Abstract
Elemental impurities in drug products have no therapeutic effect and may pose toxicological concerns, therefore it is urgent to assess the safety of elements especially in parenteral exposure drug. In the present work, a high throughput inductively coupled plasma mass spectrometry (ICP-MS) method was developed for the quantitative determination of 31 elemental impurities in bromhexine hydrochloride injections from 9 manufactures. The method was successfully validated for linearity, accuracy, precision, stability, the LOD and the LOQ according to the United States Pharmacopeia (USP) < 233 > . All the elemental impurities determined were below the permitted daily exposure (PDE) limits proposed by the International Council for Harmonisation (ICH). However, significant differences were found between different manufactures’ products for some elements, particularly for Al, As, B, Ba and Zn. Besides, discussions considering potential risks of elemental contamination were also presented.
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