A multi-element ICP-MS survey method as an alternative to the heavy metals limit test for pharmaceutical materials.
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.
Wang
T
T
Analytical Research Department, Merck Research Laboratories, Rahway, NJ 07065-0900, USA. tiebang-wang@merck.com
Wu
J
J
Hartman
R
R
Jia
X
X
Egan
R S
RS
D002138:Calibration; D007202:Indicators and Reagents; D013058:Mass Spectrometry; D019216:Metals, Heavy / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis*; D010602:Pharmacopoeias as Topic; D012015:Reference Standards; D015203:Reproducibility of Results
D007202:Indicators and Reagents; D019216:Metals, Heavy; D004364:Pharmaceutical Preparations