六、参考文献1.ICH M7(R1) Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals of limit potential carcinogenic risk [EB/OL] (2017-03-31)2.世界卫生组织国际癌症研究机构致癌物清单,http://samr.cfda.gov.cn/WS01/CL1991/215896.html3.(a) Assessment report, 14 February 2019, EMA/217823/2019. (b)A Screening Procedure for the Formation of Nitroso Derivatives and Mutagens by Drug-Nitrite Interaction, Chem. Pharm. Bull. 1982, 30(9), 3399-3404. (c) Formation of N-Nitrosodimethylamine (NDMA) from Dimethylamine during Chlorination, Environ. Sci. Technol. 2002, 36, 588-595. (d) N-nitrosomethylanlaniline, Org. Synth. 1933, 13, 82. (e)Nitrosomethylurea.Org. Synth. 1935, 15, 48.4.(a) Information on nitrosamines for marketing authorisation holders,EMA/189634/2019. (b) Questions and answers on “Information on nitrosamines for marketing authorisation holders”,EMA/CHMP/428592/2019 Rev.15.ICH Q9 Quality risk management [EB/OL] (2005-11-09)6.Inhibition of Nitrosamine Formation by Inorganic and Organic Salts, Chem Pharm Bull, 1986, 34(8), 3485-3487.7.Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac),https://www.fda.gov/drugs/drug-safety-and-availability/8.Statementfrom Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation andResearch, on impurities found in diabetes drugs outside the U.S. https://www.fda.gov/news-events/press-announcements/statement-janet-woodcock-md-director-fdas-center-drug-evaluation-and-research-impurities-found9.(a) Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities, 17 April 2019, EMA/248364/2019 Rev 1. (b) Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines, 20 August 2019, EMA/351053/2019 rev 1. (c) FDA updates table of interim limits for nitrosamine impurities in ARBs, http://www.fda.gov/Drugs/DrugSafety/ucm613916.htm 点击免费获取微信申请试用 30 天