ICP-MS在药品质量控制中应用的研究进展OA

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.