Bacterial endotoxin test for tinidazole injections

Abstract

Objective To establish the best bacterial endotoxin test for tinidazole injections and to search the feasibility of bacterial endotoxin test for monitoring pyrogens of tinidazole injections. Methods Tachypleus amebocyte lysate could test the samples if they did not have interference, so the interference test was very important. It could judge whether the bacterial endotoxin test can be used in the samples. The interference test was conducted on three lots of tinidazole injections with two products of tachypleus amebocyte lysate (TAL) reagent according to the appendix XI E of Chinese. Pharmacopeia (2005) vol Ⅱ. The dilution times of the sample should be in the maximum valid dilution. And then proceed to bacterial endotoxin test. The finding of the bacterial endotoxin test was compared with the result of pyrogen test. Results Three lots of Tinidazole injection diluted up to two times did not interfere with bacterial endotoxin as the sensitivity of tachypleus amebocyte lysate was 0.25 EU/mL. The result of bacterial endotoxin test was the same as the pyrogen test.Conclusions Bacterial endotoxin test can be used to replace pyrogen test. Key words: Tinidazole injection; Bacterial endotoxin; Tachypleus amebocyte lysate