Determination of elemental impurities in pharmaceutical excipients polysorbates by ICP-MS
10.19778/j.chp.2025.02.006
- VernacularTitle:ICP-MS法检测聚山梨酯类药用辅料中元素杂质的残留量
- Author:
Yajuan GUO
1
;
Shaowen YU
1
;
Shujun HU
1
;
Caimei WANG
1
Author Information
1. 广东省药品检验所,国家药品监督管理局药用辅料质量控制与评价重点实验室,广州 510663
- Publication Type:Journal Article
- Keywords:
polysorbates;
ICH Q3D(R2);
ICP-MS;
elemental impurities
- From:
Drug Standards of China
2025;26(2):151-155
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish ICP-MS method for determining the Class 1 and Class 2A elemental impurities in pharmaceutical excipients polysorbates according to ICH Q3D(R2)Guidelines.Class 1 elemental impurities include As,Cd,Hg and Pb;Class 2A elemental impurities include Co,Ni and V.Methods:The analysis was performed using ICP-MS with the following parameters.Plasma mode:HMI-8,carrier gas:He,sampling depth:10.0 mm.RF power:1 600 W,the carrier gas flow,the nebulizer gas flow and the auxiliary gas flow were all 0.8 L·min-1.The plasma gas flow was 15.0 L·min-1.The speed of nebulizer pump was0.10 r·min-1.The temperature of atomizer chamber was 2.0℃.Analytical method:internal standard method.Results:The correla-tion coefficient for all elemental impurities was not less than 0.999.Spiked recoveries ranged between 85%-115.0%,with RSD is not more than 5.0%.The RSD of precision rate was not more than 10.0%.The contents of 7 elemental impurities in 15 batches of the samples were all less than PDE for injection set by ICH Q3D(R2)guidelines.Conclusion:The developed ICP-MS method demonstrates high sensitivity,good precision,and accuracy,making it suitable for controlling the Class 1 and Class 2A elemental impurities in polysorbate pharma-ceutical excipients.The results shows low risks of elemental impurities in commercial pharmaceutical excipients polysorbates.
