This document provides guidance on the content and qualification of impurities in new drug substances for registration applications. It applies to drug substances produced by chemical syntheses and not previously registered in a region or Member State. It covers chemistry and safety aspects of impurities in new drug substances.

Keywords: Drug substance, impurities, organic, inorganic, solvents, reporting, control, qualification, specifications

Current effective version

ICH: Q 3 A (R2): Impurities in new drug substances - Step 5

AdoptedLegal effective date: Reference Number: CPMP/ICH/2737/99

English (EN) (63.42 KB - PDF)

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