technical - guide - for - the - elaboration - of - monographs - 7th - edition - 20151 - 图文

ELABORATION OF MONOGRAPHSTechnical guide for the European PharmacopoeiaEDQM7th Edition2015 ELABORATION OF MONOGRAPHS

Technical guide for the

European Pharmacopoeia7th Edition

2015

European Directorate for the Quality of Medicines & HealthCare

English version

2015

Making copies of this file for commercial

purposes or posting it on a website for which access is charged is strictly prohibited. Re-use of the file, in whole

or in part, requires that the source

be clearly cited and the EDQM (publications.info@edqm.eu)

be informed.

European Directorate for the Quality of Medicines & HealthCare (EDQM)

Council of Europe 7, allée Kastner

CS 30026

F-67081 STRASBOURG

FRANCE Cover image: ? EDQM - Council of Europe Director of the Publication: Dr S. Keitel

Page layout: EDQM

www.edqm.eu

? Council of Europe, 2015

TECHNICAL GUIDE FOR THE ELABORATION OF MONOGRAPHS

7th Edition – 2015

TABLE OF CONTENTS

I. I.1. I.2. I.3. I.4. I.5. I.6. I.7. II.

INTRODUCTION ............................................................................................................................................... 1 PURPOSE OF THE GUIDE .............................................................................................................................. 1 TEST PROCEDURES ...................................................................................................................................... 1 EQUIPMENT .................................................................................................................................................... 2 QUANTITIES ................................................................................................................................................... 2 REAGENTS ...................................................................................................................................................... 4 COMMERCIAL NAMES ................................................................................................................................. 4 REFERENCE STANDARDS ........................................................................................................................... 4 MONOGRAPH ON A SUBSTANCE FOR PHARMACEUTICAL USE ........................................................ 5

II.1. TITLE ................................................................................................................................................................ 5 II.2. DEFINITION .................................................................................................................................................... 6 II.2.1. Combinations ............................................................................................................................................ 7 II.2.2. Content ..................................................................................................................................................... 7 II.3. CHARACTERS ................................................................................................................................................ 8 II.3.1. Appearance ............................................................................................................................................... 8 II.3.2. Taste ......................................................................................................................................................... 9 II.3.3. Odour ....................................................................................................................................................... 9 II.3.4. Solubility ................................................................................................................................................... 9 II.3.5. Stability factors ....................................................................................................................................... 10 II.3.6. Hygroscopicity ........................................................................................................................................ 10 II.3.7. Solid-state properties .............................................................................................................................. 10 II.3.8. Other characteristics .............................................................................................................................. 10 II.3.9. Behaviour in solution .............................................................................................................................. 11 II.4. IDENTIFICATION ......................................................................................................................................... 11 II.4.1. General ................................................................................................................................................... 11 II.4.2. Second Identification series .................................................................................................................... 12 II.4.3. Infrared absorption spectrophotometry .................................................................................................. 13 II.4.4. Ultraviolet and visible absorption spectrophotometry ............................................................................ 13 II.4.5. Melting point, freezing point and boiling point ....................................................................................... 14 II.4.6. Specific optical rotation .......................................................................................................................... 15 II.4.7. Thin-layer chromatography .................................................................................................................... 15 II.4.8. Gas chromatography and liquid chromatography .................................................................................. 16 II.4.9. Chemical reactions ................................................................................................................................. 16 II.5. TESTS ............................................................................................................................................................. 16 II.5.1. General ................................................................................................................................................... 16 II.5.2. Title of tests ............................................................................................................................................ 17 II.5.3. Solution S ................................................................................................................................................ 18 II.5.4. Appearance of solution ........................................................................................................................... 19

II.5.4.1. Clarity and degree of opalescence (2.2.1.) ................................................................................................................. 19 II.5.4.2. Degree of coloration (2.2.2.) ...................................................................................................................................... 19

II.5.5. II.5.6. pH and Acidity or alkalinity .................................................................................................................... 20 Optical rotation (2.2.7.) .......................................................................................................................... 21