Investigation on bacterial endotoxin in nafamostat mesilate for injection by kinetic chromogenic assay
10.19778/j.chp.2024.02.014
- VernacularTitle:动态显色法在注射用甲磺酸萘莫司他细菌内毒素检查的运用分析
- Author:
Rongrong WANG
1
;
Yingya CAO
;
Yunxia WANG
;
Zheng MA
;
Huan LIU
;
Xiaowen ZHOU
Author Information
1. 南京华威医药科技集团有限公司,南京 210000
- Keywords:
nafamostat mesilate for injection;
serine protease inhibitor;
the interference;
alkaline regulator;
kinetic chromogenic assay;
bacterial endotoxin
- From:
Drug Standards of China
2024;25(2):195-199
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a bacterial endotoxin test method for nafamostat mesilate for injection.Methods:The interference test of the bacterial endotoxin test method-kinetic chromogenic assay was carried out according to the Chinese Pharmacopoeia 2020 Volume Ⅳ general chapter 1143.Results:The interference effect of naphtholimus mesylate can be effectively eliminated by treating the test solution with an alkaline regulator for a certain period of time and diluting it.Conclusion:The bacteria endotoxin test-kinetic chromogenic assay for nafa-mostat mesilate for injection is applicable.
