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400-DS Dissolution Apparatus Specification


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400-DS Dissolution Apparatus Specification - 1

Specification Sheet The 400-DS Dissolution Apparatus sets the performance standard for drug-release testing of medical devices. It is the first dissolution apparatus built specifically for smallvolume dissolution testing of combination drug products that meets all compendial requirements for USP Apparatus 7. The 400-DS software provides compliance with 21 CFR Part 11 guidelines and brings an unprecedented level of convenience, throughput and efficiency to your quality control and R&D operations. To provide greater convenience and save valuable laboratory bench space, the autosampler is integrated into the body of this small footprint dissolution apparatus. System Parameter Sample reciprocation Temperature control Media volume Sample timepoints Input voltage Media types per test 0.2% or better of volume in 24 hours Regulatory compliance Instrument was tested to: The EMC Directive (2004/108/EC) Machinery Directive 2006/42/EC EN 61326-1:2006 IEC61010-1:2001 CAN/CSA-C22.2 No. 61010-1-04 ANSI/UL 61010-1: 2004 Height Width Depth Weight

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400-DS Dissolution Apparatus Specification - 2

For more information Learn more Find an Agilent customer center in your country U.S. and Canada 1-800-227-9770 Europe Asia Pacific Product specifications and descriptions in this document are subject to change without notice. © Agilent Technologies, Inc., 2013 Printed in the USA, March 14, 2013 5991-2120EN

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