ABSTRACT
A robust general inductively coupled plasma-mass spectrometry (ICP-MS) based method was developed as an alternative to the wet chemical heavy metals test prescribed in the United States Pharmacopoeia (USP), British Pharmacopoeia (BP), Japanese Pharmacopoeia (JP) and European Pharmacopoeia (EP). The described method provides specific detection and quantitation for each of the elements expected to give rise to a positive response in the compendial methods: arsenic (As), selenium (Se), cadmium (Cd), indium (In), tin (Sn), antimony (Sb), lead (Pb), bismuth (Bi), silver (Ag), palladium (Pd), platinum (Pt), mercury (Hg), molybdenum (Mo) and ruthenium (Ru). The subjectiveness of the visual based semi-quantitative comparison that is performed in the compendial methods is eliminated through the utilization of the ICP-MS. The described method has been in use for several years and its versatility has been demonstrated by successfully applying it to a wide variety of sample matrices. Analysis of the specific elemental data from the numerous sample matrices investigated indicates that there is no dependence of the various chemical functionalities contained in the sample matrices on the individual element recoveries. The average recovery for each element from the various sample matrices investigated ranged from 89 to 102%.
