Establishment of Bacterial Endotoxins Test for Brozopine / 中国药师
China Pharmacist
; (12): 2010-2012, 2015.
Article
en Zh
| WPRIM
| ID: wpr-670098
Biblioteca responsable:
WPRO
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.
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Base de datos:
WPRIM
Idioma:
Zh
Revista:
China Pharmacist
Año:
2015
Tipo del documento:
Article