Establishment of Bacterial Endotoxins Test for Brozopine / 中国药师
China Pharmacist
;
(12): 2010-2012, 2015.
Article
in Chinese
| WPRIM
| ID: wpr-670098
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacist
Year:
2015
Type:
Article
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