Validation of endotoxin test for high concentration vitamin B6 injection
10.3969/j.issn.1006-0111.201909108
- VernacularTitle:高浓度维生素B6注射液细菌内毒素检查方法学验证
- Author:
Juan SHEN
1
;
Jiayue LU
1
;
Xiaoru LUO
1
;
Xiwen WANG
1
Author Information
1. General Station for Drug & Instrument Supervision and Control, Joint Logistics Support Force, PLA, Beijing 100071, China.
- Keywords:
high concentration vitamin B6 injection.;
endotoxin;
gel-clot test method;
interference test
- From:
Journal of Pharmaceutical Practice
2020;38(1):67-70
- CountryChina
- Language:Chinese
-
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.
