Bacteria Endotoxin Test of Vitamin B₆ for Injection

OBJECTIVE To establish the bacterial endotoxin test of vitamin B6 for injection. METHODS The experiment was carried out according to the appendix of ChP 2010 Vol Ⅱ. tachypleus amabocyte lysate from two manufacturers were used to test the bacterial endotoxin. RESULTS The endotoxin limit of vitamin B₆ for injection was 0.30 EU·mg^-1. The reactions were not disturbed in 0.208 mg·mL^-1 for vitamin B₆, which was the maximum nondisturbing concentration. It was effective that endotoxin was tested by amebocyte lysate agent with the sensitivity of 0.06 EU·mL^-1 or much higher. CONCLUSION It is feasible to control quality of vitamin B₆ for injection by bacterial endotoxin test.