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Mutagenicity and genotoxicity evaluation of 15 nitrosamine drug substance-related impurities in human TK6 cells.

Regulatory toxicology and pharmacology : RTP - 1 Dec 2024

Li Xilin, Le Yuan, Guo Xiaoqing, King Sruthi T, Dorsam Robert T, Atrakchi Aisar H, McGovern Timothy J, Davis-Bruno Karen L, Keire David A, Heflich Robert H, Mei Nan

Abstract excerpt

Nitrosamine drug substance-related impurities (NDSRIs) are a sub-category of N-nitrosamine drug impurities that share structural similarity to the corresponding active pharmaceutical ingredient. The mutagenicity of NDSRIs is poorly understood. We previously tested a series of NDSRIs using the Enhanced Ames Test (EAT). In this follow-up study, we further examined the genotoxicity and mutagenicity of 15 of these...

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PMID: 39433234
DOI: 10.1016/j.yrtph.2024.105730

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