Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use” - Scientific guideline

This document aims to facilitate the compliance with European Pharmacopoeia with respect to the control of impurities of pharmacopoeial substances.

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

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 substances for pharmaceutical use”

Adopted Reference Number: EMA/CVMP/QWP/907965/2022 Legal effective date: 17/02/2023

Document history

Position paper 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 substan...

Adopted Reference Number: EMEA/CVMP/059/04 -FINAL Legal effective date: 01/03/2004