Evaluation of the safety of metallic elements in borosilicate glass controlled injection bottle by ICP-MS / 药物评价研究

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.