Control and analysis of hydrazine, hydrazides and hydrazones--genotoxic impurities in active pharmaceutical ingredients (APIs) and drug products

J Pharm Biomed Anal. 2011 Apr 5;54(5):900-10. doi: 10.1016/j.jpba.2010.11.007. Epub 2010 Nov 13.


This is the latest of a series of reviews focused on the analysis of genotoxic impurities. This review summarises the analytical approaches reported in the literature relating to hydrazine, hydrazines, hydrazides and hydrazones. It is intended to provide guidance for analysts needing to develop procedures to control such impurities, particularly where this is due to concerns relating to their potential genotoxicity. Of particular note is the wide variety of techniques employed, both chromatographic and spectroscopic, with most involving derivatisation. Such a wide variety of options allow the analyst a real choice in terms of selecting the most appropriate technique specific to their requirements. Several generic methodologies, covering the three main analytical approaches; i.e. HPLC (high performance liquid chromatography), GC (gas chromatography) and IC (ion chromatography), are also described.

Publication types

  • Review

MeSH terms

  • Chemistry Techniques, Analytical / instrumentation
  • Chemistry Techniques, Analytical / methods*
  • Drug Contamination*
  • Hydrazines / analysis*
  • Hydrazones / analysis
  • Mutagens / analysis*
  • Pharmaceutical Preparations / analysis*
  • Pharmaceutical Preparations / chemistry


  • Hydrazines
  • Hydrazones
  • Mutagens
  • Pharmaceutical Preparations
  • hydrazine