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 Feiden.

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."--Publisher.

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Edition Statements

  • Publication Date:2011.

Publication Statements

  • Publisher(s):ISmithers Rapra Pub
  • Place of Publication:Shrewsbury
  • Language:eng
  • Publication Date:2011.

The Physical Object

  • Description:1 online resource (x, 168 pages) : : illustrations

Edition Identifiers

  • ISBN:9781847354563, 1847354564, 1847354556, 9781847354556, 1613442831, 9781613442838, 1283123525, 9781283123525
  • oclc:ocn729167100
  • LC Classification:TD795.7
  • Dewey Decimal:628/.36

Table of 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.

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