医药导报2025，Vol.44Issue(11)：1763-1767,5.DOI:10.3870/j.issn.1004-0781.2025.11.006
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
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
摘要
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.关键词
中华人民共和国药典/指导原则/药品包装用铝箔/质量控制Key words
The Pharmacopoeia of the People's Republic of China/Guiding Principles/Pharmaceutical packaging aluminum foil/Quality control分类
医药卫生引用本文复制引用
饶艳春,熊炜,左军凤,陈蕾,付辉政,熊马剑,张芳芳,常亮..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[J].医药导报,2025,44(11):1763-1767,5.基金项目
国家药典委员会2023年度国家药品标准制修订研究课题(2023Y59-5) （2023Y59-5）
江西省重大科技专项(20223AAG02020). （20223AAG02020）
