Determination and analysis of twenty-four metallic elements in polysorbate 80
10.19778/j.chp.2024.05.016
- VernacularTitle:聚山梨酯80中24种金属元素的测定及分析评价
- Author:
Yajuan LEI
1
,
2
;
Yun JIANG
;
Yong ZHAO
;
Changliang LI
;
Yanming LIU
;
Yue ZHANG
Author Information
1. 湖南省药品检验检测研究院,长沙 410001
2. 国家药品监督管理局药用辅料工程技术研究重点实验室,长沙 410001
- Keywords:
polysorbate 80;
ICP-MS;
metallic elements;
statistical analysis;
risk assessment
- From:
Drug Standards of China
2024;25(5):521-525
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an inductively coupled plasma-mass spectrometry(ICP-MS)method for the determination of 24 elements in polysorbate 80,and evaluate the results.Methods:The elements were determined by ICP-MS,statistical analysis was conducted using SPSS 26,and the risk assessment was carried out with reference to ICH Q3D guidelines.Results:The standard curves showed good linear relationship in the corresponding concentration range(r=0.997-0.999).The recoveries were 88.81％-134.64％(RSD＜5％,n=6).None of the elements recommended for evaluation exceeded the control threshold.Conclusion:The method is accurate,reliable and easy-to-operate,and the risk of elemental impurities in this sample is low.
