Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
10.3870/j.issn.1004-0781.2025.11.003
- VernacularTitle:2025年版《中华人民共和国药典》金属药包材标准制订路径和收载逻辑解析
- Author:
Fangfang ZHANG
1
;
Rong CAI
;
Wanling LAN
;
Lei CHEN
;
Lin YAO
;
Hao DING
;
Weiyi LU
;
Yaju ZHOU
;
Fenglan ZHANG
;
Yuan LIU
;
Kai XU
;
Liang CHANG
;
Yan LIU
;
Feifei JIA
;
Ying LI
;
Yan JIANG
;
Dandan WANG
;
Shengli WU
;
Yong SHEN
;
Xiangwei XU
;
Yanggege LYU
Author Information
1. 上海市食品药品包装材料测试所,上海 201203
- Publication Type:Journal Article
- Keywords:
The pharmacopeia of the People's Republic of China;
Metallic pharmaceutical packaging;
Standard interpretation
- From:
Herald of Medicine
2025;44(11):1745-1751
- CountryChina
- Language:Chinese
-
Abstract:
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
