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1 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 2 ICH Q3A: Impurities in New drug substances (R2), October 2006.

3 3 European Directorate for the Quality of Medicines and Healthcare (2000). Enquiry: alkyl mesilate (methane sulfonate) impurities in Mesilate salts. PharmEuropa 12: 27.

4 4 Committee for Proprietary Medicinal Products, Position paper on the limits of Genotoxic Impurities, London 18th December 2002, CPMP/SWP/5199/02/draft 2.

5 5 Committee for Medicinal Products for Human Use (CHMP), Guidelines on the Limits of Genotoxic Impurities, London 23rd June 2004. CPMP/SWP/5199/02.

6 6 ICH Q3C Residual Solvents (R6), October 2016.

7 7 Snodin, D.J. and McCrossen, S. (2013). Mutagenic impurities in pharmaceuticals: a critique of the derivation of the cancer TTC (threshold of toxicological concern) and recommendations for structural‐class‐based limits. Regul Toxicol Pharmacol 67: 299–316.

8 8 Muller, L., Mauthe, R.J., Riley, C.M. et al. (2006). Regulatory Toxicology and Pharmacology 44: 198–211.

9 9 Committee for Medicinal Products for Human Use (CHMP), Guidelines on the Limits of Genotoxic Impurities, London 26th June 2006. CPMP/SWP/5199/02.

10 10 CHMP SAFETY WORKING PARTY (SWP), Question & Answers on the CHMP Guideline on the Limits of Genotoxic Impurities. London, 17 December 2009. EMEA/CHMP/QWP/251344/2006Q&A.

11 11 Elder, D.P. and Teasdale, A. (2015). Is avoidance of genotoxic intermediates/impurities tenable for complex, multistep syntheses? Organic Process Research and Development. 19: 1437–1144.

12 12 Bercu, J.P., Hoffman, W.P., Lee, C.y., and Ness, D.K. (2008). Reg Toxicology and Pharmacology 51 (3): 270–277.

13 13 CHMP Scientific article 5(3) Opinion on the potential risks of carcinogens, mutagens and substances toxic to reproduction when these substances are used as excipients of medicinal products for human use. London, 18 October 2007. EMEA/CHMP/SWP/146166/2007.

14 14 GRAS List: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/default.htmExcipients

15 15 Teasdale, A., Elder, D.P., and Snodin, D. (2010). Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals. Journal of Pharmaceutical and Biomedical Analysis 51: 1015–1023.

16 16 EDQM (2008). Potentially genotoxic impurities and European pharmacopoeia monographs on substances for human use. PharmEuropa 20 (3): 426–427.

17 17 Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches Draft, Center for Drug Evaluation and Research (CDER) December 2008.

18 18 Concept Paper on the Development of a Guideline on the Assessment of Genotoxic Constituents in Herbal Substances/Preparations, Committee for Medicinal Products (CHMP), European Medicines Agency, London, 25 October 2006. (EMEA/HPPC/413271/2006).

19 19 ICH Topic S9 Non‐clinical Evaluation for Anticancer Pharmaceuticals, Step 3, EMEA/CHMP/ICH/646107/2008.

20 20 ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals ‐ questions and answers. EMA/CHMP/ICH/453684/2016