Control of impurities of pharmacopoeial substances - Scientific guideline

This document aims to facilitate compliance with the European Pharmacopoeia requirements set out in general monograph 'Substance for pharmaceutical use' and general chapter 'Control of impurities in substances for pharmaceutical use'. It provides guidance to applicants who are encountered with so called old monographs during marketing authorisation process.

Keywords: Active substance, impurities, pharmacopoeial substances, European Pharmacopoeia, monograph, certificate of suitability (CEP)

Current effective version

Guideline on control of impurities of pharmacopoeial substances: compliance with the european pharmacopoeia general monograph "substances for pharmaceutical use" and general chapter "control of impurities in substance...

AdoptedReference Number: CPMP/QWP/1529/04Legal effective date: 01/04/2004