OBJECTIVE: To establish the bacterial endotoxin test method of Ossotide injection. METHODS: According to the appendix of the gel method under “bacterial endotoxin test method” in Chinese Pharmacopiea (2015 edition), the maximal non-interference concentrations of samples were determined by interference test, and then methodology validation was conducted. RESULTS: The agglutination of LAL with bacterial endotoxin had no interference when the sample was diluted to 0.333 mg/ml or below. CONCLUSIONS: The established method can be used to detect the bacterial endotoxin of Ossotide injection.
关键词
骨肽注射液细菌内毒素检查凝胶法干扰试验
Keywords
Ossotide injectionBacterial endotoxin testGel methodInterference test