ICH Q3A (R2) Impurities in new drug substances

Table of contents

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

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