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Dissolution Systems Source Book - 2013 Edition

Dissolution Systems Source Book - 2013 Edition
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Dissolution Systems Source Book - 2013 Edition - 1

For more information Learn more: www.agilent.com/lifesciences/dissolution Buy online: www.agilent.com/chem/store Dissolution Testing and Analysis Find an Agilent customer center in your country: www.agilent.com/chem/contactus DISSOLUTION SYSTEMS SOURCE BOOK 2013 Edition Asia Pacic inquiry_lsca@agilent.com DISSOLUTION SYSTEMS SOURCE BOOK Europe info_agilent@agilent.com © Agilent Technologies, Inc. 2013 Published in Germany, October 01, 2013 5991-3085EN

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Dissolution Systems Source Book - 2013 Edition - 3

Market Solutions Market Solutions Agilent Solutions for the Pharmaceutical Industry About Agilent Agilent Technologies is the world’s premier measurement company. Through the company’s acquisition of Varian, Inc. in 2010, we expanded our already extensive product portfolio for the pharmaceutical industry. The former VanKel Technology Group, which Varian acquired in 2001, offered many instruments for testing and evaluating pharmaceutical dosage forms including dissolution, disintegration, friability, hardness and tapped density. These products and accessories are now fully integrated in the...

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Dissolution Systems Source Book - 2013 Edition - 4

Market Solutions Workflow Enhancements We strive to provide solutions for every type of dissolution user, from routine applications to early drug development. Our equipment is designed to be easy to use, flexible and modular in nature. As the workload increases, we offer greater degrees of automation, both in the dissolution test run and sample collection as well as the data analysis and reporting. Purchasing a dissolution system from Agilent ensures you have one vendor to turn to should you have questions or require assistance, so you have less downtime and better utilization of your...

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Dissolution Systems Source Book - 2013 Edition - 5

Market Solutions Agilent Technologies Quality Policy Agilent will earn customer loyalty by providing products, services and interactions of the highest quality and greatest value. To achieve this result, we will: More Than Great Products Quality equipment is just one component of your work. We believe education is critical to ensuring correct results. For this reason, we offer numerous educational programs geared to various functions within your company. See page 153 for more information. 1. Ensure that all of our products comply with applicable safety and regulatory requirements. 2. Ensure...

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Dissolution Systems Source Book - 2013 Edition - 6

Industry Information Industry Information Apparatus, Pharmacopeia and Regulatory Affairs Overview The design of dissolution apparatus is specified by the various pharmacopeias from around the world. In addition, both the FDA and ASTM have called for tighter mechanical specifications. The apparatus is routinely operated in facilities regulated by federal agencies, such as the US Food and Drug Administration, which require laboratories to operate under good manufacturing practices (GMPs). Agilent’s dissolution apparatus are developed to operate under GMP environments which require...

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Dissolution Systems Source Book - 2013 Edition - 7

Industry Information Applications and Testing Capabilities of Agilent Dissolution Apparatus Dissolution Apparatus Common Products Types Stirred Vessel Methods – The basket and paddle dissolution apparatus are the most commonly used throughout the world. These methods traditionally require the placement of individual dosage forms into 1L glass vessels containing a fixed volume of fluid referred to as dissolution medium. Agilent 708-DS and 709-DS Dissolution Apparatus for Rotating Basket (USP Apparatus 1) Shaft with attached mesh basket fabricated from 316 stainless steel; the dosage form is...

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Dissolution Systems Source Book - 2013 Edition - 8

Dissolution Apparatus and Accessories Apparatus 1, 2, 5, 6 and Intrinsic Agilent 708-DS Dissolution Apparatus The 708-DS Dissolution Apparatus was upgraded with many new enhancements, solidifying our commitment to provide an ideal platform for laboratories to standardize their dissolution testing. This instrument is designed to deliver consistent performance and results while conforming to current internationally harmonized pharmacopeial specifications for basket, paddle, rotating cylinder, paddle over disk and intrinsic dissolution tests. The instrument’s versatile dissolution platform can...

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Dissolution Systems Source Book - 2013 Edition - 9

Dissolution Apparatus and Accessories • Flexible sampling options: access to all vessels and clearance from the vessel plate ensures Hands-free evaporation cover suspension supports easy media addition. • Expanded method storage • Power saving function • Expanded user access levels • New graphical instructions for manual dosage introduction quick, simple manual sampling through the evaporation cover port. or the convenient manual sampling bracket. Alternatively, automate your sampling timepoints with the Autosampling feature, the hands-free manifold and the 8000 Dissolution Sampling...

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Dissolution Systems Source Book - 2013 Edition - 10

Dissolution Apparatus and Accessories Designed with Compliance in Mind The recessed head with unobstructed access on the 708-DS makes setting and verifying physical parameters easier than ever, which is especially critical for Mechanical Qualification. 21 CFR Part 11 Compliance Agilent's Dissolution Workstation Software provides control of up to four dissolution apparatus from one PC. This software can operate any Agilent dissolution apparatus and sampling systems, as well as systems from Varian and VanKel. See page 78 for more information about the Dissolution Workstation Software. Agilent...

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Dissolution Systems Source Book - 2013 Edition - 11

Dissolution Apparatus and Accessories Standard 708-DS Configuration Because the 708-DS is designed for configurability, you have the ability to select the exact options you need for your instrument. A standard 708-DS includes: Did You Know? When recording the physical parameters of the dissolution apparatus, during Mechanical Qualification, for example, it is important to measure parameters with the actual shafts and vessels used when performing the dissolution tests. Record the accessory serial numbers and position within the apparatus. Agilent's 708-DS and 709-DS do not require the use of...

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Dissolution Systems Source Book - 2013 Edition - 12

Dissolution Apparatus and Accessories 708-DS Dissolution Apparatus Bundles In order to simplify ordering, product numbers are available for the most common 708-DS configurations. Each bundle includes a 708-DS, 1-Liter TruAlign clear glass vessels, interchangeable paddle and basket shafts, and baskets. Options are available to further customize each apparatus giving you the flexibility to support your specific testing needs. Equip your 708-DS with DDM to simplify dropping your dosage form when using paddles. Other options to consider are AutoTemp, sampling manifold, verified components, and...

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