Establishment of Bacterial Endotoxin Test Method for Milrinone Raw Material

OBJECTIVE To establish bacterial endotoxin test method for milrinone raw material. METHODS Milrinone was dissolved with dimethylsulfoxide and then diluted by water for bacterial endotoxin test. The experiment was carried out according to the bacterial endotoxin test method indexed in the appendix of Ch.P 2010 Vol Ⅱ. Tachypleus amebocyte lysate from two manufacturers were used to for interference test. RESULTS According to the dose of clinical medication, the most suitable limit of bacterial endotoxin for milrinone was 13 EU·mg^-1. Under this experimental condition, the maximum noninterference concentration for milrinone was 0.5 mg·mL^-1. It was effective that bacterial endotoxin was tested by tachypleus amebocyte lysate with arbitrary sensitivity on the market. CONCLUSION Bacterial endotoxin test can be used to control the quality of milrinone raw material.