1. Regulation of genotoxic and carcinogenic impurities in drug substances and products;McGovern;TrAC: Trends Anal. Chem.,2006
2. A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity;Müller;Regul. Toxicol. Pharmacol.,2006
3. Guidance for Industry. Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches;US Food and Drug Administration, Department of Health and Human Services, Center for Drug Evaluation and Research (CDER),2008
4. European Medicines Evaluation Agency, Committee for Medicinal Products for Human Use, Guideline on the Limits of Genotoxic Impurities, CPMP/SWP/5199/02, London, 28 June 2006.
5. Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective;Raman;J. Pharmaceut. Biomed.,2011