Objective:This study aims to assess the feasibility of using the recombinant Factor C method to detect bacterial endotoxins in paclitaxel.Methods:Paclitaxel was dissolved in a 1∶1 solution of Tween-80 and anhydrous ethanol,and its bacterial endotoxins levels were measured using the recombinant Factor C method.This method was validated in terms of robustness,accuracy,and precision.Results:The results indicate that when paclitaxel,dissolved in Tween-80 and ethanol,is further diluted with endotoxin-free water to a concentration of 0.017 mg/ml or lower,(with Tween-80 and ethanol concentrations not exceeding 0.35‰),the recombinant Factor C method effectively detects bacterial endotoxins without interference The method demonstrates strong robustness,accuracy,and precision.Conclusion:The recombinant Factor C method is a feasible method for detecting bacterial endotoxins in paclitaxel.
关键词
重组C因子法/紫杉醇/细菌内毒素检测/难溶性药物/吐温-80
Key words
recombinant Factor C method/paclitaxel/bacterial endotoxin test/insoluble drug/Tween-80
维普
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