Method of Bacterial Endotoxin Test of Fluorescein Sodium Injection
- VernacularTitle:荧光素钠注射液细菌内毒素检查法的研究
- Author:
Weisong PAN
;
Jianming PAN
- Publication Type:Journal Article
- Keywords:
Fluorescein sodium injection;
Bacterial endotoxin test method;
Tachypleus amebocyte lysate;
Interference test
- From:
China Pharmacy
2005;0(13):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To establish a bacterial endotoxin test method for fluorescein sodium injection.METHODS: Based on the bacterial endotoxin test method stated in Chinese Pharmacopoeia 2005 edition(second part),an interference test was conduced on different batches of fluorescein sodium samples using tachypleus amebocyte lysate from different companies.RESULTS: At a concentration of no more than 0.75 mg?mL-1,fluorescein sodium showed no interfere with the bacterial endotoxin test.CONCLUSION: It is feasible for bacterial endotoxin test of fluorescein sodium injection be conducted in a limit value of 0.15 EU?mL-1.
