1. ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk European Directorate for the Quality of Medicines and Healthcare. EMA/CHMP/ICH/83812/2013.
2. ICH Q3A: Impurities in New drug substances (R2) October2006.
3. Enquiry: alkyl mesilate (methane sulfonate) impurities in Mesilate salts;European Directorate for the Quality of Medicines and Healthcare;PharmEuropa,2000
4. Committee for Proprietary Medicinal Products Position paper on the limits of Genotoxic Impurities London 18th December2002 CPMP/SWP/5199/02/draft 2.
5. Committee for Medicinal Products for Human Use (CHMP) Guidelines on the Limits of Genotoxic Impurities London 23rd June2004. CPMP/SWP/5199/02.