ICP-MS determination of ten elemental impurities in meglumine
10.19778/j.chp.2024.05.004
- VernacularTitle:ICP-MS法测定葡甲胺中10种元素杂质的残留量
- Author:
Junmin LAI
1
;
Zhifang LI
;
Minshan ZENG
;
Juan ZHANG
;
Xiaohong YAN
Author Information
1. 广州市药品检验所,广州 510160
- Keywords:
meglumine;
ICH Q3D(R2);
ICP-MS;
elemental impurities;
excipient;
microwave digestion
- From:
Drug Standards of China
2024;25(5):452-457
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an ICP-MS method for the determination of 10 elemental impurities in meglu-mine(APIs).Methods:The samples were processed by closed high-pressure microwave digestion,and the con-tents of the Class 1 elemental impurities arsenic(As),cadmium(Cd),mercury(Hg)and lead(Pb),the Class 2 A elemental impurities cobalt(Co),nickel(Ni)and vanadium(V),and the Class 3 elemental impurities lithium(Li),antimony(Sb)and copper(Cu)were detected by ICP-MS with total quantification.Results:The linear correlation coefficients(r)of each elemental impurity were greater than 0.997.The recoveries of the spiked samples ranged from 93.6％to 116.8％with RSD values of the recoveries lower than 7.4％.RSD values of the precision were lower than 5.4％.The content of nickel in 11 batches of the samples was lower than the permissible daily exposure(PDE)of the impurities of the elements of category 2A in the elemental guideline of ICH Q3D(R2)for oral use but higher than that of PDE of the impurities of category 2A for injection.Conclusion:The method is sensitive and precise enough to accurately determine the levels of Class 1,2A and 3 elemental impurities in meglumine.Nine batches of meglumine were found to have a high risk of nickel residue.
