15. Aspects to Consider When Low-Level Active Pharmaceutical Ingredient/Drug Product Degradants have the Potential for Genotoxicity

  1. Andrew Teasdale
  1. Alan P. McKeown1 and
  2. Andrew Teasdale2

Published Online: 3 JAN 2011

DOI: 10.1002/9780470929377.ch15

Genotoxic Impurities

Genotoxic Impurities

How to Cite

McKeown, A. P. and Teasdale, A. (2011) Aspects to Consider When Low-Level Active Pharmaceutical Ingredient/Drug Product Degradants have the Potential for Genotoxicity, in Genotoxic Impurities (ed A. Teasdale), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470929377.ch15

Editor Information

  1. AstraZeneca, Leicester, United Kingdom

Author Information

  1. 1

    Pfizer, Kent, United Kingdom

  2. 2

    AstraZeneca, Leicester, United Kingdom

Publication History

  1. Published Online: 3 JAN 2011
  2. Published Print: 14 FEB 2011

ISBN Information

Print ISBN: 9780470499191

Online ISBN: 9780470929377

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Keywords:

  • aspects to consider when low-level active pharmaceutical ingredient/drug product degradants - potential for genotoxicity;
  • safety of impurities, in active pharmaceutical ingredients (APIs) and drug products (DPs) - concern for pharmaceutical scientists and pharmaceutical regulatory agencies;
  • approaches, for understanding low-level degradant formation

Summary

This chapter contains sections titled:

  • Introduction

  • Approaches to Understanding Low - Level Degradant Formation

  • Other Considerations

  • Case Study

  • Overall Conclusions

  • References