1. Guideline on the Limits of Genotoxic Impurities,CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006;Committee for Medicinal Products (CHMP), European Medicines Agency (EMEA):London, UK, 28 June 2006
2. Question & Answers on the CHMP Guideline on the Limits of Genotoxic Impurities,CPMP/SWP/5199/02, EMEA/CHMP/QWP/251344/2006;European Medicines Agency (EMEA):London, UK, 26 June 2008.
3. Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER):Silver Spring, MD, U.S.A., December 2008; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079235.pdf
4. Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet
5. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity