VICH GL10 Impurities in new veterinary drug substances - Scientific guideline

This document provides guidance for registration applications on the content and qualification of impurities in new drug substances intended to be used for new veterinary medicinal products. It applies to the substances produced by chemical syntheses and not previously registered in a region or member state.

Keywords: Drug substance, impurities, organic, inorganic, solvents, specifications, VICH, veterinary medicial product (VMP)


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