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- Publication Date:Aug 2013
- Reference:Regulatory Toxicology and Pharmacology, 2013, 66(3), pp326-335
- Publication Type:Paper
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Potentially mutagenic impurities: Analysis of structural classes and carcinogenic potencies of chemical intermediates in pharmaceutical syntheses supports alternative methods to the default TTC...
Potentially mutagenic impurities in new pharmaceuticals are controlled to levels with negligible risk, the TTC (threshold of toxicological concern, 1.5 µg/day for a lifetime). The TTC was based on the more potent rodent carcinogens, excluding the highly potent “cohort of concern” (COC; for mutagenic carcinogens these are N-nitroso, Aflatoxin-like, and azoxy structures). We compared molecules with DEREK “structural alerts” for mutagenicity used in drug syntheses with the mutagenic carcinogens in the Gold Carcinogenicity Potency Database.