Evaluation of the safety of metallic elements in borosilicate glass controlled injection bottle by ICP-MS
10.7501/j.issn.1674-6376.2017.11.008
- VernacularTitle:电感耦合等离子体发射光谱-质谱法测定硼硅玻璃管制注射剂瓶中的金属元素
- Author:
chun Ai JU
1
;
Chao PAN
;
yan Hai LI
;
shui Hong YUE
Author Information
1. 天津天士力之骄药业有限公司
- Keywords:
medium/low borosilicate glass controlled injection bottle;
ICP-MS;
metal element;
injection safety
- From:
Drug Evaluation Research
2017;40(11):1569-1575
- CountryChina
- Language:Chinese
-
Abstract:
Objective Determination of extractable components in medium/low borosilicate glass controlled injection bottles under 5 different extraction conditions,assess the risk of drug safety by the amount of migration.Methods Determination of 24 elements in extraction solution by ICP-MS.Result Establish the standard curves of 24 elements,and the detection limit and quantitative limit were determined.The determination of the elements in the 5 extraction solutions was completed and their safety was evaluated.Conclusion Medium/low borosilicate glass injection bottle for packing freeze-dried products of Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,the daily intake of Li、V、Cr、Fe、Co、Ni、Cu、Zn、As、Cd、Sb、Ba、Hg、Pb was lower than permitted daily exposure,the amount of migration does not pose a risk to drugs,therefore,the injection quality is not affected.
