A multi-element ICP-MS survey method as an alternative to the heavy metals limit test for pharmaceutical materials

被引:74
作者
Wang, TB [1 ]
Wu, J [1 ]
Hartman, R [1 ]
Jia, XJ [1 ]
Egan, RS [1 ]
机构
[1] Merck Res Labs, Analyt Res Dept, Rahway, NJ 07065 USA
关键词
inductively coupled plasma-mass spectrometry; United Slates Pharmacopoeia; heavy metals limit test; drug substances;
D O I
10.1016/S0731-7085(00)00361-7
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A multi-element inductively coupled plasma-mass spectrometry (ICP-MS) survey method has been demonstrated as an alternative to the antiquated 'heavy metals limit test' prescribed by United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and British Pharmacopoeia (BP), for drug substances, intermediates, and raw materials. The survey method is simple, fast, sensitive, semi-quantitative to quantitative, and includes all the elements which can be analyzed by atomic spectroscopy. (C) 2000 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:867 / 890
页数:24
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