Determination of Contents of 15 Elemental Impurities in Kits of Dimercaptosuccinate Acid and Stannous Chloride for Injection by ICP-MS

doi:10.19803/j.1672-8629.20240572

Abstract

Abstract: Objective To establish an inductively coupled plasma mass spectrometric (ICP-MS) method for the determination of elemental impurities in kits of dimercaptosuccinate acid and stannous chloride for injection. Methods The elements in kits of dimercaptosuccinate acid and stannous chloride for injection were screened using ICP-MS in a semi-quantitative mode. The elemental impurities were determined before being examined and controlled as required by the ICH Q3D guidelines for elemental impurities. There were 15 elements: Li, Al, K, V, Fe, Co, Ni, Cu, Zn, As, Cd, In, Sb, Hg and Pb, which were chosen as the subjects. The kinetic energy discrimination (KED) mode was selected for ICP-MS while Sc, Ge, Y and Bi were used as the internal standards. The sampling was repeated three times to determine the average value. Results The contents of five elements-Al, K, Fe, Zn and In-were found to be relatively high in the kit of dimercaptosuccinate acid and stannous chloride for injection after elemental screening. The results of determination of elemental impurities of products by different enterprises revealed characteristics of distribution. Methodological validation indicated that the impurities of each element were within the linear range and correlated (r >0.991 7), and that the precision (RSD≤3.72%) and reproducibility (RSD≤3.53%) of the method met the requirements, with the average recoveries of these elements ranging from 93.45% to 105.38% (RSD≤4.28%, n=9), and the accuracy was good. Conclusion Metal salts may introduce impurities of elements other than those required by ICH Q3D guidelines. The method established in this study is simple, rapid and can meet the requirements for the detection and risk evaluation of elemental impurities in the kit of dimercaptosuccinate acid and stannous chloride for injection.

Key words: Kit of Dimercaptosuccinate Acid and Stannous Chloride, Injection, Elemental Impurities, Semi-quantitative Screening, Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Quantitative Analysis

CLC Number:

R917

YAO Jing, LIAN Xiaofang, ZUO Limin, GUO Xin, LIU Huiyi, GU Yongsheng, JIA Qingying, HUANG Haiwei. Determination of Contents of 15 Elemental Impurities in Kits of Dimercaptosuccinate Acid and Stannous Chloride for Injection by ICP-MS[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 53-57.

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