ICH Q3B (R2) Impurities in new drug products - Scientific guideline
HumanScientific guidelines
Portuguese is available via eTranslation, the European Commission's machine translation service.
Translate to Portuguese | Important information about machine translation
This document provides guidance on the content and qualification of impurities in new drug products for registration applications. It applies to drug products produced from chemically synthesised new drug substances not previously registered in a region or Member State.
Keywords: Finished product, impurities, reporting, control, qualification, specifications