Characterization of Impurities and Degradants Using Mass Spectrometry

Copyright © 2011 John Wiley & Sons, Inc.

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

Product Information

About The Product

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

    1. You have free access to this content
      Frontmatter (pages i–xxii)

  2. 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. Chapter 2

      LC Method Development and Strategies (pages 59–79)

      Gang Xue and Yining Zhao

    3. Chapter 3

      Rapid Analysis of Drug-Related Substances Using Desorption Electrospray Ionization and Direct Analysis in Real Time Ionization Mass Spectrometry (pages 81–108)

      Hao Chen and Jiwen Li

    4. Chapter 4

      Orbitrap High-Resolution Applications (pages 109–134)

      Robert J. Strife

    5. Chapter 5

      Structural Characterization of Impurities and Degradation Products in Pharmaceuticals Using High-Resolution LC-MS and Online Hydrogen/Deuterium Exchange Mass Spectrometry (pages 135–181)

      Guodong Chen and Birendra N. Pramanik

    6. Chapter 6

      Isotope Patten Recognition on Molecular Formula Determination for Structural Identification of Impurities (pages 183–211)

      Ming Gu

  3. Part II: Application

    1. Chapter 7

      Practical Application of Very High-Pressure Liquid Chromatography across the Pharmaceutical Development–Manufacturing Continuum (pages 213–229)

      Brent Kleintop and Qinggang Wang

    2. Chapter 8

      Impurity Identification for Drug Substances (pages 231–250)

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

    3. Chapter 9

      Impurity Identification in Process Chemistry by Mass Spectrometry (pages 251–277)

      David Q. Liu, Mingjiang Sun and Lianming Wu

    4. Chapter 10

      Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development (pages 279–335)

      Changkang Pan, Frances Liu and Michael Motto

    5. Chapter 11

      Investigation of Degradation Products and Extractables in Developing Topical OTC (Over the Counter) and NCE (New Chemical Entity) Consumer Healthcare Medication Products (pages 337–390)

      Fa Zhang

    6. Chapter 12

      Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry (pages 391–426)

      Li Tao, Michael Ackerman, Wei Wu, Peiran Liu and Reb Russell

    7. Chapter 13

      Identification and Quantification of Degradants and Impurities in Antibodies (pages 427–459)

      David M. Hambly and Himanshu S. Gadgil

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      Index (pages 461–462)

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