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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.

6 TECHNICAL GUIDE FOR THE ELABORATION OF MONOGRAPHS 1. INTRODUCTION 1.1. PURPOSE OF THE GUIDE This document is a guidance for …

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