Study on System Suitability Test for Determination of Related Substances of Insulin Glargine
Objective:To study on system suitability test for determination of related substances of insulin glargine in different enterprises,and identify existing problems,so as to prompt enterprises to improve quality standards and control product quality more scientifically and effectively.Methods:The system suitability test for determination of related substances of insulin glargine in different enterprises was studied by HPLC and LC-MS/MS,and multiple problems were found.Results:The structures of"0A-insulin glargine"confirmed by LC-MS/MS were different from the theoretical sequence in some enterprises.There are many problems of system suitable solution prepared by enzyme digestion in some other enterprises,such as more impurities,complex operation steps,turbidity of the solution and so on.Conclusion:It is suggested that the enterprises should pay more attention to the system suitability test,strengthen the research and improve the quality standards,so as to carry out the drug quality control scientifically and effectively.
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