中国药物评价2026，Vol.43Issue(1)：14-17,4.
ICP-MS在药品质量控制中应用的研究进展
Advances in the Application of ICP-MS in Pharmaceutical Quality Control
贾登营 1张杰 1李培 1庞博 1房霞 1王洪梅 1赵文法1
作者信息
- 1. 聊城市检验检测中心,山东聊城 252000
- 折叠
摘要
Abstract
Inductively coupled plasma mass spectrometry(ICP-MS)has been recognized by ICH Q3D(R2),USP<232>/<233>and the 2025 edition of the Chinese Pharmacopoeia as the preferred technique for elemental-impurity determination in pharmaceuticals,owing to its sub-ppt limits of detection,nine-order dynamic linear range,and simultaneous multi-element detection capability.After a sys-tematic introduction to the fundamentals and characteristics of ICP-MS,this review summarizes the most recent applications in quantifying heavy-metal residues,trace elements,and elementary speciation;discusses critical technical challenges—including matrix interference,species transformation,and sample preparation,and outlines future perspectives such as high-resolution mass spectrum,multidimensional hyphenation,and intelligent quality evaluation,so as to provide a reference for the control of elemental impurities in the full life circle of medicinal products.关键词
电感耦合等离子体质谱(ICP-MS)/药品质量控制/重金属/元素形态/方法学Key words
ICP-MS/Pharmaceutical quality control/Heavy metals/Elementary speciation/Methodology分类
医药卫生引用本文复制引用
贾登营,张杰,李培,庞博,房霞,王洪梅,赵文法..ICP-MS在药品质量控制中应用的研究进展[J].中国药物评价,2026,43(1):14-17,4.
