Sodium Oleate(for injection)Metal Element Impurity Detection and Safety Level Analysis
In order to analyze the safety level of metal element impurities in sodium oleate(for injection),a detection method for metal element impurities in sodium oleate(for injection)was established,and 6 batches of samples were tested and analyzed for their safety level.Sodium o-leate(for injection)was microwave-assisted using nitric acid.The content of 11 metal elements,including Cd,Pb,As,Hg,Co,V,Ni,Li,Sb,Cu,and Cr,was detected by ICP-MS,and a methodological study was conducted on this method.The results show that the correlation co-efficients of all 11 metal elements are ≥0.99,showing a linear relationship within a certain concentration range of quality;The precision is be-tween 1.1％and 7.4％;The average accuracy is between 95.0％and 105.0％;Good repeatability with RSD of 1.1％～8.4％.The above data indicates that this method is accurate and sensitive,and can be used for the detection of metal element impurities in sodium oleate(for in-jection).This method was used to detect 6 batches of sodium oleate samples from different sources,and the detected samples did not exceed the control threshold.The results of this study can provide reference for the safety level of metal element impurities in sodium oleate(for injection).
万方数据
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