912-1500V................................................................19, 2912-2000 .........................................................................2312-2000V.......................................................................2312-2010 .........................................................................2312-2020 .........................................................................2312-2020V.......................................................................2312-2025 .........................................................................2312-2025V.......................................................................2312-2030 .........................................................................2312-2040 .........................................................................2312-2041 .........................................................................2312-2041V.......................................................................2312-2042 .........................................................................2312-2043 .........................................................................2312-2044 .........................................................................2312-2045 .........................................................................2312-2050 .........................................................................2312-2053 .........................................................................2312-2055 .........................................................................2312-2056 .........................................................................2312-2057 .........................................................................2312-2060 .........................................................................2412-2061 .........................................................................2412-2062 .........................................................................24

12-2063 .........................................................................2412-2064 .........................................................................2412-2069 .........................................................................2412-2070 .........................................................................2312-2070V.......................................................................2312-2073 .........................................................................2312-2073V.......................................................................2312-2075 .........................................................................2312-2076 .........................................................................2312-2077 .........................................................................2312-2078 .........................................................................2312-2079 .........................................................................2312-2080 .........................................................................2312-2080V.......................................................................2312-2081 .........................................................................2312-2085 .........................................................................2312-2086 .........................................................................2312-2090 .........................................................................2312-2091 .........................................................................2412-2093 .........................................................................2312-2095 .........................................................................2412-2095V.......................................................................2412-2096.............................................................23-24, 2612-2097 .........................................................................2312-2098 .........................................................................2412-2099.............................................................23-24, 2612-2100.................................................9, 17, 24, 56, 7212-2100V................................................................17, 2412-2102...................................................................17, 2412-2102V.......................................................................2412-2103 .........................................................................2412-2104 .........................................................................2412-2105 .........................................................................2412-2110 .........................................................................2412-2115...................................................................17, 2412-2116...................................................................17, 2412-2120 .........................................................................2412-2120V.......................................................................2412-2125 .........................................................................2412-2130 .........................................................................2412-2140 .........................................................................2412-2145 .........................................................................2412-2146 .........................................................................2412-2148 .........................................................................2412-2149 .........................................................................2412-2150 .........................................................................2412-2151 .........................................................................2412-2152 .........................................................................2412-2154 .........................................................................2412-2155 .........................................................................2412-2160...................................................................17, 2412-2180 .........................................................................2412-2185 .........................................................................2412-3000 .........................................................................3312-3050 .........................................................................3312-3055 .........................................................................3312-3056 .........................................................................3312-3060 .........................................................................3312-3062 .........................................................................3312-3063 .........................................................................3312-3064 .........................................................................3312-3065 .........................................................................3312-3066 .........................................................................3312-3067 .........................................................................3312-3068 .........................................................................3312-3072 .........................................................................33

12-3200 .........................................................................3512-3210 .........................................................................3512-3215 .........................................................................3512-3216 .........................................................................3512-3217 .........................................................................3512-3218 .........................................................................3512-3219 .........................................................................3512-3220 .........................................................................3512-3230 .........................................................................3512-3240 .........................................................................3512-3250 .........................................................................3512-4000 .........................................................................4512-4001 .........................................................................4512-4002 .........................................................................4512-4005 .........................................................................4512-4010 .........................................................................4512-4011 .........................................................................4512-4012 .........................................................................4512-4015 .........................................................................4512-4050 .........................................................................4312-4055 .........................................................................4312-4060 .........................................................................4312-4100 .........................................................................4712-4101 .........................................................................4712-4105 .........................................................................4712-4110 .........................................................................4712-4111 .........................................................................4712-4120 .........................................................................4712-4130 .........................................................................4712-4140 .........................................................................4712-4150 .........................................................................4712-4200 .........................................................................4312-4200V.......................................................................4312-4201 .........................................................................4312-4209 .........................................................................4312-4210 .........................................................................4312-4211 .........................................................................4312-4230 .........................................................................4312-4231 .........................................................................4312-4232 .........................................................................4312-4300 .........................................................................4312-4310 .........................................................................4312-4320 .........................................................................4312-4330 .........................................................................4312-4400 .........................................................................4312-4410 .........................................................................4312-5000 .........................................................................2812-5000V.......................................................................2812-5010 .........................................................................2812-5010V.......................................................................2812-5033...................................................................28, 3212-5034...................................................................28, 3212-5035 .........................................................................2812-5035V.......................................................................2812-5039 .........................................................................2812-5039V.......................................................................2812-5040 .........................................................................2812-5041 .........................................................................2812-5050 .........................................................................2812-5051 .........................................................................2812-5055 .........................................................................2812-5065 .........................................................................2812-5070 .........................................................................2812-5070V.......................................................................2812-5075 .........................................................................2812-5120 .........................................................................28


Part Number Index

12-5120V.......................................................................2812-5125 .........................................................................2812-5130 .........................................................................2812-5145...................................................................19, 2912-5146...................................................................19, 2912-5147...................................................................19, 2912-5148...................................................................19, 2912-5149...................................................................19, 2912-5149V................................................................19, 2912-5152...................................................................19, 2912-5152V................................................................19, 2912-5153...................................................................19, 2912-5154...................................................................19, 2912-5157..............................................................9, 19, 2912-5157V................................................................19, 2912-5158...................................................................19, 2912-5158V................................................................19, 2912-5159...................................................................19, 2912-5170............................................................19, 29, 4512-5200 .........................................................................2812-5200V.......................................................................2812-5500 .........................................................................2812-5505 .........................................................................2812-5510 .........................................................................2812-6050 .........................................................................4012-6060 .........................................................................4012-6062 .........................................................................4012-6065 .........................................................................4012-6070 .........................................................................4012-6100 .........................................................................3112-6100V.......................................................................3112-6101 .........................................................................3112-6115 .........................................................................4012-6200 .........................................................................4112-6205 .........................................................................4112-6300 .........................................................................4112-6301 .........................................................................4112-6305 .........................................................................4112-6306 .........................................................................4112-6310 .........................................................................4112-6311 .........................................................................4112-6315...................................................................31, 4112-6320 .........................................................................4112-6325 .........................................................................4112-6326 .........................................................................4112-6327 .........................................................................4112-6328 .........................................................................4112-6329 .........................................................................4112-6330 .........................................................................4112-6350 .........................................................................4112-6352 .........................................................................4112-6353 .........................................................................4112-6358 .........................................................................4112-6362 .........................................................................4112-6363 .........................................................................4112-6365...................................................................21, 4112-6368 .....................................................19, 29, 32, 4512-6370...................................................................21, 4112-7020 .........................................................................6912-7100 .........................................................................6912-7110 .........................................................................6912-7120 .........................................................................6912-7200 .........................................................................6812-7210 .........................................................................6812-7220 .........................................................................6812-7230 .........................................................................69

12-7240 .........................................................................6812-7250 .........................................................................6812-7250V.......................................................................6812-7260 .........................................................................6812-7260V.......................................................................6812-7270 .........................................................................6812-7270V.......................................................................6812-7280 .........................................................................6812-7280V.......................................................................6812-7300 .........................................................................6912-7300V.......................................................................6912-7301 .........................................................................6912-7301V.......................................................................6912-7310 .........................................................................6912-7310V.......................................................................6912-7311 .........................................................................6912-7325 .........................................................................6912-7330 .........................................................................6912-7330V.......................................................................6912-7335...................................................................43, 6812-7500 .........................................................................6512-7502 .........................................................................6612-7505 .........................................................................6512-7520 .........................................................................6912-9005 .........................................................................6512-9010 .........................................................................6512-9015 .........................................................................6512-9020 .........................................................................6512-9021 .........................................................................6512-9025 .........................................................................6512-9988 .........................................................................2112-9989 .........................................................................2112-9995 .........................................................................6512-9996 .........................................................................6512-9997 .........................................................................651200-1012 ..............................................................21, 4115-1000....................................................................72-7315-1020....................................................................72-7315-1100....................................................................72-7315-1120....................................................................72-7315-1400 .........................................................................7315-1410...................................................................72, 7415-1420...................................................................72, 7415-1441...................................................................72, 7415-1442...................................................................72, 7415-1500....................................................................72-7315-2000....................................................................72-7315-2020....................................................................72-7315-2100....................................................................72-7315-2120....................................................................72-7315-2400....................................................................72-7315-2410...................................................................72, 7415-2420...................................................................72, 7415-2500....................................................................72-7315-3600....................................................................72-7315-3610....................................................................72-7315-3620....................................................................72-7315-3630....................................................................72-7315-3640....................................................................72-7315-3650....................................................................72-7315-3660....................................................................72-7315-3670....................................................................72-7315-3680....................................................................72-7315-3690....................................................................72-7315-3700....................................................................72-7315-3710....................................................................72-73

15-4000 .........................................................................7715-4100 .........................................................................7715-4400 .........................................................................7715-4500 .........................................................................7715-5002 .........................................................................7915-5004 .........................................................................7915-5006 .........................................................................7915-5008 .........................................................................7915-5100 .........................................................................7815-5101 .........................................................................7815-5110 .........................................................................7815-5111 .........................................................................7815-7000....................................................................72-7315-7020....................................................................72-7315-7040....................................................................72-7315-7100....................................................................72-7315-7120....................................................................72-7315-7140....................................................................72-7315-7155...................................................................72, 7415-7165...................................................................72, 7415-8030 .........................................................................7315-8035 .........................................................................7315-8040 .........................................................................7315-8045 .........................................................................7316-6100............................................................................816-6200............................................................................816-6300............................................................................816-6400............................................................................816-6500.....................................................................8, 9416-6600............................................................................816-6700............................................................................816-6800.....................................................................8, 9416-6900...................................................................8, 10316-7000............................................................................816-7100.....................................................................8, 9416-7200 .........................................................................1416-7300 .........................................................................1416-7400 .........................................................................1416-7500...................................................................14, 9416-7600...................................................................14, 7216-7700...................................................................14, 9417-0110 .........................................................................7417-1000 .........................................................................7417-1010 .........................................................................7417-1015 .........................................................................7417-1020 .........................................................................7417-1030 .........................................................................7417-1040 .........................................................................7417-1050 .........................................................................7417-1060 .........................................................................7417-1061 .........................................................................7417-1065 .........................................................................7417-1070 .........................................................................7417-1075 .........................................................................7417-1080 .........................................................................7417-1200 .........................................................................7417-1300 .........................................................................7417-1310 .........................................................................7417-1340 .........................................................................2117-1345 .........................................................................2117-1351...................................................................21, 7417-1400 .........................................................................7417-1500 .........................................................................7417-2000 .........................................................................8117-2100 .........................................................................8117-2200 .........................................................................81


Part Number Index

17-2300 .........................................................................8117-2600 .........................................................................8117-2700 .........................................................................8117-3000 .........................................................................3717-3005 .........................................................................3717-3015 .........................................................................3717-3030 .........................................................................3717-3100 .........................................................................3717-3102 .........................................................................3717-3107 .........................................................................3717-3111 .........................................................................3717-3112...................................................................37, 4517-3113 .........................................................................3717-3115 .........................................................................3717-3116 .........................................................................3717-3117 .........................................................................3717-3120 .........................................................................3717-3121 .........................................................................3717-3140 .........................................................................3717-3141 .........................................................................3717-3142 .........................................................................3717-3143 .........................................................................3717-3150 .........................................................................3517-3300...................................................................36, 7517-3305...................................................................36, 7517-3306...................................................................36, 7517-3307...................................................................36, 7517-3309...................................................................36, 7517-3310...................................................................36, 7517-3311...................................................................36, 7517-3312...................................................................36, 7517-3313...................................................................36, 7517-3314...................................................................36, 7517-3317...................................................................36, 7517-3320...................................................................36, 7517-3330 .........................................................................3617-3335 .........................................................................3617-4000 .........................................................................3917-4001 .........................................................................3917-4005 .........................................................................3917-4010 .........................................................................3917-4011 .........................................................................3917-4015 .........................................................................3917-4020 .........................................................................3917-4021 .........................................................................3917-4025 .........................................................................3917-4040 .........................................................................3917-4045 .........................................................................3917-4050 .........................................................................3917-4055 .........................................................................3917-4100 .........................................................................3917-4110 .........................................................................3917-4120 .........................................................................3917-4130 .........................................................................3917-4140 .........................................................................3917-4150 .........................................................................3817-4151 .........................................................................3817-4152 .........................................................................3817-4153 .........................................................................3817-4154 .........................................................................3817-4155 .........................................................................3817-4156 .........................................................................3817-4157 .........................................................................3817-4159 .........................................................................3817-4160 .........................................................................3817-4161 .........................................................................38

17-4165 .........................................................................3817-4195 .........................................................................3917-5001 .........................................................................7517-5010 .........................................................................7517-5020 .........................................................................7517-5030...................................................................58, 7517-5035 .........................................................................7517-5040 .........................................................................7517-5100 .........................................................................7417-6000...................................................................75, 8117-6005...................................................................75, 8117-6010...................................................................75, 8117-6020...................................................................74, 8117-6021 .........................................................................7417-6022 .........................................................................7417-6030...................................................................75, 8117-6031...................................................................75, 8117-6035...................................................................75, 8117-6038 .........................................................................7517-6050 .........................................................................7417-6070 .........................................................................7417-6100 .........................................................................7517-6110 .........................................................................7517-6200 .........................................................................7517-6210 .........................................................................7520-6200 .........................................................................8320-6300 .........................................................................8320-6310 .........................................................................8320-6510 .........................................................................8320-6515 .........................................................................8320-6540 .........................................................................8320-6545 .........................................................................8320-6580 .........................................................................8320-6585 .........................................................................8320-6610 .........................................................................8320-6615 .........................................................................8320-6650 .........................................................................8320-6655 .........................................................................8320-6670 .........................................................................8320-6675 .........................................................................8320-6680 .........................................................................8320-6685 .........................................................................8320-6690 .........................................................................8320-6695 .........................................................................8320-6700 .........................................................................8320-6705 .........................................................................8320-6710 .........................................................................8320-6715 .........................................................................8320-6720 .........................................................................8320-6725 .........................................................................8325-1000 .........................................................................5125-1100 .........................................................................5125-2000 .........................................................................5525-2100 .........................................................................5525-2490 .........................................................................5525-2495 .........................................................................5525-2500 .........................................................................5525-2600 .........................................................................5527-0100 .........................................................................5527-0101....................................................................55-5627-0102....................................................................55-5627-0103....................................................................55-5627-0104....................................................................55-5627-0105 .........................................................................5527-0106 .........................................................................5527-0107 .........................................................................55

27-0108 .........................................................................5527-0109 .........................................................................5527-1000 .........................................................................5227-1010 .........................................................................5227-1020 .........................................................................5227-1030 .........................................................................5227-1050 .........................................................................5227-1500 .........................................................................5227-1510 .........................................................................5227-1520 .........................................................................5227-2000 .........................................................................5327-2005 .........................................................................5327-2007 .........................................................................5327-2010 .........................................................................5327-2015 .........................................................................5327-2099 .........................................................................5327-2100 .........................................................................5327-2103 .........................................................................5327-2105 .........................................................................5327-2110 .........................................................................5327-2115 .........................................................................5327-2120 .........................................................................5327-2125 .........................................................................5327-2200 .........................................................................5327-2205 .........................................................................5327-2210 .........................................................................5327-2215 .........................................................................5327-2300 .........................................................................5327-2305 .........................................................................5327-2310 .........................................................................5327-2315 .........................................................................5327-2320 .........................................................................5327-2400...................................................................53, 5627-2401...................................................................53, 5627-3000....................................................................55-5627-3001....................................................................55-5627-3002....................................................................55-5627-5000...................................................................52, 5627-5010...................................................................52, 5627-5100 .........................................................................5227-5110 .........................................................................5227-5111 .........................................................................5227-5112 .........................................................................5227-5120 .........................................................................5227-5130 .........................................................................5527-5135 .........................................................................5527-5160 .........................................................................5527-5170 .........................................................................5227-6000 .........................................................................5227-6005 .........................................................................5227-6010 .........................................................................5227-6100 .........................................................................5127-6105 .........................................................................5127-6200 .........................................................................5127-6201 .........................................................................5127-6202 .........................................................................5127-6203 .........................................................................5127-6204 .........................................................................5127-6205 .........................................................................5127-6500 .........................................................................5227-6520 .........................................................................5227-6540 .........................................................................5627-6541 .........................................................................5627-6542 .........................................................................5627-6543 .........................................................................5627-8005....................................................................55-56


Part Number Index

27-8010 ...................................................................55-5627-8015 ...................................................................55-5627-8020 ...................................................................55-5627-8025 ...................................................................55-5627-8035 ...................................................................55-5627-8036 ...................................................................55-5627-8600 ...................................................................55-5627-8620 ...................................................................55-5627-8621 ...................................................................55-5627-8622 ...................................................................55-5630-1000 .........................................................................6130-1100 .........................................................................6130-1200 .........................................................................6130-1300 .........................................................................6132-0110 .........................................................................6132-0120 .........................................................................6132-1101 .........................................................................6132-1105 .........................................................................6132-1121 .........................................................................6132-1125 .........................................................................6132-1201 .........................................................................6132-1205 .........................................................................6132-1221 .........................................................................6132-1225 .........................................................................6132-1300 .........................................................................6132-1301 .........................................................................6132-1302 .........................................................................6132-1305 .........................................................................6132-5001 .........................................................................6132-5021 .........................................................................6132-5030 .........................................................................6132-5521 .........................................................................6132-5530 .........................................................................6133-0105 .........................................................................5833-0106 .........................................................................5833-0505 .........................................................................5833-0506 .........................................................................5833-9000 .........................................................................5833-9001 .........................................................................5833-9002 .........................................................................5833-9005 .........................................................................5833-9006 .........................................................................5833-9007 .........................................................................5833-9009 .........................................................................5933-9010 .........................................................................5833-9012 .........................................................................5933-9013 .........................................................................5833-9022 .........................................................................5933-9025 .........................................................................5933-9029 .........................................................................5933-9030 .........................................................................5833-9040 .........................................................................5833-9041 .........................................................................5933-9042 .........................................................................5933-9043 .........................................................................5833-9044 .........................................................................5833-9046 .........................................................................5933-9047 .........................................................................5933-9048 .........................................................................5933-9049 .........................................................................5933-9050 .........................................................................5935-4000 .......................................................................10935-4100 .......................................................................10935-4200 .......................................................................10935-4300 .......................................................................10937-0150 .......................................................................111

37-0155 .......................................................................11137-0200 .......................................................................11137-1040 .......................................................................11037-2001 .......................................................................10937-2001V ....................................................................10937-2010 .......................................................................10937-2020 .......................................................................10937-2025 .......................................................................10937-2030 .......................................................................10937-2040 .......................................................................10937-2050 .......................................................................10937-2060 .......................................................................10937-2100 .......................................................................11037-2105 .......................................................................11037-2110 .......................................................................11037-2200 .......................................................................11037-2205 .......................................................................11037-2210 .......................................................................11037-3001 .......................................................................10937-3001V ....................................................................10937-3010 .......................................................................10937-3020 .......................................................................10937-3030 .......................................................................10937-3030V ....................................................................10937-3040 .......................................................................10937-3050 .......................................................................10937-4000 .......................................................................11037-4000V ....................................................................11037-4010 .......................................................................11037-4020 .......................................................................11037-4100 .......................................................................11037-4110 .......................................................................11037-4120 .......................................................................11037-5000 .......................................................................11037-5000V ....................................................................11037-5005 .......................................................................11037-5010 .......................................................................11037-5200 .......................................................................11037-5305 .......................................................................11037-5305V ....................................................................11037-6000 .......................................................................11037-6010 .......................................................................11037-9000 .......................................................................11040-2000 .......................................................................11340-2010 .......................................................................11340-2011 .......................................................................11340-2012 .......................................................................11340-2100 .......................................................................11340-2110 .......................................................................11340-2111 .......................................................................11340-2112 .......................................................................11340-2200 .......................................................................11340-2300 .......................................................................11342-0120 .......................................................................11542-0160 .......................................................................11542-0162 .......................................................................11542-0164 .......................................................................11542-0166 .......................................................................11542-0250 .......................................................................11442-0300 .......................................................................11442-0350 .......................................................................11442-0355 .......................................................................11442-1000 .......................................................................11442-1005 .......................................................................11442-1010 .......................................................................11442-1015 .......................................................................114

42-1020 .......................................................................11442-1025 .......................................................................11442-1030 .......................................................................11442-1035 .......................................................................11442-1040 .......................................................................11442-1050 .......................................................................11442-1200 .......................................................................11342-1205 .......................................................................11342-1210 .......................................................................11342-1215 .......................................................................11342-1220 .......................................................................11342-1225 .......................................................................11342-1230 .......................................................................11342-2000 .......................................................................11342-2005 .......................................................................11342-2010 .......................................................................11442-2020 .......................................................................11342-2030 .......................................................................11442-6105 .......................................................................11442-6110 .......................................................................11445-1000 .......................................................................11745-1200 .......................................................................11745-1300 .......................................................................11745-1400 .......................................................................11745-2000 .......................................................................11745-2100 .......................................................................11745-2200 .......................................................................11745-2300 .......................................................................11745-2350 .......................................................................11747-0120 .......................................................................11747-0153...............................................................117-11847-1000 .......................................................................11847-1000V ....................................................................11847-1005 .......................................................................11847-1005V ....................................................................11847-1010 .......................................................................11847-1010V ....................................................................11847-1015 .......................................................................11847-1015V ....................................................................11847-1020 .......................................................................11847-1030 .......................................................................11850-1000 .......................................................................12050-1100 .......................................................................12050-1800 .......................................................................12050-1810 .......................................................................12050-2000 .......................................................................12050-2100 .......................................................................12050-3000 .......................................................................12050-3100 .......................................................................12052-0120 .......................................................................12052-0153 .......................................................................12052-1000 .......................................................................12152-1010 .......................................................................12152-1020 .......................................................................12152-1030 .......................................................................12152-1040 .......................................................................12152-1050 .......................................................................12152-1060 .......................................................................12152-1070 .......................................................................12152-1080 .......................................................................12152-2010 .......................................................................12152-5000 .......................................................................12152-5010 .......................................................................12152-5020 .......................................................................12152-5040 .......................................................................12152-5050 .......................................................................121


Part Number Index

52-5060 .......................................................................12160-1000 .........................................................................4960-1100 .........................................................................4960-1200 .........................................................................4960-1300 .........................................................................4960-1400 .........................................................................4960-1500 .........................................................................4960-2000 .........................................................................4960-2020 .........................................................................4960-2100 .........................................................................4960-2110 .........................................................................4960-2120 .........................................................................4960-2200 .........................................................................4960-2250 .........................................................................4960-2300 .........................................................................4960-2400 .........................................................................4960-2500 .........................................................................4960-2600 .........................................................................4962-9000 .........................................................................4962-9010 .........................................................................4962-9020 .........................................................................4962-9025 .........................................................................4962-9030 .........................................................................4962-9040 .........................................................................4965-3000 .........................................................................4965-3100 .........................................................................4965-3800 .........................................................................4965-3810 .........................................................................4965-3820 .........................................................................4965-3830 .........................................................................4965-3850...................................................................21, 4967-0300 ................................................................21, 11070-4920 .......................................................................12670-4935 .......................................................................12670-6953 .......................................................................12570-6955 .......................................................................12570-6960 .......................................................................12470-7110 .......................................................................13370-7111 .......................................................................13376-2000 .......................................................................12476-2001 .......................................................................12476-2100 .......................................................................12476-2101 .......................................................................12476-2200 .......................................................................12476-2201 .......................................................................12476-3010 .......................................................................12476-3011 .......................................................................12476-3018 .......................................................................12676-3019 .......................................................................12676-3022 .......................................................................12676-3023 .......................................................................12676-3024 .......................................................................12676-3037 .......................................................................12476-3038 .......................................................................12476-3042 .......................................................................12476-3043 .......................................................................12576-3044 .......................................................................12576-3046 .......................................................................12576-3047 .......................................................................12576-3052 .......................................................................12576-3053 .......................................................................12576-3054 .......................................................................12576-3058 .......................................................................12576-3059 .......................................................................12576-3061 .......................................................................12576-3062 .......................................................................125

76-3067 .......................................................................12776-3068 .......................................................................12776-3070 .......................................................................12776-3071 .......................................................................12776-3073 .......................................................................12776-3074 .......................................................................12776-3076 .......................................................................12776-3077 .......................................................................12789068D..........................................................................92G1118AA................................................................92, 94G1127A...................................................................92, 94G1128A...................................................................92, 94G1129A...................................................................92, 94G1130A .........................................................................92G1811A .........................................................................92G1812AA ......................................................................92G1815AA................................................................92, 94G7900AA................................................................92, 94G7920A .........................................................................93G7921A .........................................................................93G7922A .........................................................................93K1000-02100 ................................................................10K1000-02200 ................................................................10K1000-02300 ................................................................10K1000-02400 ................................................................10K1000-02600 ................................................................15K1000-04100 ................................................................10K1000-04200 ................................................................10K1000-04300 ................................................................10K1000-04400.............................................................9-10K1000-04600 ..........................................................14-15K1001-01128 ................................................................15K1001-01129 ................................................................15K1001-01130 ................................................................15K1001-01131 ..........................................................14-15K1001-01160....................................................14-15, 21K1001-01161 .........................................................15, 21K1001-01171 .........................................................10, 20K1001-01172 .........................................................10, 20K1001-01173 .........................................................11, 20K1001-01174 .........................................................11, 20K1001-01175 .........................................................11, 20K1001-01176 .........................................................11, 20K1001-01177 .........................................................10, 20K1001-01178 .........................................................10, 20K1001-01179 .........................................................11, 20K1001-01180 .........................................................11, 20K1001-01181 .........................................................11, 20K1001-01182 .........................................................11, 20K1001-01183 .........................................................10, 20K1001-01184 .........................................................10, 20K1001-01185 .........................................................11, 20K1001-01186 .........................................................11, 20K1001-01187.....................................................9, 11, 20K1001-01188 .........................................................11, 20K1001-01189 .........................................................11, 20K1001-01190 .........................................................11, 20K1001-01191 .........................................................11, 20K1001-01192 .........................................................11, 20K1001-01193...................................................11, 21, 36K1001-01194...................................................11, 21, 36K1001-01195...................................................11, 21, 36K1001-01196...................................................11, 21, 36K1001-01197 .........................................................10, 20K1001-01198 .........................................................10, 20K1001-01199 .........................................................11, 20K1001-01200 .........................................................11, 20K1005-01568 ................................................................21

K1005-01829............................................................9, 11K1005-01871 .........................................................10, 15K1005-01872 .........................................................10, 15K1005-01873................................................9-10, 14-15K1005-01874 .........................................................10, 15K1005-01875 .........................................................10, 15K1005-01876 .........................................................10, 15K1005-01909 ................................................................11K1005-01912 ................................................................11K1005-01915 ................................................................11K1005-01916 ................................................................11K1005-01924 ................................................................11K1005-01939 ................................................................11K1005-01940 ................................................................11K1005-01944 ................................................................10K1005-01963 .........................................9-10, 14-15, 21K1005-01964 .........................................................10, 15K1005-01968 ................................................................11K1005-01971 ................................................................14K1005-01987 .........................................................10, 15K1005-01989 ................................................................10K1005-01990 ................................................................10K1005-02009 ................................................................15K1005-02010 ................................................................15R1009A .......................................................................126R1009A #001 ............................................................126R1009A #002 ............................................................126R1010A .......................................................................126R1010A #001 ............................................................126R1010A #002 ............................................................126R1010A #003 ............................................................126SYS-DI-400 2B9 ........................................................125SYS-DI-400 2N9........................................................125SYS-DI-7010 2B9......................................................124SYS-DI-7010 2M9.....................................................124SYS-DI-7010 2N9......................................................124SYS-DI-7010 2P9 ......................................................124SYS-DI-7025 2B9......................................................124SYS-DI-7025 2M9.....................................................124SYS-DI-7025 2N9......................................................124SYS-DI-7025 2P9 ......................................................124SYS-DI-7030 2B9......................................................124SYS-DI-7030 2M9.....................................................124SYS-DI-7030 2N9......................................................124SYS-DI-7030 2P9 ......................................................124SYS-DI-705 2B9 ........................................................124SYS-DI-705 2M9 .......................................................124SYS-DI-705 2N9........................................................124SYS-DI-705 2P9.........................................................124SYS-DI-708 2B9 ........................................................124SYS-DI-708 2M9 .......................................................124SYS-DI-708 2N9........................................................124SYS-DI-708 2P9.........................................................124SYS-DI-905 2B9 ........................................................127SYS-DI-905 2N9........................................................127SYS-DI-APP7 2B9.....................................................125SYS-DI-APP7 2N9 ....................................................125SYS-DI-BIO 2B9........................................................125SYS-DI-BIO 2N9........................................................125SYS-DI-BIO 2P9 ........................................................125SYS-DI-PHYS 2B9 ....................................................127SYS-DI-PHYS 2N9 ....................................................127SYS-DI-RBOT 2B9....................................................125SYS-DI-RBOT 2N9....................................................125SYS-UV-VIS R22B091 ..............................................126SYS-UV-VIS R22N091..............................................126SYS-UV-VIS-E R22B091...........................................126SYS-UV-VIS-E R22N091 ..........................................126


Alphabetical Index

1 ........................................................................10-degree Lift (Wedge) ............................116, 118100 Automated Disintegration

Apparatus ............................49, 108-111, 127100 mL Conversion Kit ..................................31-321220 Infinity LC System....................................1071260 Infinity LC System....................................1061290 Infinity LC System....................................106

221 CFR Part 11...........7, 57, 62, 64, 86-87, 92, 992L

708-DS Dissolution Apparatus.............9-11,Conversion Kit ........................................30-31Vessel .................................18-20, 26, 28-29, ...............................................36, 49, 69, 73-77

200 mL Conversion Kit ..............18-19, 29-32, 45,.........................................................93-94, 104

200 Tablet Hardness Tester .............112-115, 127250 Friability Tester...........................116-118, 127

3350 Tapped Density Tester ..............119-121, 1273-fin Basket........................................13, 16-17, 24

4400-DS Apparatus 7..........................5, 57-59, 125

5/6500 mL Sampling Kit ..................11, 21, 34-36, 755010 Height/Center Qualification

Station .....................................................65-66

7705-DS Dissolution Apparatus – Discontinued,

see 708-DS Dissolution Apparatus708-DS Dissolution Apparatus .........5-11, 16-22,

.................................25-27, 29-30, 32, 34, 36,

..............................................41-42, 45, 47-49,

.................................62, 67, 70-75, 77, 83-84, ..........................87, 93-94, 102-104, 124, 127

709-DS Dissolution Apparatus .......5, 7-9, 12-22,25-27, 29, 34, 37, 41, 47, 62, 67, 71-72, 75,..........................................84, 93-94, 104, 124

750 Heater/Circulator ...................................48-49

8806 Syringe Pump .....................51, 54, 62, 70-74,

.........................76-79, 82-83, 96-97, 104-105808 Filter Changer...............38, 51, 54, 62, 70-74,

............76, 78-79, 82-83, 85, 96-97, 104-105810 Peristaltic Pump .............7, 62, 70-77, 79-83,

..................................................95-97, 104-1058000 Dissolution Sampling Station...6-7, 34, 51,

.............................54, 62, 70-81, 84-85, 95-97, .................................................103-105, 124, 127

8020 Dissolution Sampling/HPLC Injector ....62,..........................................75, 82-83, 107, 125

8453 UV Dissolution System or Spectrophotometer ..........................7, 84-94, .............................................................104, 126

AAIQ (Analytical Instrument Qualification) ........7,

.....................................................124-127, 134API (Active Pharmaceutical Ingredient) ....5, 46,

...............................................................57, 108Abrasion Drum ..........................................116, 118Acoustic Cabinet.......................................119, 121Acrylic Water Bath ........................................48-49Active Pharmaceutical Ingredient (API) ...........5,

.........................................................46, 57, 108Adhesive, Medical ...............................................42Adjustment Tool.............................44-45, 112-113Alignment Post ................................6, 9-10, 14-15Alignment Tool................................................44-45Alza, Apparatus 7 ................................................55Amber vessel ......11-12, 14-15, 18-19, 21, 27-29,

........................................55, 58, 60-61, 75, 93American Society of Testing and Materials(ASTM) ............................................3-4, 6, 119-123Analytical Instrument Qualification (AIQ) ........7,

.....................................................124-127, 134Apparatus 1 ...........5-6, 16, 22, 44, 62, 68-70, 92,

.............................................123, 128, 133-134Apparatus 2..................5-6, 16, 22, 44, 62, 68-70,

......................................92, 123, 128, 133-134Apparatus 3 .........5, 50-51, 56, 62, 123, 128, 135Apparatus 5 ...................5-6, 42, 62, 70, 128, 131Apparatus 6 ....................5-6, 42, 62, 70, 128, 131Apparatus 75, 42, 48, 54-58, 62, 72, 74, 125, 128ASTM (American Society of Testing and

Materials) ...............................3-4, 6, 119-123Autocalibration Block......................71, 75, 80, 82Automated Sampling, Autosampling,Autosampler .....6-9, 13-15, 20, 30, 34-35, 37-38,

..................57, 62, 70, 72, 91-92, 94, 99, 104Automation Filter .................................................38AutoTemp In-vessel

Temperature Measurement....6-7, 9, 12-14, ........................32, 34, 37, 72, 93-94, 103-104

BBarbed Fitting .......................................................77Barbed Tubing Adapter.......................................49Basket Shaft .................................................5-9, 12Basket Hanger............................................112-113Basket Rack ...............................................109-110Basket Shaft Support Rack .........................21, 26Basket

3-fin .............................................13, 16-17, 24Bolus .................................................16, 23-24Disintegration.....................................108-109Durafit.........................................17, 22-23, 26Gold-plated.............................................16, 24Mesh ....................................5, 16, 23-24, 109Mini .........................16-18, 23-24, 26, 30, 54Rotating Basket ................5-9, 12-14, 16-18, .....................................................20-24, 26, 30Sinker ............................................................33Suppository ...................................16, 24, 109Teflon-coated ...................................16-17, 24Verified.................................8, 14-16, 22, 109

Battery .....................................................66-67, 114

Beaker.........................................................108, 110Bent Cannula ..................................................34-35Bioavailability....................................108, 130, 132BIO-DIS Reciprocating Cylinder

Accessories ............................................48-50Conversion Kit..............................................51Inner Sample Tube ......................................52Lower Cap.....................................................52Outer Media Tube .......................................52Retrofit ..........................................................51Screen ...........................................................53Upper Cap .....................................................52Vessel Carrier ........................................50, 52

Biorelevant/biorelevance ...............5, 50, 54, 129Bolus Baskets ..........................................16, 23-24Brush, Tablet Fragment ...........................112-114Bulkhead Fitting...................................................49Bundle ................................................8, 14, 93, 104

CCOC (Certificate of Conformance).....16, 27, 109Cabinet, Acoustic......................................119, 121Calibration

Fixture...................................................74, 113Tube ...............................................................75Weight.................................................112-113Weight Hanger...................................112-113

CannulaExtension .........................................34, 36, 75Return ....8, 14, 20, 36, 52, 75-77, 88, 96-97Sample/Return ...............................20, 52, 76Sampling ............9, 34, 36, 38-39, 71, 75-77, ............................................................88, 96-97

CapDecanting................................................60-61Viton Liner ..............................................60-61

CapsuleJapanese Sinker Basket .....................33, 41USP Sinker....................................................33Weight...........................................................33Wire ...............................................................33

Carrying Case..................................................64-66Carryover.........................................................96, 98Cartridge, Peristaltic Pump ...................74, 80-81Cary 50 UV Dissolution System –

see Cary 60 UV Dissolution SystemCary 60 UV-visible Spectrophotometer/UVDissolution System ...........2, 7, 78-79, 80, 84-86,

.......................................................95-105, 126Cary 50 UV-visible Spectrophotometer –

see Cary 60 Spectrophotometer/UV Dissolution System

Cary WinUV Dissolution Software.............84-85, ...............................................99-103, 107, 126

Case, Carrying.................................................64-66Cell Changer.............................84, 95-97, 101-102Centering

Ring................................27, 30, 36, 40-41, 69Tool ................................................................69

Certificate of Conformance (COC).....16, 27, 109ChemStation UV-visible Software .......85-87, 89,

.................................................91-93, 107, 126Chinese Pharmacopeia (CP)..................18-19, 29


Alphabetical Index

Clamp, Tubing ................................................48-49Closed-loop......................................................95-97Collector, Sample –

see 8000 Dissolution Sampling StationCollet.............................................23, 25-26, 31, 45Color-coded Tubing .................................20, 76-77Compendial .............4, 33, 57, 128-129, 131, 133, Compliance Service ...................................123-127Conical Head Shaft ...........................17, 22-23, 26Connector............................................................104Controlled Release ............................................131Conventional Filter Tip............................38-39, 79Conversion Kit ..........................................................

100 mL............................19-20, 29-32, 45, 51200 mL.......18-20, 29-32, 45, 61, 93-94, 1042L .......................................................20, 30-31Large-volume ...................................20, 30-31Small-volume..............................19-20, 30-31

Converter.............................................................102Contact Lens.........................................................59Correlating Dissolution and Bioavailability:

Understanding IVIVC Seminar................130Cover, Evaporation ......6-7, 10, 12-15, 18, 21, 27,

.............29-32, 36, 40-41, 45, 52, 57, 59, 102Cream........................................................5, 44, 131Cup, Suspension.............................................42-43Cuprophan ......................................................43, 45Cuvette Holder ......................................89, 91, 102Cylinder Platform .......................................119-121Cylinder, Graduated ...................................119-121

DDDG (Dissolution Discussion Group).............136DDM (Dosage Delivery Module) ......6-10, 13-15,

.............................21, 34, 41, 72, 94, 103-104DVH (Direct Vessel Heating).......................12-15,

...............................................18-19, 21, 27-29Decanting Cap ................................................60-61Depth/Height, Gauge ...................................43, 68Direct Vessel Heating – see DVHDisintegration

100 Automated Disintegration Tester....................................49, 108-111, 127Basket ................................................108-109Beaker .........................................................110Fluted Disks........................................108-110Water Bath...................................................49

Diode-array Spectrophotometer – see 8453 UV Dissolution System or Spectrophotometer

Disk, Plastic ........................................................110Dissolution 1-on-1 CD.......................................133Dissolution and Bioequivalence of

Generic Pharmaceuticals Seminar ........132Dissolution Apparatus

400-DS ........................................5, 57-59, 125708-DS ...........5-11, 16-22, 25-27, 29-30, 32...........................34, 36, 41-42, 45, 47-49, 62,......................67, 70-75 77, 83-84, 87, 93-94,........................................... 102-104, 124, 127709-DS...............5, 7-9, 12-22, 25-27, 29, 34, ..........................37, 41, 47, 62, 67, 71-72, 75, ..........................................84, 93-94, 104, 124Apparatus 1 .........................................5, 6-15

Apparatus 2 .........................................5, 6-15Apparatus 3........................................5, 50-53Apparatus 5..............................5, 6-15, 42-47Apparatus 6 ............................5, 6-15, 42-47Apparatus 7........................................5, 54-49BIO-DIS ................................5, 50-53, 72, 125Paddle Over Disk...............................5, 42-43Reciprocating Cylinder .....................5, 50-53Reciprocating Holder........................5, 54-56Rotating Basket ...................................5, 6-15Rotating Cylinder.....................5, 6-15, 42-47Rotating Paddle ...................................5, 6-15

Dissolution Discussion Group (DDG).............136Dissolution Hotline............................................137Dissolution Method Development and

Validation Seminar....................................129Dissolution Sampling Systems,

Automated ..............................................70-83Dissolution Tester – See Dissolution ApparatusDissolution Workstation Software ......7, 51, 54,

...........................57-58, 62-63, 71, 82-83, 125Dosage/dosage form ..........2, 4-9, 12-14, 18, 22,

..........................27, 33-34, 38, 50, 54, 57, 60,

...............85, 99-100, 108-109, 130, 135, 140Dosage Delivery Module (DDM) ......6-10, 13-15,

............................ 21, 34, 41, 72, 94, 103-104Drain Valve............................................................49Drug-eluting Stent (DES) ...............................5, 57Drug Release ................4, 5, 57, 60, 78, 128, 131, Drum, Friability ...........................................116-118Dual-chamber Friability Drum..................116-118Dual-drum Friability Tester ..............116-118, 127Durafit ................................................17, 22-23, 26Dura-Tef Shaft.......................................................25

EEaseAlign Vessel/Centering Ring .......27-28, 31,

.................................36, 40-41, 45, 64, 67, 69Educational Seminar .................................128-132Electropolished Stainless Steel,

Basket or Paddle ......................9, 14, 17, 22, ............................................25-26, 45, 72, 103

Enhanced Mechanical Calibration –see Mechanical Qualification

Enhancer Cell ..............................5, 28, 44-45, 131Enteric-coated ........................................................5Environmental Chamber ..................12-15, 18, 27Evaporation Cover........6-7, 10, 12-15, 18-21, 27,

................................29-32, 36, 40-41, 45, 102Evaporation Plug......................................21, 40-41Extended Release .................4-5, 50, 54, 57, 135

FFDA (Food and Drug Administration)........3-4, 6,

.......................................................11-123, 135Fiber optic Probe .........................................98, 102Fiber optic UV Dissolution System........103, 126Filter

Automation Filter ........................................38Changer .......38, 51, 72-74, 76, 78-79, 82-83Conventional Filter Tip ...............................38Full Flow Filter ..............34-35, 38-39, 72, 82

Fitting, Water Bath ........................................48-49

Floating Dosage Form.....................................5, 50Flow Cell ..............84, 87-91, 95-97, 101-102, 104Flow Deflector ......................................................49Fluted Disk ..................................................108-109Food and Drug Administration (FDA)........3-4, 6,

.......................................................11-123, 135Fragment Brush ........................................112-114Franz Cell .....................................................44, 131, Friability Testing ................................116-118, 127Full Flow Filter .......................34-35, 38-39, 72, 82Fundamentals of Dissolution Seminar ..........133

GGel ...................................................................5, 44Gauge

Centering ......................................................67Height .....................................................43, 68Wobble.............................................64, 67, 69

Generic Pharmaceuticals .................................132Glass Tube..........................................52, 58, 74-75 Glass Vessel

1L ......................................................5, 93, 104100 mL........................................19, 28-29, 311000 mL – see 1L 2L....................................19, 28-30, 36, 69, 75200 mL .................................18-19, 28, 31, 32Amber .........................................15, 19, 28-29DVH TruAlign ......................12, 18-19, 27, 29EaseAlign..........................................27-28, 40TruAlign ....6-9, 12, 18-19, 27, 29, 32, 40, 45TruCenter....................................27-28, 30, 32Verified.....................................................14-15

Gold-platedBasket ..............................................16, 22-23Shaft.........................................................22-23

Graduated Cylinder ...................................119, 121

HHPLC (High Performance LiquidChromatography) .......................................106-107Hanger..........................................................112-113Hardness Tester.................................112-115, 127Harmonized/harmonization..................6, 50, 108Heater/Circulator ...6, 21, 48-49, 54, 60-61, 108Height Gauge .................................................43, 68Height Measurement ....................................66-67Height Spacer .................................................67-68High Performance Liquid Chromatography –

see HPLCHolder

Acrylic Rod..............................................55-56Angled Disk ............................................55-56Cuvette........................................................102Filter...............................................................35Intrinsic .........................................................47Reciprocating.........5, 42, 54-56, 62, 74, 125Sample.....................................................57-59Spring.......................................................54-56Stent ..................................................56, 58-59Transdermal ...........................................43, 55Weighted.................................................42-43

Hotline .................................................................137


Alphabetical Index

HPLC, Automated................................82, 106-107HPLC Injector ..........................62, 82-83, 107, 125HPLC Vial .................................................57, 71, 82Hydrogel...................................................................5

IIQ (Instrument Qualification) ..........3, 7, 123-126IVIVC (in vitro / in vivo correlation)......130, 132Immediate Release News................................136Implant ...................................................4, 5, 54, 60Infinity LC System......................................106-107Insert Cup..............................................................43In Situ..........................................................6, 84, 98Instrument Qualification – see IQInterchangeable Paddle/Basket Shaft......16-17,

.................................................................22, 26Intrinsic Dissolution Apparatus

Die........................................................5, 46-47Holder ......................................................46-47Punch.......................................................46-47Surface Plate..........................................46-47

In-vessel Temperature Measurement, AutoTemp .......................................6-7, 12, 34

In Vitro Dissolution of Ointments, Creams and Transdermals Seminar.......131

In vitro / in vivo correlation – see IVIVC

J/KJapanese Pharmacopeia (JP) ...........................33Japanese Sinker Basket ..............................33, 41Jaw Plate............................................112, 114-115

LLC (Liquid Chromatography) ....................106-107Labcast ................................................................134Large Volume Conversion Kit ......................30-32Liquid Chromatography – see LCLuer Lock Type Cannula .........................34-35, 54

MMCT (Multicell Transport)...................88, 92, 101MQ (Mechanical Qualification)...............3-4, 6-7,

......13, 16, 22, 27, 64-66, 122-123, 128, 134Manifold ...................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, 75Manuals, Qualification/Service ..............122-124Mechanical Calibration.......................................65Mechanical Qualification – see MQMedia Replacement .............57-58, 70-71, 74, 95Mega Paddle ..................................................22, 25Mesh..................................5, 16-17, 22-24, 33, 43,

........................53, 55-56, 59, 61, 72, 108-110

Microparticle...........................................................5Mini Basket .....................16-18, 23-24, 26, 30, 54Mini Paddle ............................5, 17, 18-19, 22, 26,

.........................................29-30, 32, 37, 44-45Modified Release ...................................................5Motorized Sampling Manifold ....................37, 71Multi-apparatus .............................................90, 93Multicell Transport (MCT)...................88, 92, 101

Multicell UV Dissolution System.......................7, .........................................................95-97, 126

Multicomponent Analysis............................85, 92Multiplexer .....................................84, 98, 101-103

NNeedle, Replacement..........................................75NIST-traceable .....................................................66

OOQ (Operational Qualification) .3, 7, 87, 124-127Offline UV Dissolution .......................................91, Ointment...................................................5, 44, 131Online UV Dissolution ..........8, 30, 84, 87, 94-95,

.................................................98-99, 102, 104Operational Qualification (OQ) ................3, 7, 87,

..............................................................124-127Ordering Information ................................139-140Osmotic Pump..................................................5, 54

PPC Control.......................................................54, 71PM (Preventive Maintenance) ................124-125PQ (Performance Qualification) .3, 123, 125-126PTV (Performance Testing Verification) ...........3,

.............................................................123, 126Paddle Over Disk Assembly .........................42-43Paddle

Dura-Tef .........................................................25ElectropolishedStainless Steel ..........................17, 22, 25-26Mega.......................................................22, 25Mini .................................5, 17, 18-19, 22, 26, .........................................29-30, 32, 37, 44-45PEEK........................17, 22, 25-26, 35, 59, 78Teflon-coated .......................16-17, 22, 25-26Verified ..............................................17, 25-26

Paddle Support Rack...........................................26Paper, Printer .................................................21, 65Pathlength ............................................98, 102-103Performance Qualification (PQ) – see PQPerformance Testing Verification (PVT) see PVTPeristaltic Pump.........7, 62, 70-77, 79-84, 89-90,

...................................................95-97, 99, 105Pharmaceutical .............2-4, 57, 108132-133, 136Pharmacopeia .................3-4, 6, 18-19, 29, 44, 82Physical Parameter .....6-7, 64, 67, 123, 128, 133Physical Testing ........................................123-124Plastic Disk .........................................................110Plastic Tubing .......................................................29Plastic Vessel .......................................................28Plunger Assembly..............................................110Powder......................................................5, 33, 119Preventive Maintenance (PM) ........................124Printer

Paper.......................................................21, 65Ribbon ...........................................................65Thermal...................................9-10, 14-15, 21

Probe ..........................................................................Fiber-optic................................20-21, 98, 102Temperature ....6, 11, 20-21, 34, 57, 64, 110Thermistor..............................................48, 60

Punch, Intrinsic ..............................................46-47

QQAII C Mechanical Qualification

Station ..........................................7, 13, 64-65QA/QC .....................................................................2Qualification Guide..............................27, 123-127Qualification Services ..............................122-123

RReciprocating Cylinder

300 mL Vessel................................................5Evaporation Cap ..........................................52Lower cap .....................................................52Upper cap .....................................................52

Reciprocating Disk .........................................54-56Reciprocating Holder – See HolderRelease Rate............................................44, 50, 60Replacement Screens ..................................43-53Resident Cannula Kit...........................................36Resident Probe .21, 34, 41, 72, 78, 94, 104-105Retrofit ............40, 51, 74, 111, 114-117, 119-120Return Cannulas....................8, 14, 20, 52, 77, 88Ribbon, Cartridge .................................................65Rinse Tray .......................................................21, 74Rod, Basket Suspension, ................................110Rotating Basket.5-9, 12-14, 16-18, 20-24, 26, 30Rotating Bottle Apparatus............................60-61

Bottle.............................................................61Clip .................................................................61Cap.................................................................61Decant ...........................................................61Liner...............................................................61Screen ...........................................................61

Rotating Cylinder .............................5-6, 42-43, 68Rotation ......................................................116, 118RPM Sensor (Speed)...........................................64RPM Sensor (Magnetic) ...............................64-65

SSample / Return Cannulas ........8, 14, 20, 52, 77Sample Collector..................................................82Sample Tube, Glass ............................................52Sampling ...................................................................

Automated....................6, 8-9, 13-15, 20, 34, .......................38, 51, 70, 72, 91, 94, 104-105Cannula....................9, 34, 36, 39, 71, 75-77, Manual ...............8, 14, 31, 34-36, 41, 71, 75Manifold ................11, 20-21, 31, 34, 37, 72, ......................................88-90, 95-97, 104-105Tray..............................................57, 71-72, 74

Scanning Spectrophotometer............................85Screen ................5, 42-43, 50, 53, 60-61, 109-110Seminar

Correlating Dissolution and Bioavailability: Understanding IVIVC ................................130Dissolution and Bioequivalence of Generic

Pharmaceuticals ................................................132Dissolution Method Development and Validation....................................................129Fundamentals of Dissolution .................128In Vitro Dissolution of Ointments, Creams and Transdermals.......................131

Septum-capped vials .....................................74-75


Alphabetical Index

Services ............................................3, 87, 122-137Shaft

Basket ............................5, 8-9, 13-14, 16-17, ..................................23-24, 26, 55-56, 68, 72Calibrated......................................................64Paddle ...............7-8, 13, 16-17, 21-22, 25-26

Shield, Fragment................................................113Shield, Safety......................................................114Single-drum Friability Tester ....................116-118Sinker...............................................................33, 41Sipper.........................................................82, 91-92Skin .............................................................5, 44, 54Small-volume.................................5, 18-19, 30, 57Software

Cary WinUV Dissolution..84-85, 99-103, 126ChemStation UV-visible ..87, 89, 92-93, 126Dissolution Workstation ....7, 51, 54, 57-58,..................................... 62-63, 71, 82-83, 185

Spacer ..................................31, 35, 60, 67-68, 108Spectrophotometer........................2, 7, 84-85, 87,

....................................................90-95, 98-105Spin On/Spin Off – see Two-piece

Interchangeable Paddle/Basket ShaftStainless Steel, Electropolished

Basket.....................................................17, 22Paddle.........................................17, 22, 25-26

Stent ......................................................5, 54, 56-59Suppository ..................................................24, 109Suppository Basket .............................................16Suspension

Cup ...........................................................42-43Rod...............................................................110

Sustained Release...........................................5, 50Syringe Pump ...38, 51, 54, 57, 62, 70-79, 83-84,

..................................96-97, 99, 104-105, 140Syringe.......................................................35, 78-79

TTablet ....4-5, 9, 50, 54, 60, 86, 112-116, 123, 127Tablet Fragment

Brush ...................................................112-113Shield...................................................112-113

Tablet Hardness Tester ...................112-115, 127Tachometer ..............................................64, 67, 69Tapped Density Tester ......................119-121, 127Technical Documentation ..............................7, 13Teflon Cell..............................................................44Teflon-coated

Basket ...............................................16, 22-24Paddle.........................................17, 22, 25-26Shaft.........................................................23-25

Teflon Tubing ........................................................81Terms and Conditions .......................................138Tester, Dissolution – See Dissolution ApparatusThermal Printer............................9-10, 14-15, 21, Thermistor .....................................................48, 60Thickness Gauge ......................................114-115Timepoint ........................6, 11, 34, 38, 54, 57, 59,

62, 70-71, 78-82, 84, 87, 89-90, 95-98, 107Tip

Filter .........................................................38-39Training .......................................122-123, 128-135Transdermal Patch Holder..................................43

TrayRinse .......................................................21, 74Sample ........................57, 59, 71-72, 74, 140

Trim Pot Tool ...............................................112-113TruAlign Vessel .......6-7, 9, 12, 19, 27, 29, 32, 45TruCenter Vessel ...............................27-28, 30, 32Tube

Disintegration Basket...............................109Glass ........................................................74-75Sample ..........................................................52

Tubing.........................................................................Adapter..........................................................48Clamp.......................................................48-49Color-coded ......................................20, 76-77Kit.................................................................101Peristaltic Pump..............................74-76, 81Plastic, PVC..................................................49Sample ..........................................................72Syringe Pump .........................................75-76Teflon .............................................................81

Two-piece Interchangeable Paddle/Basket Shaft ...............16-17, 22, 26

UUSP (United States Pharmacopeia)

<724> Drug Release...................................42<1087> Apparent Intrinsic Dissolution...46<1724> Pharmacopeial Forum Chapter .44Performance 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,...............57-58, 68-69, 72, 86, 108-110, 116, ............................119-123, 128, 131, 134-135

Upgrade........................20, 27, 60, 64-65, 101-102UV Dissolution..........................................................

Software................................................99-102System ....................7, 37, 78, 80, 87-94, 126

UV-visible Spectrophotometer .........7, 84-85, 87, .....................................91-93, 95, 98, 104-105

VValve .....................49, 70, 72-78, 85, 89-90, 92-94Valve Sampling ..............................................86, 92Verification Tool ............................7, 13, 35, 64-69Verified ...........8, 14, 16, 18, 22, 27, 109-110, 116Verticality...................................................................

Shaft.........................................................64-65Vessel................................................30, 64-65

Vessel1L........................19, 27-29, 35-36, 42, 44, 75100 mL............................18-19, 27-29, 31, 521000 mL – see 1L 200 mL.......18-19, 28-29, 31-32, 45, 92, 1042L..............9, 18-19, 28-29, 31-32, 69, 75, 93250 mL ............................................19, 29, 32300 mL .........................................................52500 mL ....................................................28, 36Amber .......................................15, 28-29, 140DVH TruAlign .................12-15, 18-19, 27-29EaseAlign ...............................................28, 30Glass ........................................12, 31, 93, 104Peak .......................................5, 19, 28-29, 69

Plastic ......................................................27-28TruAlign........................6-9, 11-12, 14, 18-19, ..............................................27, 29, 32, 40, 45TruCenter .......................27-28, 30-32, 36, 40Verified ...........................8, 14-16, 18, 22, 27, ...............................................62, 109-110, 116

VialGlass ........................................................74-75HPLC ........................................57, 71, 82, 140Septum-capped ......................................74-75

Viton Liner .......................................................60-61VanKel ......................................2, 7, 34, 84, 87, 92Varian ..................................2, 7, 34, 48, 84, 87, 92VK

VK 100 – see 100 Automated Disintegration ApparatusVK 200 – see 200 Tablet Hardness Tester ..VK 5010 – see 5010 Height/Center Qualification StationVK 7000/7010/7025/7030 – Discontinued,see 708-DS and 709-DS DissolutionApparatusVK 750D – see 750 Heater/CirculatorVK 806 – see 806 Syringe PumpVK 808 – see 808 Filter ChangerVK 8000 – see 8000 Dissolution Sampling StationVK 8020 – see 8020 DissolutionSampling/HPLC InjectorVK Verified – see Verified

WWarranty Information........................................139Water Bath ......................6, 12, 21, 30, 40, 48-49,

..................................57, 60-61, 64, 108, 110Wavelength............................................85, 98, 100Wedge.........................................................116, 118Weight Hanger ..........................................112-113Weighted Holder ............................................42-43Weight....................................33, 38-39, 42-43, 86,

.............................................112-113, 116, 121Wire............................................................33, 55-56Wobble Gauge..........................................64, 67-68Workstation Software................7, 51, 54, 57, 58,

............................................62-63, 71, 82, 125

X, Y, ZZymark ......................................................17, 27, 41

Easy Ordering Terms and Conditions

Delivery and DiscountsMany products and accessories in this catalog are shipped from stock, while others are builtupon receipt of your order.A shipping and handling fee will be added to your order unless the purchase is over $2000 US.Special shipping (i.e., overnight in the US) is available in most regions at an additional cost. Agilent is required to collect all state and local sales taxes unless the buyer's tax-exemptcertificate is on file with Agilent Technologies. Please be prepared to provide a copy if it is noton file, when placing your order.Please check with your Agilent Customer Service Representative, local Authorized Distributor,or the Agilent website for current prices, special offers, promotions and discounts whenplacing your order.

Satisfaction GuaranteedIf you are not satisfied with your Agilent product within the first 60 days, you may return your purchase in its original condition for a full refund or credit. A return policy statementis included in every Agilent shipment and posted under Product Information on the website.

In the US and Canada, please call for a Return Authorization form and return instructions at 1-800-227-9770. If your Agilent product was purchased from a distributor, please contactthe distributor.

Shipping DamagesIf items are damages in transit, please follow the instructions below:If a shipment is visibly damaged upon arrival, do not accept it until the person making thedelivery has endorsed the bill of lading with statement for the extent of the damage.If any damage is found after unpacking, retain all cartons and inner packaging andimmediately request an inspection from the carrier.Notify the Agilent Customer Contact Center at 1-800-227-9770 about the damaged shipmentso that we can make the appropriate sales adjustment and/or provide you with returninstructions (Sales order number, product number and quantity damaged will be needed).

Ordering Information

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Easy Ways To Order• Phone: 1-800-227-9770 (select option 1, then option 3) in the US and Canada –

Monday-Friday, 8 AM to 8 PM EST• Fax: 1-302-633-8953 in the US• Email: [email protected] in the US and Canada• Online: www.agilent.com/chem in the US and Canada

Payment Options• In the US, Visa, MasterCard, Discover and American Express are accepted with a minimum

order of $20 (not applicable in all countries).• Email [email protected] to make an electronic payment using the ACH/EFT (Automated

Clearing House/Electronic Funds Transfer) method.• Establish a charge account through your Agilent Customer Service Representative or your

local Agilent sales office. An account number will be assigned to you for charging yourpurchases. Payment terms are net 30 days from the invoice date. All orders are subject tocredit approval.

We will be happy to supply a price quote via phone, email or fax if you need it in writing.

WarrantiesAll Agilent Technologies products in this catalog are designed and manufactured to stringentstandards under the Agilent quality system registered to ISO 9001. At Agilent, we back everyinstrument with a one-year warranty and a money-back guarantee. The warranty period foraccessories is 90 days. If Agilent receives notice of defects during the warranty period, Agilent shall, at its option, either repair or replace products which prove to be defective. If Agilent is unable, within a reasonable time, to repair or replace any product to a conditionas warranted, the buyer shall be entitled to a refund of the purchase price upon return of the product to Agilent. The warranty period for each product begins on the day of shipment.

This warranty shall not apply to any defect, failure, or damage caused by improper use orimproper/inadequate maintenance or care. This warranty is exclusive and no other warranty,whether written or oral, is expressed or implied. Agilent specifically disclaims the impliedwarranties of merchantability and fitness for particular purposes. The remedies providedherein are the buyer's sole and exclusive remedies. In no event shall Agilent be liable fordirect, indirect, special, incidental, or consequential damages (including loss of profits)whether based on contract, tort, or any other legal theory.

Ordering an Agilent 708-DS or Agilent 709-DSDissolution Apparatus

Questions to consider when preparing to order your 708-DS or 709-DSDissolution 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 micronfiltration)?

• 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?


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Order Form


Agilent Technologies Order Form Agilent Technologies

Order Date Purchase Order or Credit Card Number & Expiration

Shipping Address

Part Number Description Comment Qty. Price Total Price

Billing Address

If No, please provide Certificate #

TaxableY or N?

Yes No

Name:

Title:

Phone:

Company:

Fax:

Email:

Subtotal:

For additional assistance, visit www.agilent.com/lifesciences/dissoconfigurator to use the Dissolution Products Configuration Tool.Phone: 1-800-227-9770 (select option 1, then option 3) in the US and Canada – Monday-Friday, 8 AM to 8 PM ESTFax: 1-302-633-8953 in the US · Email: [email protected] in the US and CanadaOnline: www.agilent.com/chem in the US and Canada

Tax:

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:

708-DS AIQ Services:

708-DS AIQ Guides:

8000 Sampling Station:

8000 Accessory Kit:

8000 AIQ Svcs.:

8000 AIQ Guides:

UV Dissolution Software:

UV Disso SW Accessory 1:



UV Disso AIQ Services:

UV Disso AIQ Guides:

Total:

Outside the U.S. and Canada, please contact your local Agilent office or Authorized Distributor when ordering.

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.

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 8000. Not required if services are ordered.

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.

*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.

152

Notes


Confidence means getting the right results the first time. Visibility of yourdissolution test is critical for getting results you can trust, and the Agilent709-DS Dissolution Apparatus provides an unobstructed view of thedissolution environment. With its bath-free, open-access design and the latest smart vesseltechnology, the Agilent 709-DS provides accurate temperature control andreduced preheating time for maximum efficiency, all in a safety-coated vessel.Learn about the Agilent 709-DS at www.agilent.com/lifesciences/709-DSand witness the consistency, reproducibility, and convenience it can bringto your dissolution analysis.

VISUALIZEDISSOLUTIONCAPABILITIES

© Agilent Technolgies Inc. 2011

For more information

Learn more:www.agilent.com/lifesciences/dissolution

Buy online:www.agilent.com/chem/store

Find an Agilent customer center in your country:www.agilent.com/chem/contactus

U.S. and [email protected]

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Asia [email protected]

© Agilent Technologies, Inc. 2011Printed in Germany, October 01, 20115990-8146EN

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