2. LC Method Development and Strategies

  1. Birendra N. Pramanik3,
  2. Mike S. Lee4 and
  3. Guodong Chen5
  1. Gang Xue1 and
  2. Yining Zhao2

Published Online: 12 JUL 2011

DOI: 10.1002/9780470921371.ch2

Characterization of Impurities and Degradants Using Mass Spectrometry

Characterization of Impurities and Degradants Using Mass Spectrometry

How to Cite

Xue, G. and Zhao, Y. (2011) LC Method Development and Strategies, 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.ch2

Editor Information

  1. 3

    Merck and Co., Kenilworth, NJ, USA

  2. 4

    Milestone Development Services, Newtown, PA, USA

  3. 5

    Bristol-Myers Squibb Company, Princeton, NJ, USA

Author Information

  1. 1

    Pfizer Global R&D, Eastern Point Road, Groton, CT 06340, USA

  2. 2

    Pfizer Global R&D, 50 Pequot Avenue, New London, CT 06320, 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:

  • LC method development and strategies, accurate assessment of impurity profiles - of active pharmaceutical ingredients (APIs) in pharmaceutical analysis;
  • gradient and temperature optimization - “tweaked” to fine-tune resolution, reducing runtime;
  • high-efficiency separation, and UHPLC (ultra-high-performance liquid chromatography) instruments - and very high-efficiency separation within a short analysis time

Summary

This chapter contains sections titled:

  • Introduction

  • Column, pH, and Solvent Screening

  • Gradient and Temperature Optimization

  • Orthogonal Screening

  • High-Efficiency Separation

  • Conclusions

  • References