Cover image for Update on Undertaking Extractable and Leachable Testing.
Update on Undertaking Extractable and Leachable Testing.
Title:
Update on Undertaking Extractable and Leachable Testing.
Author:
Feilden, Andrew.
ISBN:
9781847354563
Personal Author:
Edition:
1st ed.
Physical Description:
1 online resource (180 pages)
Contents:
Front Cover -- Title Page -- Preface -- Contents -- Chapter 1 Introduction -- Chapter 2 Extraction Techniques -- Chapter 3 Liquid Extraction Techniques -- Chapter 4 General Analysis -- Chapter 5 Gas Chromatography -- Chapter 6 High-performance Liquid Chromatography -- Chapter 7 Inductively Coupled Plasma Metal Analysis -- Chapter 8 Conclusion -- Abbreviations -- Index -- Back Cover.
Abstract:
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.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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