10. Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development

  1. Birendra N. Pramanik2,
  2. Mike S. Lee3 and
  3. Guodong Chen4
  1. Changkang Pan,
  2. Frances Liu and
  3. Michael Motto

Published Online: 12 JUL 2011

DOI: 10.1002/9780470921371.ch10

Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry

How to Cite

Pan, C., Liu, F. and Motto, M. (2011) Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development, in Characterization of Impurities and Degradants Using Mass Spectrometry (eds B. N. Pramanik, M. S. Lee and G. Chen), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470921371.ch10

Editor Information

  1. 2

    Merck and Co., Kenilworth, NJ, USA

  2. 3

    Milestone Development Services, Newtown, PA, USA

  3. 4

    Bristol-Myers Squibb Company, Princeton, NJ, USA

Author Information

  1. Pharmaceutical and Analytical Development, Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA

Publication History

  1. Published Online: 12 JUL 2011
  2. Published Print: 16 MAY 2011

Book Series:

  1. Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications, and Methods

Book Series Editors:

  1. Mike S. Lee

Series Editor Information

  1. Milestone Development Services, Newtown, PA, USA

ISBN Information

Print ISBN: 9780470386187

Online ISBN: 9780470921371

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Keywords:

  • structure elucidation of pharmaceutical impurities and degradants - in drug formulation, pharmaceutical impurity, component that is not the chemical identity;
  • strategy for structure elucidation of unknowns - new LC-MS method, when original LC method being not MS-compatible;
  • hyphenated analytical techniques, in drug development - chromatographic separation coupled online with information-rich detectors

Summary

This chapter contains sections titled:

  • Importance of Drug Degradation Studies in Drug Development

  • Drug Degradation Studies in Formulation Development

  • Complexity of Impurity Identification in Drug Development

  • Strategy for Structure Elucidation of Unknowns

  • Hyphenated Analytical Techniques Used in Drug Development

  • Case Studies

  • Acknowledgment

  • References