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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 .. 15 Hygroscopicity .. 15 Solid-state properties .. 16 Other characteristics.

with the various sizes of volumetric pipettes and volumetric flasks commonly used for these operations (taking the usual formula: square root of the sum of the squares of individual relative errors, to estimate the relative dilution error). Tables giving the optimal number and nature of dilution steps needed to achieve a given

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