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    Mar 2013
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    Regulatory Toxicology and Pharmacology, 2013, 65(2), pp201-213
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    • Carcinogenicity
    • Mutagenicity
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Determination of compound-specific acceptable daily intakes for 11 mutagenic carcinogens used in pharmaceutical synthesis

Dobo KL; Ellis P; Kenyon MO;

The synthesis of pharmaceutical products often involves the use of reactive starting materials and intermediates. Low levels may be present in the final product as impurities and of particular concern are impurities that have mutagenic and carcinogenic potential. Regulatory guidance documents provide a general framework to minimise human exposure to these impurities; however, compound-specific recommendations are limited. Our practical experience with 11 pharmaceutical impurities is presented. 

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