Abstract
Calcium carbonate mineral medicine contains many unknown elemental impurities; however, the detection strategies of the elemental impurities in calcium carbonate differ in various national pharmacopoeias, hindering accurate quantification and risk assessment. In this study, a simple and rapid inductively coupled plasma mass spectrometry method was developed for the detection of 31 elemental impurities in the calcium carbonate mineral medicine by using the collision-reaction cell technique, which could eliminate the mass spectral interference by the complex polyatomic ion. In addition, the isotope ratios were used as a control parameter parameter. The detection result of the proposed method could meet the United States Pharmacopoeia 223, while the risk assessment was performed following the International Conference on Harmonization (ICH) Q3D guidelines. Our results provided a promising strategy for screening and quantitative detection of 31 elemental impurities in calcium carbonate formulations.
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