欧洲药典凡例中英对照表

章节 (Section)

英文原文 (Official English Text)

中文参考翻译 (Reference Chinese Translation)

1.

GENERAL NOTICES

凡例

1.1.

General Statements

概述

Applicability

适用性

Official texts

法定文本

‘Unless otherwise prescribed or justified and authorised’

“除非另有规定或经过论证并获得批准”

General monographs

通用各论

Monograph titles

各论标题

Relative atomic and molecular masses

相对原子质量和分子量

Temperature

温度

Quantities

计量

Expression of content

含量表示

Potency

效价

Production

生产

Excipients

辅料

Definition

定义

Equivalence of final scaled-up formula to batch size for which validation data are available

最终放大生产处方与已获验证数据的批量的等同性

1.2.

Other Provisions Applying to the General Chapters and Monographs

适用于通则和各论的其他规定

Reagents and solutions

试剂与溶液

Solvents

溶剂

Expression of concentrations

浓度表示法

Water

水

Titrations

滴定

Indicators

指示剂

Chromatography

色谱法

Identification

鉴别

Tests and assays

检查与含量测定

Calculation

计算

Limits

限度

Indication of compliance with a monograph

符合各论的标示

Reference standards

对照品

Herbal drugs

草药

1.3.

General Chapters

通则

1.4.

Monographs

各论

Title

标题

CAS registry number

CAS注册号

Definition

定义

Production

生产

Characters

性状

Identification

鉴别

Tests

检查

Assay

含量测定

Functionality-related characteristics

功能性相关特性

Storage

贮藏

Labelling

标签

Warnings

警示语

Impurities

杂质

Scope

范围

1.5.

Abbreviations and Symbols

缩写与符号

A

A (Absorbance) / A (Relative atomic mass)

A Ph. Eur. reagent

A Ph. Eur. reagent (European Pharmacopoeia reagent)

ATCC

American Type Culture Collection

bp

Boiling point

BRP

Biological Reference Preparation

CRS

Chemical Reference Substance

d²⁰₄

Relative density

IU

International Unit

M

Molarity

Mr

Relative molecular mass

ppm

Parts per million

R

Substance or solution described under Reagents

R-d

Relative retardation

RV

Reference value

1.6.

Units of the International System (SI) Used in the Pharmacopoeia and Equivalence with Other Units

药典中使用的国际单位制(SI)单位及其与其他单位的换算关系