1. Committee for Medicinal Products for Human Use (CHMP) 2006 Guideline on the Limits of Genotoxic Impurities
2. US Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry 2008 Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches
3. CHMP Safety Working Party 2009 Questions and Answers on the CHMP Guideline on the limits of Genotoxic Impurities
4. ICH Topic S2A 1995 Genotoxicity: Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva
5. ICH Topic S2B 1997 Genotoxicity: A standard battery for genotoxicity testing of pharmaceuticals International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva