2024年3月14日发(作者：)

USP32-NF27

General Notices 凡 例

2

Introduction 简介..........................................................................................................2

4. MONOGRAPHS AND GENERAL CHAPTERS 正文和附录.............................3

5. MONOGRAPH COMPONENTS 专论构成............................................................7

6. TESTING PRACTICES AND PROCEDURES 试验规范和过程....................18

7. TEST RESULTS 测试结果..................................................................................28

8. TERMS AND DEFINITIONS 术语及定义.........................................................31

9. PRESCRIBING AND DISPENSING 开方和配方..............................................41

10. PRESERVATION, PACKAGING, STORAGE, AND LABELING防腐，包装，贮

藏和标签......................................................................................................................42

66

Introduction 简介....................................................................................................66

TITLE 标题..............................................................................................................67

“OFFICIAL” AND “OFFICIAL ARTICLES” “药典的”和“药典药物”....................68

STORAGE UNDER NONSPECIFIC CONDITIONS 非特定条件下的贮存..........70

OTHER GENERAL NOTICES 其他凡例.................................................................71

USP32

Introduction 简介

GENERAL NOTICES AND REQUIREMENTS

凡例和要求

Change to read:

The General Notices and Requirements section (the General Notices) presents the basic

assumptions, definitions, and default conditions for the interpretation and application of the United

States Pharmacopeia (USP) and the National Formulary (NF).

凡例和要求部分（凡例）给出对USP和NF中假设、定义、默认条件的解释和应用。

Requirements stated in these General Notices apply to all articles recognized in the USP and NF

(the “compendia”) and to all general chapters unless specifically stated otherwise. Where the

requirements of an individual monograph differ from the General Notices or a general chapter, the

monograph requirements apply and supersede the requirements of the General Notices or the

general chapter, whether or not the monograph explicitly states the difference.

除另有规定外，凡例中的要求应用于所有USP和NF公认的(即药典的)药品，也适用于所有

附录。如果专论的要求与凡例或附录要求不同，无论专论是否说明改差别，都应使用专论要

求取代凡例或附录的要求。