1. ICH M7 Step 2 February 2013 - Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
2. Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
3. 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, 28 June 2006
4. International Conference on Harmonisation (ICH). Guideline Q3A (R2): Impurities in New Drug Substances; October 2006.
5. A Tool for the Semiquantitative Assessment of Potentially Genotoxic Impurity (PGI) Carryover into API Using Physicochemical Parameters and Process Conditions