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药徒
发表于 2021-5-15 15:38:33 | 显示全部楼层 |阅读模式

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欧洲药典中的general chapters\ general notice\general text\general monographs都分别是啥意思?
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大师
发表于 2021-5-15 16:25:13 | 显示全部楼层
那正文都不用看了
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药仙
发表于 2021-5-15 19:50:48 | 显示全部楼层
general chapters 类似于通用技术要求
\ general notice  类似于凡例
\general text   类似于制剂通则
\general monographs  类似以具体的通用技术要求

Contents of the General Notices
Part I
Italic introduction

European Pharmacopoeia

Part II
Italic introduction

Official Standards

Definition of Terms

Expression of Standards

Temperature

Weights and Measures

Atomic Weights

Constant Weight

Expression of Concentrations

Water Bath

Reagents

Indicators

Caution Statements

Titles

Chemical Formulae

Definition

Production

Manufacture of Formulated Preparations

Freshly and Recently Prepared

Methods of Sterilisation

Water

Excipients

Colouring Agents

Antimicrobial Preservatives

Characteristics

Solubility
Identification

Reference Spectra
Assays and Tests

Biological Assays and Tests

Reference Substances and Reference Preparations

Chemical Reference Substances
Biological Reference Preparations
Storage

Labelling

Action and Use

Crude Drugs; Traditional Herbal and Complementary Medicines

Monograph Title
Definition
Characteristics
Control Methods
Homoeopathic Medicines

Unlicensed Medicines

Part III
Italic introduction

General Notices of the European Pharmacopoeia

1.1 General Statements
Quality Systems
Alternative Methods
Demonstration of Compliance with the Pharmacopoeia
Grade of Materials
General Monographs
Validation of Pharmacopoeial Methods
Implementation of Pharmacopoeial Methods
Conventional Terms
Interchangeable Methods
References to Regulatory Documents
1.2 Other Provisions Applying to General Chapters and Monographs
Quantities
Apparatus and Procedures
Water-bath
Drying and Ignition to Constant Mass
Reagents
Solvents
Expression of Content
Temperature
1.3 General Chapters
Containers
1.4 Monographs
Titles
Relative Atomic and Molecular Masses
Chemical Abstracts Service (CAS) Registry Number
Definition
Limits of Content
Herbal Drugs
Production
Choice of Vaccine Strain, Choice of Vaccine Composition
Potential Adulteration
Characters
Solubility
Identification
Scope
First and Second Identifications
Powdered Herbal Drugs
Tests and Assays
Scope
Calculation
Limits
Indication of Permitted Limit of Impurities
Herbal Drugs
Equivalents
Culture Media
Storage
Labelling
Warnings
Impurities
Functionality-related Characteristics of Excipients
Reference Standards
1.5 Abbreviations and Symbols
Abbreviations used in the Monographs on Immunoglobulins, Immunosera and Vaccines
Collections of Micro-organisms
1.6 Units of the International System (SI) used in the Pharmacopoeia and Equivalence with other Units
International System of Units (SI)
Notes
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药仙
发表于 2021-5-15 19:53:41 | 显示全部楼层
2.png 1.png 3.png
压缩包比较清晰

index.rar

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