Establishment of Bacterial Endotoxins Test for Brozopine
- VernacularTitle:布罗佐喷钠细菌内毒素检查法的建立
- Author:
Yan HE
;
Xiaoyue XU
;
Junxia ZHANG
- Publication Type:Journal Article
- Keywords:
Brozopine;
Bacterial endotoxin test;
Tachypleus amebocyte lysate;
Interfering factors test
- From:
China Pharmacist
2015;(11):2010-2012
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish bacterial endotoxin test for brozopine. Methods: Interference pre-test and interfering factors test were conduced on 3 batches of samples from 2 manufacturers to confirm the applicability of bacterial endotoxin test and the non-in-terfering concentration. The bacterial endotoxin test was carried out based on the method described in the second part of Chinese Phar-macopeia (2010 edition) and relevant standards and guidelines. Results: The three batches of brozopine showed no interference in bacterial endotoxin test at the concentration less than or equal to 2. 5 mg·ml-1 . The bacterial endotoxin test of the three bathes of samples all met the requirements. Conclusion:Bacterial endotoxin test can be used for the quality control of brozopine.
