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Acceptable Intakes (AIs) for 11 Simple N-Nitrosamine (NA) Impurities

Glowienke, Susanne (2023) Acceptable Intakes (AIs) for 11 Simple N-Nitrosamine (NA) Impurities. Regulatory toxicology and pharmacology.


Low levels of N-nitrosamine (NA) impurities were detected in pharmaceuticals and, as a result, health authorities (HAs) have developed acceptable intakes (AI) as a protective control on the level of NA permissible in pharmaceuticals. Eleven common NA impurities were analyzed in a comprehensive and transparent toxicological process consistent with ICH M7 and compared to the AIs developed by HAs. This comprehensive analysis included substances which had datasets which were robust, limited but sufficient, and substances with insufficient carcinogenicity data. In the case of robust or limited but sufficient carcinogenicity information, AIs were calculated based on published or derived TD50’s from the most sensitive organ site. In the case of insufficient carcinogenicity information, available carcinogenicity data and structure activity relationship (SAR) was used and applied to existing thresholds of 1500 ng/day, 150 ng/day or 18 ng/day. This approach advances the methodology used to derive AIs for NA impurities.

Item Type: Article
Date Deposited: 01 Sep 2023 00:45
Last Modified: 01 Sep 2023 00:45