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Update on Undertaking Extractable and Leachable Testing von Feilden, Andrew (eBook)

  • Erscheinungsdatum: 31.03.2011
  • Verlag: Smithers Information Limited
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Update on Undertaking Extractable and Leachable Testing

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.


    Format: PDF
    Kopierschutz: AdobeDRM
    Erscheinungsdatum: 31.03.2011
    Sprache: Englisch
    ISBN: 9781847354563
    Verlag: Smithers Information Limited
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