Wow! eBook
Update on Undertaking Extractable and Leachable Testing
Author(s): Andrew Feilden (Author)
- Publisher: Rapra Technology Ltd
- Publication Date: 31 Mar. 2011
- Language: English
- Print length: 180 pages
- ISBN-10: 1847354556
- ISBN-13: 9781847354556
Book Description
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.
