Detection of bacterial endotoxin in compound electrolyte injection by kinetic turbidimetric assay
To establish a kinetic turbidimetric assay(KTA)for the detection of bacterial endotoxin in compound electrolyte injection.The limit(L)of bacterial endotoxin was determined to be 0.5EU/mL,the standard curve for detection of bacterial endotoxin by KTA was plotted,the interference of samples on the detection of bacterial endotoxin was investigated,the recovery rate of the bacterial endotoxin at different dilution multiples was analyzed,and the validation test was carried out.The results showed that the linear range of bacterial endotoxin concentration was 0.010 42-2.000 0 EU/mL.When the test sample was diluted by 20-40 multiples,the recovery rate of bacterial endotoxin was in the range of 50％-200％,the coefficients of variation(CV)of accuracy test and precision test were less than 10％.The content of bacterial endotoxin in three batches of samples was less than the limited value,and the recovery rate was in the range of 64％-75％.The method is rapid,simple,sensitive and anti-interference,which can be used for the quantitative detection of bacterial endotoxin in compound electrolyte injection.
万方数据
维普
