Update on Undertaking Extractable and Leachable Testing
Feilden, Andrew
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.
หมวดหมู่:
ปี:
2011
ฉบับพิมพ์ครั้งที่:
1
สำนักพิมพ์:
iSmithers Rapra Publishing
ภาษา:
english
จำนวนหน้า:
274
ISBN 10:
1847354564
ISBN 13:
9781847354563
ไฟล์:
PDF, 2.33 MB
IPFS:
,
english, 2011