Validation of endotoxin test for high concentration vitamin B6 injection / 药学实践杂志
Journal of Pharmaceutical Practice
; (6): 67-70, 2020.
Article
in Zh
| WPRIM
| ID: wpr-782387
Responsible library:
WPRO
ABSTRACT
Objective To establish a bacterial endotoxin test method for high concentration vitamin B6 injection. Method The test was taken according to the bacterial endotoxin test in Chinese pharmacopoeia 2015 edition. Result By diluting the sample concentration to 1.04 mg/ml with the buffer of pH6.5-7.5, and using λ=0.06 EU/ml of TAL reagent, the interference could be effectively avoided. Conclusion The method was useful, which could be used to test the bacterial endotoxin in high concentration vitamin B6 injection. The bacterial endotoxin limit was defined as 0.06 EU/mg.
Full text:
1
Index:
WPRIM
Language:
Zh
Journal:
Journal of Pharmaceutical Practice
Year:
2020
Type:
Article