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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 technique. This book will be of interest to Chemists and R&D managers.
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Dr Andrew Feilden gained a degree and D.Phil from York University. He joined the analytical science department at AstraZeneca in 1998, where he is now responsible for the extractable and leachable testing. He is a recognized expert in the field of extractables and leachables being a member of the IPAC-RS container closure group (International Pharmaceutical Aerosol Consortium on Regulation and Science) and the ELSIE group (Extractable and Leachable Safety Information Exchange).
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Book Description Smithers, 2011. hardcover. Condition: very good. No Jacket. Smithers, 2011. Slim hardback, no dustjacket. Sticker to back cover, unread copy in very good condition. book. Seller Inventory # PB-16281