Determination and risk analysis of potential N-nitrosodimethylamine in azithromycin injections
Objective To explore the determination and risk of potential N-nitrosodimethylamine in azithromycin injection.Methods According to the Food and Drug Inspection and Testing Center of Zaozhuang City based on the relevant guidelines issued by US Food and Drug Administration (FDA) and European Medicines Agency (EMA),the structure and characteristics of azithromycin were analyzed in combination with degradation experiments,and the risk of N-nitrosamine was identified,the control limit was clearly defined.High performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) was constructed to determine the potential N-nitrosodimethylamine in azithromycin injections.Results Accuracy:Appropriate amount of solution was added into the test product (batch number:191013) and configured as limit of quantification (LOQ) solution with different concentration levels (50％,100.00％,150.00％),and the recovery rate WAS 85.9％-101.8％,with an average (n=12) of 94.2％,and the relative standard deviation (RSD) was 5.4％.Conclusion The N-nitrosodimethylamine (NDMA) risk in azithromycin injection on the market is controllable,and HPLC-MS/MS detection can meet the limited requirements of sensitivity,and the specific recovery rate has a good recovery degree,which is convenient for quality testing institutions at all levels to accurately assess the NDMA risk in azithromycin,so as to strengthen quality control risk measures.At the same time,it also provides an effective identification basis for monitoring the potential risk assessment of N-nitrosodimethylamine in chemical synthesis.
Azithromycin injectionsN-nitrosodimethylamineUS Food and Drug AdministrationEuropean Medicines AgencyRisk
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