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Update on Undertaking Extractable and Leachable Testing by Andrew Feilden
English | 2011 | ISBN-10: 1847354556 | PDF | 180 pages | 2,3 MB
The assessment of all materials - and especially elastomeric and plastic components - for the presence of leachable and extractable components, forms an important part of the submission for approval of a new drug system or medical device.

This Update gives a detailed, state-of-the-art review of the selection of techniques, available to the analyst, to perform a controlled extraction study for leachables and extractables, with an overview of the factors to consider when selecting the extraction technique. This book will be of interest to Chemists and R&D managers.

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