Quality Control and Application Analysis of Metallic Materials and Containers for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
10.3870/j.issn.1004-0781.2025.11.005
- VernacularTitle:2025年版《中华人民共和国药典》药品包装用金属材料和容器质量控制与应用分析
- Author:
Hao DING
1
;
Fangfang ZHANG
;
Lei CHEN
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 Pharmacopoeia of the People's Republic of China;
Pharmaceutical packaging;
Matallic materials;
Quality control;
Compatibility;
Functionality
- From:
Herald of Medicine
2025;44(11):1757-1762
- CountryChina
- Language:Chinese
-
Abstract:
To promote the understanding of the requirements for metal materials and containers used for drug packaging in the 2025 edition of the Pharmacopoeia of the People's Republic of China for related enterprises.Based on this edition of the Chinese Pharmacopoeia,national standards for drug packaging materials,and relevant international standards such as the United States Pharmacopoeia(USP).The raw material selection,production process,and quality control indicators of metal pharmaceutical packaging materials were systematically sorted out.It was necessary to clarify that for the metal material itself,the base material and coating type should be selected based on the characteristics of the medicine.In terms of the production process,attention should be paid to the impact of the forming process on the material performance.In terms of quality control,it is necessary to combine the material characteristics and the drug requirements,and ensure its protection,safety,and functionality through standardized testing methods.By strengthening the quality control of metal pharmaceutical packaging materials,product quality can be ensured,and the innovative development of the industry can be promoted.
