Investigation on bacterial endotoxins test of fructose sodium diphosphate injections
- VernacularTitle:果糖二磷酸钠注射液与注射用果糖二磷酸钠细菌内毒素检查方法学研究
- Author:
Yejun QIAO
1
;
Haolan RUAN
1
;
Suzhen CHEN
1
;
Zimin XU
1
;
Shuxia HUO
1
;
Sen WENG
1
;
Qi CHEN
1
Author Information
- Publication Type:Journal Article
- Keywords: fructose sodium diphosphate; FDP injections; bacterial endotoxin; methodological research; limits; in-terference test; quality control
- From: Drug Standards of China 2025;26(5):543-548
- CountryChina
- Language:Chinese
- Abstract: 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.
