Technical Guide For The Elaboration Of Monographs
Technical guide for theELABORATION OFMONOGRAPHSENGwww.edqm.euThe Council of Europe is the continent’s leading human rightsorganisation. It comprises 47 member states, 28 of which are membersof the European Union. The European Directorate for the Quality ofMedicines & HealthCare (EDQM) is a directorate of the Council of Europe.Its mission is to contribute to the basic human right of access to goodquality medicines and healthcare and to promote and protect publichealth.European PharmacopoeiaEDQM7th Edition2015
Technical guide for theELABORATION OF MONOGRAPHSEuropean Pharmacopoeia7th Edition2015European Directorate for the Quality of Medicines & HealthCare
English version2015Making copies of this file for commercialpurposes or posting it on a websitefor which access is charged is strictlyprohibited. Re-use of the file, in wholeor in part, requires that the sourcebe clearly cited and the EDQM(publications.info@edqm.eu)be informed.European Directorate for the Qualityof Medicines & HealthCare (EDQM)Council of Europe7, allée KastnerCS 30026F-67081 STRASBOURGFRANCECover image: EDQM - Council of EuropeDirector of the Publication: Dr S. KeitelPage layout: EDQMwww.edqm.eu Council of Europe, 2015
TECHNICAL GUIDE FOR THEELABORATION OF MONOGRAPHS7th Edition – 2015TABLE OF CONTENTSI.INTRODUCTION . 1I.1.I.2.I.3.I.4.I.5.I.6.I.7.II.PURPOSE OF THE GUIDE . 1TEST PROCEDURES . 1EQUIPMENT . 2QUANTITIES . 2REAGENTS . 4COMMERCIAL NAMES . 4REFERENCE STANDARDS . 4MONOGRAPH ON A SUBSTANCE FOR PHARMACEUTICAL USE. 5II.1.TITLE. 5II.2.DEFINITION . 6II.2.1.Combinations. 7II.2.2.Content . 7II.3.CHARACTERS . 8II.3.1.Appearance . 8II.3.2.Taste . 9II.3.3.Odour . 9II.3.4.Solubility . 9II.3.5.Stability factors . 10II.3.6.Hygroscopicity . 10II.3.7.Solid-state properties . 10II.3.8.Other characteristics . 10II.3.9.Behaviour in solution. 11II.4.IDENTIFICATION . 11II.4.1.General . 11II.4.2.Second Identification series . 12II.4.3.Infrared absorption spectrophotometry . 13II.4.4.Ultraviolet and visible absorption spectrophotometry . 13II.4.5.Melting point, freezing point and boiling point. 14II.4.6.Specific optical rotation . 15II.4.7.Thin-layer chromatography . 15II.4.8.Gas chromatography and liquid chromatography . 16II.4.9.Chemical reactions . 16II.5.TESTS . 16II.5.1.General . 16II.5.2.Title of tests . 17II.5.3.Solution S . 18II.5.4.Appearance of solution . 19II.5.4.1. Clarity and degree of opalescence (2.2.1.) . 19II.5.4.2. Degree of coloration (2.2.2.). 19II.5.5.II.5.6.pH and Acidity or alkalinity. 20Optical rotation (2.2.7.) . 21
II.5.7.II.5.8.Absorption spectrophotometry (ultraviolet and visible) (2.2.25.) . 22Related substances . 23II.5.8.1. Thin-layer chromatography (TLC) (2.2.27.). 27II.5.8.2. Liquid chromatography (LC) (2.2.29.) . 28II.5.8.3. Gas-liquid chromatography (GC) (2.2.28.). 33II.5.8.4. Capillary electrophoresis (CE) (2.2.31.) . 33II.5.9.Readily carbonisable substances . 34II.5.10. Foreign anions and/or cations . 35II.5.11. Heavy metals – Elemental Impurities . 35II.5.12. Loss on drying (2.2.32.) . 36II.5.13. Thermogravimetry (2.2.34.) . 36II.5.14. Semi-micro determination of water (2.5.12.) – (volumetric Karl Fischer) . 37II.5.15. Micro determination of water (2.5.32.) – (coulometric Karl Fischer) . 37II.5.16. Gas chromatographic determination of water . 37II.5.17. Determination of water by distillation (2.2.13.). 38II.5.18. Sulfated ash (2.4.14.) . 38II.5.19. Residue on evaporation . 38II.5.20. Residual solvents (2.4.24.) . 38II.5.21. Bacterial endotoxins . 38II.6.ASSAY. 39II.6.1.Ultraviolet and visible spectrophotometry (2.2.25.) . 40II.6.1.1. Direct measurement . 40II.6.1.2. Measurement after a colour reaction. 40II.6.2.Volumetric analysis. 40II.6.3.Chromatography. 41II.6.4.Determination of nitrogen by sulfuric acid digestion (2.5.9.). 41II.7.STORAGE . 41II.8.LABELLING . 42II.9.IMPURITIES . 42II.10. FUNCTIONALITY-RELATED CHARACTERISTICS . 43III.ANALYTICAL VALIDATION . 44III.1. DEFINITIONS AND TERMINOLOGY . 44III.1.1.Introduction . 44III.1.2.Types of analytical procedures to be validated. 44III.1.3.Validation characteristics and requirements . 45III.1.4.Glossary. 46III.2. METHODOLOGY . 47III.2.1.Introduction . 47III.2.2.Specificity . 48III.2.2.1. Identification . 48III.2.2.2. Assays and impurity tests . 49III.2.3.III.2.4.III.2.5.Linearity . 49Range . 50Accuracy . 51III.2.5.1. Assay . 51III.2.5.2. Impurities (quantification). 51III.2.5.3. Recommended data . 51III.2.6.Precision . 51III.2.6.1. Repeatability . 52III.2.6.2. Intermediate precision . 52III.2.6.3. Reproducibility. 52III.2.6.4. Recommended data . 52III.2.7.Detection limit . 52III.2.7.1. Based on visual evaluation . 52III.2.7.2. Based on signal-to-noise ratio . 52III.2.7.3. Based on the standard deviation of the response and the slope . 53III.2.7.4. Recommended data . 53III.2.8.Quantitation limit. 53III.2.8.1. Based on visual evaluation . 53III.2.8.2. Based on signal-to-noise ratio . 53III.2.8.3. Based on the standard deviation of the response and the slope . 54
III.2.8.4. Recommended data . 54III.2.9.Robustness . 54III.2.10. System suitability testing . 55III.3. SPECIFIC APPLICATION TO METHODS USED IN THE PH. EUR. . 55III.3.1.Optical rotation (2.2.7.) . 55III.3.1.1. Introduction . 55III.3.1.2. Identification . 55III.3.1.3. Tests . 55III.3.2.Ultraviolet spectrophotometry (2.2.25.). 56III.3.2.1. Identification . 56III.3.2.2. Limit test . 56III.3.2.3. Assay . 56III.3.3.Non-instrumental limit tests .
This document is a guide for the authors of monographs and also a means of communicating the principles for the elaboration of monographs to the users of the European Pharmacopoeia (Ph. Eur.), especially industry, licensing
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