Investigation on the Applicability of Bacterial Endotoxins Test Using Recombinant Factor C in Tulathromycin Injection for Detection of Bacterial Endotoxin
A recombinant C-factor bacterial endotoxin assay was established for tulathromycin injection,and the linear range,accuracy,precision,specificity,detection limit and durability of the method were validated according to the<9101>Guidelines for the Verification of Veterinary Medicine Quality Analysis Methods in Chinese Veterinary Pharmacopoeia ( Volume Ⅰ,2020 edition ),and compared with the dynamic colorimetric method.The recombinant C-factor method showed good linear relationship with logδRFU in the range of 0.005～5 EU/mL for endotoxin standards,with r>0.980;the recoveries were in the range of 50％-200％,and the coefficients of variation were less than 10％,which were weakly variable;the recombinant C-factor did not react with β-glucan,and the dynamic colorimetric method detected the concentration of β-glucan at 0.47 EU/mL;the detection limits were 0.005 EU/mL;the slopes,intercepts and measured values were not affected by the change of gain values.The recombinant C-factor method has good accuracy,precision,specificity and durability,and can be applied to the examination of bacterial endotoxin in veterinary special injection.
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