Technical Guide - EDQM
Technical Guidefor the elaboration of monographsEuropean PharmacopoeiaEuropean Directorate for the Quality of Medicines & HealthCare6th Edition - 2011
Council of Europe, 67075 Strasbourg Cedex, France - 2011All rights reservedMaking copies of this file for commercial purposes or posting this file on a web sitethat is open to public consultation is strictly prohibited.
3TECHNICAL GUIDE FOR THE ELABORATION OF MONOGRAPHS6th Edition – 2011CONTENTS1. INTRODUCTION .61.1.1.2.1.3.1.4.1.5.1.6.1.7.PURPOSE OF THE GUIDE .6TEST PROCEDURES .6EQUIPMENT.7QUANTITIES .7REAGENTS .9COMMERCIAL NAMES .9REFERENCE STANDARDS . 102. MONOGRAPH ON A SUBSTANCE FOR PHARMACEUTICAL USE . 102.1.DEFINITION . 112.1.1. Combinations . 122.1.2. Content . 122.2.CHARACTERS . 142.2.1. Appearance . 142.2.2. Taste . 152.2.3. Odour . 152.2.4. Solubility . 152.2.5. Stability factors . 152.2.6. Hygroscopicity . 152.2.7. Solid-state properties . 162.2.8. Other characteristics . 162.2.9. Behaviour in solution . 162.3.IDENTIFICATION . 172.3.1. General . 172.3.1.1. Methods requiring complex instrumentation .182.3.1.2. Other methods .182.3.2.Infrared absorption spectrophotometry . 182.3.2.1. Salts of organic acids or bases .182.3.2.2. Chemically related substances .182.3.2.3. Polymorphism .192.3.2.4. Optical isomers .192.3.3.2.3.4.2.3.5.2.3.6.2.3.7.2.3.8.Ultraviolet and visible absorption spectrophotometry . 19Melting point, freezing point and boiling point . 20Specific optical rotation . 21Thin-layer chromatography . 21Gas chromatography and liquid chromatography . 21Chemical reactions . 222.4.TESTS. 222.4.1. General . 222.4.2. Titles. 222.4.3. Solution S . 232.4.4. Appearance of solution. 242.4.4.1. Clarity and degree of opalescence .24
42.4.4.2. Degree of coloration .252.4.5.2.4.6.2.4.7.2.4.8.pH and Acidity or alkalinity . 25Optical rotation. 27Absorption spectrophotometry (ultraviolet and visible) . 27Related substances. 282.4.8.1. Thin-layer chromatography (TLC) .322.4.8.2. Liquid chromatography (LC) .332.4.8.3. Gas-liquid chromatography (GC) .372.4.8.4. Capillary electrophoresis (CE) .2.4.16.2.4.17.2.4.18.2.4.19.2.4.20.Readily carbonisable substances . 39Foreign anions and/or cations . 39Heavy metals . 40Loss on drying . 41Thermogravimetry (2.2.34) . 42Semi-micro determination of water (Karl Fischer – 2.5.12). 42Micro determination of water (2.5.32) . 42Gas chromatographic determination of water . 43Determination of water by distillation (2.2.13) . 43Sulfated ash (2.4.14). 43Residue on evaporation . 43Residual solvents . 432.5.ASSAY . 442.5.1. Ultraviolet and visible spectrophotometry . 442.5.1.1. Direct measurement .442.5.1.2. Measurement after a colour reaction .452.5.2.2.5.3.2.5.4.2.6.2.7.2.8.2.9.Volumetric analysis . 45Chromatography . 46Determination of nitrogen by sulfuric acid digestion (semi-micro method) . 46STORAGE . 46LABELLING . 47IMPURITIES . 47FUNCTIONALITY-RELATED CHARACTERISTICS . 473. ANALYTICAL VALIDATION . 483.1.DEFINITIONS AND TERMINOLOGY . 483.1.1. Introduction . 483.1.2. Types of analytical procedures to be validated . 483.1.3. Validation characteristics and requirements . 493.1.4. Glossary. 503.2.METHODOLOGY . 523.2.1. Introduction . 523.2.2. Specificity . 533.2.2.1. Identification .533.2.2.2. Assays and impurity tests .533.2.3.3.2.4.3.2.5.Linearity . 54Range . 54Accuracy . 553.2.5.1. Assay .55
53.2.5.2. Impurities (quantification) .563.2.5.3. Recommended data .563.2.6.Precision . 563.2.6.1. Repeatability .563.2.6.2. Intermediate precision.563.2.6.3. Reproducibility .563.2.6.4. Recommended data .573.2.7.Detection limit . 573.2.7.1. Based on visual evaluation .573.2.7.2. Based on signal-to-noise ratio .573.2.7.3. Based on the standard deviation of the response and the slope .573.2.7.4. Recommended data .583.2.8.Quantitation limit . 583.2.8.1. Based on visual evaluation .583.2.8.2. Based on signal-to-noise ratio .583.2.8.3. Based on the standard deviation of the response and the slope .583.2.8.4. Recommended data .593.2.9. Robustness. 593.2.10. System suitability testing . 593.3.SPECIFIC APPLICATION TO METHODS USED IN THE PHARMACOPOEIA . 603.3.1. Optical rotation (2.2.7) . 603.3.1.1. Introduction.603.3.1.2. Identification .603.3.1.3. Tests .603.3.1.4. Assay .613.3.2.Ultraviolet spectrophotometry (2.2.25) . 613.3.2.1. Identification .613.3.2.2. Limit test.613.3.2.3. Assay .613.3.3.Non-instrumental limit tests . 613.3.3.1. Appearance of solution (2.2.1 and 2.2.2) .613.3.3.2. Acidity or alkalinity .623.3.3.3. Limit tests for anions/cations (2.4) .623.3.4.Atomic absorption spectrometry (2.2.23) . 633.3.4.1. Specificity .633.3.4.2. Calibration .633.3.4.3. Matrix effects.643.3.4.4. Detection and quantification limit (based on the standard deviation of the blank) .643.3.5.Separation techniques .
This document is a guidance for the authors of monographs and also a means of communicating to the users of the European Pharmacopoeia, especially industry, licensing authorities and official medicines control laboratories, the principles for the elaboration of monographs. Since the principles applied and guidance given for the elaboration of monographs should be the same as those applied by .
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