Bacterial Endotoxins Test of Chlorphenamine Maleate Injection
- VernacularTitle:马来酸氯苯那敏注射液的细菌内毒素检查
- Author:
Chun LIU
;
Yumei ZHAO
- Publication Type:Journal Article
- Keywords:
Chlorphenamine maleate injection;
Bacterial endotoxins;
Tachypleus amebocyte lysate;
Interference test
- From:
China Pharmacy
2007;0(25):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the bacterial endotoxin test of chlorphenamine maleate injection. METHODS: The interference test and bacterial endotoxin test of 28 batches of chlorphenamine maleate injections from 14 manufacturers were carried out in accordance with the bacterial endotoxin test approved by Chinese Pharmacopeia (2005 edition). RESULTS: Diluted to a concentration of below 0.025 mg?mL-1,the samples showed no interference action on bacterial endotoxin test. The limit value of the bacterial endotoxin was 5 EU?mg-1. The results of the bacterial endotoxin test of the 28 batches of samples were all accorded with the standard of the established quality control. CONCLUSION: The established TAL method is applicable for bacterial endotoxin test of chlorphenamine maleate injection.
