1. (a) Nitrosamine Impurities in Human Medicinal Products, EMA/369136/2020, European Medicines Agency, June 25, 2020. (b) Questions and Answers for Marketing Authorisation Holders/Applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on Nitrosamine Impurities in Human Medicinal Products, European Medicines Agency, February 26, 2021.
2. ICH Guideline M7(R1) on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, EMA/CHMP/ICH/83812/2013; European Medicines Agency, August 25, 2015.
3. FDA Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs, September 2020.
4. (a) Cheung, P. C. W. "A Historical Review of the Benefits and Hypothetical Risks of Disinfecting 310 Drinking Water by Chlorination" J. Ecology. Environ. 2017, 8, 2157-6092. (b) Yang, C. S.
5. Hong, J. "Cytochrome P450IIe1: Roles in Nitrosamine Metabolism and Mechanisms of Regulation", Drug Metabolism Reviews, 1990, 22, 147-159.