Control of impurities of pharmacopoeial substances
Table of contents
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.
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... (PDF/149.67 KB)Adopted
First published: 22/04/2004
Last updated: 22/04/2004
Legal effective date: 01/04/2004