Objective:To establish a quality standard for the bacterial endotoxin test method of fructose sodium diphosphate injections(FDP injections),so as to provide reference for the formulation and revision of the national standard for this drug.Methods:The interference test and bacterial endotoxins test of 22 batch samples of FDP in-jections from nine manufacturers were performed with TALs,and the bacterial endotoxins of samples were tested and the results were judged.Results:A bacterial endotoxin limit value of 0.72 EU·mg-1 for fructose sodium diphos-phate was established,which was suitable for 22 batches of FDP injections met the requirements.Conclusion:The bacterial endotoxin test method established in this study can be used to substitute the rabbit pyrogen test and meet the quality control requirements of FDP injections.

Objective:To establish a quality standard for the bacterial endotoxin test method of fructose sodium diphosphate injections(FDP injections),so as to provide reference for the formulation and revision of the national standard for this drug.Methods:The interference test and bacterial endotoxins test of 22 batch samples of FDP in-jections from nine manufacturers were performed with TALs,and the bacterial endotoxins of samples were tested and the results were judged.Results:A bacterial endotoxin limit value of 0.72 EU·mg-1 for fructose sodium diphos-phate was established,which was suitable for 22 batches of FDP injections met the requirements.Conclusion:The bacterial endotoxin test method established in this study can be used to substitute the rabbit pyrogen test and meet the quality control requirements of FDP injections.