Study on Testing for Bacterial Endotoxin in Ibuprofen

OBJECTIVE To establish a method of examining bacterial endotoxin for ibuprofen. METHODS To determine the reasonable limit of bacterial endotoxin by Chinese Pharmacopoeia 2010; and study on testing for bacterial endotoxin to determine the noninterference concentration for ibuprofen. RESULTS According the dose of clinical medication to determine the most suitable limit of bacterial endotoxin in preparations for ibuprofen was 0.20 EU·mg^-1 and uesd the TAL of two manufacturers to test, and it was proved that the maximum noninterference concentration was 0.625 mg·mL^-1 and the best testing concentration was no more than 0.625 mg·mL^-1. CONCLUSION It was showed that the method is suitable for the ibuprofen of bacterial endotoxin test.