Update on undertaking extractable and leachable testing

Update on undertaking extractable and leachable testing

by Feilden, Andrew

Type Book
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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 …

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Title Statements

  • Full title :Update on undertaking extractable and leachable testing / Andrew Feilden

Summary

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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Edition Statements

  • Publication Date:2011, ©2010

Publication Statements

  • Publisher(s):ISmithers
  • Place of Publication:Shrewsbury [England]
  • Language:eng
  • Publication Date:2011, ©2010

The Physical Object

  • Description:Online-Ressource (x, 168 Seiten) : Illustrationen

Edition Identifiers

  • ISBN:9781847354556, 1847354556
  • oclc:ocn839014456
  • LC Classification:TP156.E8
  • Dewey Decimal:628/.36

Table of 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;.

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