ICH Q3A (R2) Impurities in new drug substances - Scientific guideline

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

Adopted Reference Number: CPMP/ICH/2737/99 Legal effective date: 01/08/2002