1.
China Pharmacist
;
(12): 365-368, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-705535
ABSTRACT
Objective:To establish the bacterial endotoxin test for HSSYO-001-3S. Methods: HSSYO-001-3S was dissolved in dimethylsulfoxide,diluted by BET water and centrifuged,and then the supernatant was used for the bacterial endotoxin test. The ex-periment was carried out according to the gel-clot technique for bacterial endotoxin inspection and the related regulations in Chinese Pharmacopoeia (2015 edition,volumeⅣ,general rule 1443). Results:HSSYO-001-3S was added with cosolvent and diluted by BET water to 1 mg·ml-1,and there was no interference effects to bacterial endotoxin test from the supernatant diluted four times or more. Conclusion:Bacterial endotoxin test can be used to control the quality of HSSYO-001-3S.