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Objective: To establish an inductively coupled plasma mass spectrometry (ICP-MS) method to determine the contents of 10 elemental impurities in the pharmaceutical excipients sodium succinate according to the ICH Q3D elemental impurity guideline, and to provide a basis for the comprehensive evaluation of potential risks. Methods: According to the types of elements that needed to risk assessment and the permitted daily exposure (PDE) of the injection route, the single-component limit calculation method was used to calculate the limit and control threshold of each element in sodium succinate with 10 g · d-1 as the maximum daily dose.Samples were preprocessed by direct dissolution and the iCAP RQ ICP-MS was used for the simultaneous determination of the residual amounts of 10 impurities in sodium succinate, using Ge, In and Bi as the internal standards. Results: All elemental impurities showed good linear relationship (r>0.99). The limits of detection of Cd, Pb, As, Hg, Co, V, Ni, Li, Sb and Cu were 0.27，19.22，8.86，16.63，0.12，0.28，1.48，6.91，0.35，9.26 ng · g-1, respectively. The recoveries (n=3) of each concentration were between 82.4% and 130.9%, and the RSD (n=6) of the repeatability test was not more than 7.1%, with all findings meeting the requirements for methodological validation. The content of elemental impurities in sodium succinate was less than 30% of the PDE,indicating that the elemental impurities in sodium succinate had no potential safety risk with the medicinal product. Conclusion: The method is simple in sample pretreatment, with high sensitivity and good accuracy. It is suitable for monitoring and risk assessment of elemental impurities in sodium succinate, which is conducive to the quality control. It also provides a reference for the determination of elemental impurities in other products.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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