Determination of Aluminum in Fat Emulsion Injection by ICP-MS and Quality Evaluation
Objective:To establish a method for the determination of aluminum content in fat emulsion injection and explore its reasonable limit range.Methods:The aluminum content of 69 batches of fat emulsion injection produced by 15 enterprises was determined using ICP-MS.The selection of internal standard elements,quantitative methods,media,sample pretreatment methods,and methodological establishment of fat emulsion injection in ICP-MS were studied.Results:There was a good linear relationship of ICP-MS in the concentration range of 0.5 ng∙mL-1～5.0 ng∙mL-1(r=0.9999),and the average recovery was 101.1%,RSD=1.83%(n=9).Conclusion:ICP-MS method is suitable for the determination of aluminum ion content in fat emulsion injection.There is a significant difference in residues of aluminum between the products from different manufacturers and it is necessary to control residual aluminum in fat emulsion injection.
万方数据
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