Verification and Comparative Experiment of Micro Dynamic Colorimetric Method(mKC)for Detecting Bacterial Endotoxin Content in Antibody Drugs
Objective:To detect the content of bacterial endotoxin in antibody drugs by micro dynamic chromogenic assay(mKC),verify the method,and compare the results with gel method.Methods:The micro dynamic chromogenic limulus lysate from two manufacturers was used to verify the methodology of three batches of samples from the linearity and range of the standard curve,the lower limit of quantification,the detection limit,the interference experiment,and the precision.At the same time,the results of the micro dynamic chromogenic method and the gel method were compared.Results:The absolute value(|r|)of the correlation coefficient of the standard curve is greater than 0.980,the linear range is 10～0.1 EU/mL,the lower limit of quantification is 0.1 EU/mL,and the detection limit is 0.025 EU/mL.It is determined that the non-interference mass concentration of the test solution is 0.2 mg/mL,and the RSD of the reagent from the same manufacturer is less than 25％.The RSD of six results of the reagents from two manufacturers is less than 30％.The results of the micro dynamic color method and the gel method are consistent.Conclusion:The micro dynamic color method can be used to detect the bacterial endotoxin content of antibody drugs,and can replace the traditional gel method for the release detection and stability inspection of antibody drugs.
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