Considerations on the Standard Setting of Shading Property for Colored Glass Containers in Chinese Pharmacopeia
10.3870/j.issn.1004-0781.2025.04.005
- VernacularTitle:《中华人民共和国药典》有色玻璃容器遮光性标准设定的思考
- Author:
Xiaoxu HAN
1
;
Yanfei QI
1
;
Xia ZHAO
1
Author Information
1. 中国食品药品检定研究院,北京 100050
- Publication Type:Journal Article
- Keywords:
Colored glass containers;
Shading property;
Chinese Pharmacopeia;
Standard system
- From:
Herald of Medicine
2025;44(4):532-535
- CountryChina
- Language:Chinese
-
Abstract:
Objective Interpret the method of determining the shading property for colored glass containers in the Chinese Pharmacopoeia(2025 edition)in detail,and provide theoretical guidance and technical support for the implementation of standards.Methods By summarizing and analyzing the related abroad standards for shading property of colored glass containers,combining with the results of experimental verification,the method for determining the shading property of colored glass containers was established in accordance with the requirements of the construction of the pharmaceutical packaging material system in the Chinese Pharmacopoeia.An explanation was provided for the selection of instruments and equipment,the requirements for the preparation of the samples,and the way of expressing the results.Results The method of determining the shading property for colored glass containers,formulated in conjunction with international standards,proposed scientifically reasonable operational requirements based on solid experimental verification data,and solved the problem of having no"method"to follow in the domestic shading property measurement.Conclusion The proposal of the method for determining the shading property of colored glass containers filled the industry gap,improved the pharmaceutical packaging material standard system,standardized the method operation,and was conducive to promoting industrial development and ensuring the safety of formulations.
