Research on Determination Method of Particulate Matter in Drug Packaging Materials Based on the Pharmacopoeia of the People's Republic of China(2025 Edition)
10.3870/j.issn.1004-0781.2024.11.006
- VernacularTitle:《中华人民共和国药典》(2025年版)药包材不溶性微粒测定法研究
- Author:
Dongwei WANG
1
;
Wenli LI
;
Wei XIONG
;
Jing ZHANG
;
Lei CHEN
;
Kai XU
Author Information
1. 山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101
- Keywords:
Drug packaging materials;
Particulate matter;
Light obscuration particle count test;
Microscopic particle count test
- From:
Herald of Medicine
2024;43(11):1740-1744
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish and interpret of the Pharmacopoeia of the People's Republic of China(2025 Edition),to determine particulate matter in pharmaceutical packaging materials,and to provide further guidance and support for the later use of the standard.Methods By reviewing the existing problems in the use of Chinese pharmaceutical packaging materials standards(YBB standards)standards combined with the construction of new standard system for pharmaceutical packaging materials in the Pharmacopoeia of the People's Republic of China,also about the validation data of the pharmaceutical packaging materials,the scope、testing methods、requirements and the experimental parameters of the Pharmacopoeia of the People's Republic of China determination of particulate matter in pharmaceutical packaging materials are studied and interpreted in detail.Results Compared with the current YBB standard,the Pharmacopoeia of the People's Republic of China-determination of particulate matter in pharmaceutical packaging materials has solved the problems of incomplete application scope and unreasonable requirements and parameters in the YBB standard.Conclusion The content of the Pharmacopoeia of the People's Republic of China(2025 Edition)determination of the particulate matter in drug packaging materials method is more scientific、applicable and operable.This method can standardize the determination of a particulate matter in drug packaging materials and can also play a supporting role in the construction of the standard system to promote industrial development.
