Quantitative genotoxicity assessment of N-nitrosodimethylamine in mice by error-corrected next-generation sequencing and DNA methylation quantification for toxicity threshold determination.

Abstract excerpt

The contamination of N-nitrosamines (N-NAs) in pharmaceuticals has raised global concerns, due to potential carcinogenic risks. N-nitrosodimethylamine (NDMA) is a rodent carcinogen and the most prevalent N-NAs impurity in drug products. Current acceptable intake of NDMA (96 ng/day) is a simple linear extrapolation from rodent carcinogenicity data, which may not comprehensively characterize its genotoxic potential...

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