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Search results with tag "Impurities in pharmaceutical"
Guideline on assessment and control of DNA reactive ...
www.ema.europa.euof DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk which was used as a template, with amendments introduced in order to cover the issues specific to VM Ps. 2. Scope of guideline This document is intended to provide guidance for new veterinary drug substances and new VMPs,
A C DNA R (M P L P C R M7(R1) - ICH
database.ich.org1 ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK M7(R1) 1. INTRODUCTION The synthesis of drug substances involves the use of reactive chemicals, reagents, solvents, catalysts, and other processing aids.