Update on Undertaking Extractable and Leachable Testing

Download or read book Update on Undertaking Extractable and Leachable Testing written by Andrew Feilden and published by Smithers Rapra. This book was released on 2011-03-31 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.