Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry

Editor(s): Birendra N. Pramanik, Mike S. Lee, Guodong Chen

Published Online: 12 JUL 2011 12:45PM EST

Print ISBN: 9780470386187

Online ISBN: 9780470921371

DOI: 10.1002/9780470921371

Series Editor(s): Mike S. Lee

About this Book

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.

Table of contents

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  1. Part I: Methodology

    1. Chapter 1

      Introduction to Mass Spectrometry (pages 1–57)

      Scott A. Smith, Ruth Waddell Smith, Yu Xia and Zheng Ouyang

  2. Part II: Application

    1. Chapter 8

      Impurity Identification for Drug Substances (pages 231–250)

      David W. Berberich, Tao Jiang, Joseph McClurg, Frank Moser and R. Randy Wilhelm

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