technical guide 欧洲药典质量标准起草指南

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1、TechnicalGuidefortheElaborationofMonographsEuropeanPharmacopoeiaEuropeanDirectoratefortheQualityofMedicines4thEdition-2005©CouncilofEurope,67075StrasbourgCedex,France-2005AllrightsreservedMakingcopiesofthisfileforcommercialpurposesorpostingthisfileonawebsitethatisopentopublicconsultati

2、onisstrictlyprohibited.TECHNICALGUIDEFORTHEELABORATIONOFMONOGRAPHSth4Edition–2005CONTENTS1INTRODUCTION.........................................................................................................................................51.1PURPOSEOFTHEGUIDE........................

3、....................................................................................................51.2TESTPROCEDURES....................................................................................................................................51.3EQUIPMENT.....................

4、..........................................................................................................................61.4QUANTITIES..............................................................................................................................................61.5RE

5、AGENTS................................................................................................................................................81.6COMMERCIALNAMES...................................................................................................................

6、.............91.7REFERENCESTANDARDS...........................................................................................................................92MONOGRAPHONASUBSTANCEFORPHARMACEUTICALUSE.................................................92.1DEFINITION....................

7、.........................................................................................................................102.1.1Combinations.................................................................................................................................112.1.2Content.

8、............