Method of Bacterial Endotoxins Test in Flumazenil Bulk Drug

VernacularTitle:氟马西尼原料药中细菌内毒素检查
Author: Yating YANG ^{1
,

2} ; Xiaojun LYU ; Ju ZHANG ; Xiaoling XU ; Kaiyong HE ; Jiate SHEN
Author Information

1. 湖北省药品监督检验研究院,武汉 430075
2. 湖北省药品质量检测与控制工程技术研究中心,武汉 430075
Keywords: Flumazenil; Bacterial endotoxin; Interference test
From: Herald of Medicine 2024;43(9):1470-1476
CountryChina
Language:Chinese
Abstract: Objective To establish a method for bacterial endotoxin test of flumazenil bulk drug.Methods According to the bacterial endotoxin test(BET)method in general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),flumazenil was dissolved with dimethyl sulfoxide(DMSO)and diluted with BET water.The gel-clot method and kinetic turbidimetric assay were used to carry out the interference test and endotoxin recovery test.Results Flumazenil was dissolved with DMSO to 10 mg·mL-1,and then diluted 100 times or more by BET water,which has no interference effects on the bacterial endotoxin test.Conclusion The BET method established in this study can be used to control the quality of flumazenil by performing bacterial endotoxin tests.