Transcription of Technical Guide - EDQM
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Technical Guide - EDQM
Technical Guidefor the elaboration of monographs European PharmacopoeiaEuropean Directorate for the Quality of Medicines & HealthCare 6th Edition - 2011 Council of Europe, 67075 Strasbourg Cedex, France - 2011 All rights reservedMaking copies of this fi le for commercial purposes or posting this fi le on a web site that is open to public consultation is strictly Technical Guide FOR THE ELABORATION OF MONOGRAPHS 6th Edition 2011 CONTENTS 1. INTRODUCTION .. 6 PURPOSE OF THE Guide .. 6 TEST PROCEDURES .. 6 EQUIPMENT .. 7 QUANTITIES .. 7 REAGENTS .. 9 COMMERCIAL NAMES .. 9 REFERENCE STANDARDS .. 10 2. MONOGRAPH ON A SUBSTANCE FOR PHARMACEUTICAL USE .. 10 DEFINITION .. 11 Combinations .. 12 Content .. 12 CHARACTERS .. 14 Appearance .. 14 Taste .. 15 Odour .. 15 Solubility .. 15 Stability factors.
may also serve as a guideline in the elaboration of specifications intended for inclusion in licensing applications. It is necessary to bear in mind that a monograph will be a mandatory standard and must be applicable in licensing procedures in all Member States of the Convention on the Elaboration of a European Pharmacopoeia.
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