Abstract : The objective of the research is to study on the test for Bacterium Endotoxins
of Ozagrel Sodium Injection and to confirm test limit. The inhibition and enhancement test is studied with different products of Ozagrel Sodium Injection. Tachypleus amebocyte lysate which sensitivity are 0.25EU/mL and 0.03EU/mL had been used. The test was not disturbed by Ozagrel Sodium Injection. So the test for bacterial endotoxin of Ozagrel Sodium Injection can be carried out. According to inspection (People's Republic of China Pharmacopoeia 2005 version 2 Ⅺ Appendix E), The concentration of toxins in Ozagrel Sodium injection should be less than 0.625 EU /mg. The result was 0.625 EU /mg.It
accord with the criterion.
Keywords: Ozagrel Sodium for Injection; bacterial endotoxin test; tachypleus amebocyte lysate; Interference test