Key Quality Control Items and Testing Points of Sheet for Oral Solid Preparation in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
10.3870/j.issn.1004-0781.2025.07.009
- VernacularTitle:2025年版《中华人民共和国药典》口服固体药用硬片关键质量控制项目及测试要点
- Author:
Xiaohui YU
1
;
Wei XIONG
;
Bin LIU
;
Yiwei ZHAO
;
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
- Publication Type:Journal Article
- Keywords:
Sheet for oral solid preparation;
Key quality control items;
Testing points;
the Pharmacopoeia of the People's Republic of China
- From:
Herald of Medicine
2025;44(7):1065-1069
- CountryChina
- Language:Chinese
-
Abstract:
To promote the understanding of the requirements of sheet for oral solid preparation in the Pharmacopoeia of the People's Republic of China(2025 edition)and improve the quality control level of related parties in production and use,the key quality control items specified in Pharmacopoeia of the People's Republic of China and the testing points were analyzed and discussed combined with the current situation of sheet for oral solid preparation industry and relevant standards at home and abroad.Suggestion was given that quality control should be carried out according to product characteristics,application,production process,and risk assessment,and reasonable limits should be set.
