7. Practical Application of Very High-Pressure Liquid Chromatography across the Pharmaceutical Development–Manufacturing Continuum

  1. Birendra N. Pramanik2,
  2. Mike S. Lee3 and
  3. Guodong Chen4
  1. Brent Kleintop and
  2. Qinggang Wang

Published Online: 12 JUL 2011

DOI: 10.1002/9780470921371.ch7

Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry

How to Cite

Kleintop, B. and Wang, Q. (2011) Practical Application of Very High-Pressure Liquid Chromatography across the Pharmaceutical Development–Manufacturing Continuum, 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.ch7

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. Bristol-Myers Squibb, Analytical Research and Development, New Brunswick, NJ 08903, 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:

  • practical application of very High-performance liquid chromatography (VHPLC) across pharmaceutical development–manufacturing continuum - faster analyses, not compromising on chromatographic efficiency;
  • VHPLC, natural extension of HPLC - having same chromatographic theory and principles;
  • VHPLC method validation, in pharmaceutical development - for GMP/GLP testing, health authority guidelines

Summary

This chapter contains sections titled:

  • Introduction

  • Theory and Benefits of VHPLC

  • VHPLC Method Development

  • Other Practical Considerations

  • VHPLC Method Validation

  • Summary

  • References