Control of impurities of pharmacopoeial substances

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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)

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