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GUIDANCE DOCUMENT

M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk March 2018

Final
Docket Number:
FDA-2018-D-0740
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids. As a result of chemical synthesis or subsequent degradation, impurities reside in all drug substances and associated drug products. While ICH Q3A Impurities in New Drug Substances (Revision 2) (Q3A) and Q3B(R2) Impurities in New Drug Products (Q3B) (Refs. 1 and 2) provide guidance for qualification and control for the majority of the impurities, limited guidance is provided for those impurities that are DNA reactive.


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All written comments should be identified with this document's docket number: FDA-2018-D-0740.