5. Compound-Specific Risk Assessments for Genotoxic Impurities: Examples and Issues

  1. Andrew Teasdale
  1. Andrew Teasdale2 and
  2. Charles Humfrey1

Published Online: 3 JAN 2011

DOI: 10.1002/9780470929377.ch5

Genotoxic Impurities

Genotoxic Impurities

How to Cite

Teasdale, A. and Humfrey, C. (2011) Compound-Specific Risk Assessments for Genotoxic Impurities: Examples and Issues, in Genotoxic Impurities (ed A. Teasdale), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470929377.ch5

Editor Information

  1. AstraZeneca, Leicester, United Kingdom

Author Information

  1. 1

    AstraZeneca, Alderley Park, 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:

  • compound-specific risk assessments - for genotoxic impurities, and issues;
  • aniline, widespread use in dye industry - limited use in drug syntheses;
  • alkyl halides, in synthetic chemistry - incorporating alkyl groups into a molecule

Summary

This chapter contains sections titled:

  • Introduction

  • Evaluation Process

  • Aniline (CAS NO. 62-53-3)

  • Comparison of Permitted Daily Exposures (PDE) Limits Described in International Conference on Harmonisation (ICH) Q3C Guideline and Quantitative Cancer Risk Estimates

  • Overall Conclusions

  • Appendix

  • References