10. Analysis of Genotoxic Impurities: Review of Approaches

  1. Andrew Teasdale
  1. Dave Elder

Published Online: 3 JAN 2011

DOI: 10.1002/9780470929377.ch10

Genotoxic Impurities

Genotoxic Impurities

How to Cite

Elder, D. (2011) Analysis of Genotoxic Impurities: Review of Approaches, in Genotoxic Impurities (ed A. Teasdale), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470929377.ch10

Editor Information

  1. 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



  • analysis of genotoxic impurities - review of approaches;
  • HPLC, a key separation technique - for analytes that are insufficiently volatile, and/or too thermally labile for reliable GC analysis;
  • aromatic amines, and phenylamines, aminopyridines - and other heterocyclic amines, forming a broad class of potential GIs


This chapter contains sections titled:

  • Introduction

  • Sulfonate Esters

  • Alkyl Halides and Chloroformates

  • Epoxides and Hydroperoxides

  • Hydrazines and Hydrazides

  • N - Nitroso

  • Aromatic Amines

  • Aldehydes

  • Technology Transfer

  • General Discussion

  • Acknowledgments

  • References