OBJECTIVE: To establish a method for the bacterial endotoxin test of Ibuprofen sodium chloride injection. METHODS: Maximum noninterference concentration of sample was determined by interference test according to bacterial endotoxins gel-clot test stated in the general principles 1143 of Chinese Pharmacopoeia 2015 edition (four). And then methodology validation was conducted. RESULTS: Samples were diluted to 1 mg/mL, which did not interfere with bacterial endotoxin test. CONCLUSIONS: The established method can be used for the bacterial endotoxin test of Ibuprofen sodium chloride injection, and the limitation of bacterial endotoxin was 0.5 EU/mL.
关键词
布洛芬氯化钠注射液细菌内毒素检查干扰试验
Keywords
Ibuprofen sodium chloride injectionBacterial endotoxin testInterference test