Quantitative Determination of Bacterial Endotoxin in Isepamicin Sulfate Injection by Kinetic Turbidimetric Assay / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the determination of the bacterial endotoxin content in isepamicin sulfate injection. METHODS: By using tinetic turbidimetric assay in which the sample was subjected to a serial dilution and the detection concentration of the sample was established by interference tests, meanwhile the standard endotoxin working curve was established for quantitative determination of the bacterial endotoxin in samples. RESULTS: The results showed that at a concentration of 6.25 mg?mL-1, isepamicin sulfate injection did no interference on tachypleus amebocyte lysate test. The bacterial endotoxin recovery ranged form 50% to 200%. CONCLUSIONS: It is feasible to use kinetic turbidimetry assay for the determination of bacterial endotoxin in isepamicin sulfate injection.