Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry
Author :
Publisher : John Wiley & Sons
Total Pages : 402
Release :
ISBN-10 : 9780470922972
ISBN-13 : 0470922974
Rating : 4/5 (72 Downloads)

Book Synopsis Characterization of Impurities and Degradants Using Mass Spectrometry by : Guodong Chen

Download or read book Characterization of Impurities and Degradants Using Mass Spectrometry written by Guodong Chen and published by John Wiley & Sons. This book was released on 2011-04-27 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.


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The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product lev