4.6 Article

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

Journal

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Volume 23, Issue 5, Pages 867-890

Publisher

PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/S0731-7085(00)00361-7

Keywords

inductively coupled plasma-mass spectrometry; United Slates Pharmacopoeia; heavy metals limit test; drug substances

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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.

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