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  • Publisher:
    Elsevier
  • Publication Date:
    Aug 2013
  • Reference:
    Regulatory Toxicology and Pharmacology, 2013, 66(3), pp326-335
  • DOI:
    10.1016/j.yrtph.2013.05.005
  • PMID:
  • Publication Type:
    Paper
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  • Scientific Area:
  • Endpoint:
    Mutagenicity
  • Industry Type:
    Pharmaceutical
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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...

Bercu JP; Galloway S; Gealy R; McGettigan K; Reddy MV;

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.

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