YE Qian, WANG Qi, YU Min, WANG Xue, GENG Xingchao, ZHANG Leshuai, WEN Hairuo. Study on the mutagenic risk of nitrosamine compounds[J]. Chinese Journal of Pharmacovigilance, 2022, 19(8): 881-888.
[1] CHAROO NA, ALI AA, BUHA SK, et al.Lesson learnt from recall of valsartan and other angiotensin II receptor blocker drugs containing NDMA and NDEA impurities[J]. AAPS Pharm Sci Tech, 2019, 20(5): 166. [2] US Food and Drug Administration. Search list of recalled angiotensin II receptor blockers (ARBs) including valsartan, losartan and irbesartan: find out which specific blood pressure medications are affected by the recall [EB/OL]. (2019-11-12) [2022-04-10]. https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-angiotensin-ii-receptor -blockers-arbs-including-valsartan-losartan-and. [3] LEE HS.Literature compilation of volatile N-nitrosamines in processed meat and poultry products - an update[J]. Food Addit Contam Part A Chem Anal Control Expo Risk Assess, 2019, 36(10): 1491-1500. [4] European Medicines Agency. ICH guideline M7(R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk step 5[EB/OL].(2018-03-02)[2022-04-10]. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m7r1-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit_en.pdf. [5] European Medicines Agency. Question & Answers on the CHMP Guideline on the limits of genotoxic impurities[EB/OL].(2010-09-23)[2022-04-10]. https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-guideline-limits- genotoxic-impurities_en.pdf. [6] WEN HR, WANG YN, YANG Y, et al.Mutagenic risk evaluation of monanthone with emodin type[J]. Chinese Journal of Pharmacovigilance, 2020, 17(8): 455-460. [7] YE Q, WANG Q, WEN HR.Effect of different metabolic activation conditions on the results of bacterial reverse mutation test of N-nitrosamine compounds[J]. Chin Med Biotechnol, 2022, 17(2): 118-124. [8] MAGEE PN, BARNES JM.The production of malignant primary hepatic tumors in the rat by feeding dimethylnitrosamine[J]. Br J Cancer, 1956, 10(1): 114-122. [9] GUSHGARI AJ, HALDEN RU.Critical review of major sources of human exposure to N-nitrosamines[J]. Chemosphere, 2018, 210: 1124-1136. [10] CROSS KP, PONTING DJ.Developing structure-activity relationships for N-nitrosamine activity[J]. Comput Toxicol, 2021, 20: 100-186. [11] POTTEGARD A, KRISTENSEN KB, ERNST MT, et al.Use of N-nitrosodimethylamine (NDMA) contaminated Valsartan products and risk of cancer: danish nationwide cohort study[J]. BMJ (Clinical research ed.), 2018, 362: 3851. [12] WAGNER ED, HSU KM, LAGUNAS A, et al.Comparative genotoxicity of nitrosamine drinking water disinfection byproducts in Salmonella and mammalian cells[J]. Mutat Res, 2012, 741(1-2): 109-115.