Abstract: OBJECTIVE To establish bacterial endotoxin test method for clevidipine butyrate. METHODS Clevidipine butyrate was dissolved with 60% ethanol 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 for interference test. RESULTS According to the dose of clinical medication, the most suitable limit of bacterial endotoxin in preparations for clevidipine butyrate was 4.7 EU·mg^-1. Under this experimental condition, the maximum noninterference concentration for clevidipine butyrate was 0.013 3 mg·mL^-1. It was effective that bacterial endotoxin was tested by tachypleus amebocyte lysate with the sensitivity of 0.06 EU·mL^-1 or higher sensitivity. CONCLUSION This method can be used in bacterial endotoxin test of clevidipine butyrate and can be applied to control its quality.