Key Quality Attributes and Technical Control Points of Aluminum Foil for Pharmaceutical Packaging in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
10.3870/j.issn.1004-0781.2025.11.006
- VernacularTitle:2025年版《中华人民共和国药典》药品包装用铝箔关键质量属性和技术要点
- Author:
Yanchun RAO
1
;
Wei XIONG
;
Junfeng ZUO
;
Lei CHEN
;
Huizheng FU
;
Majian XIONG
;
Fangfang ZHANG
;
Liang CHANG
Author Information
1. 江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌 330029
- Publication Type:Journal Article
- Keywords:
The Pharmacopoeia of the People's Republic of China;
Guiding Principles;
Pharmaceutical packaging aluminum foil;
Quality control
- From:
Herald of Medicine
2025;44(11):1763-1767
- CountryChina
- Language:Chinese
-
Abstract:
Aluminum foil for pharmaceutical packaging is a material used for solid dosage forms.Guideline 9625 of the Pharmacopoeia of the People's Republic of China(2025 edition),built on the concepts of whole-process quality control and risk management,specifies the quality requirements for aluminum foil.This article analyzed and discussed the critical quality attributes and technical control points of aluminum foil by examining its fundamental characteristics,production processes,and relevant domestic and international standards.This article aimed to provide guidance for stakeholders in understanding and applying the guidelines,thereby enhancing pharmaceutical packaging quality and fostering standardization across the industry.
