OBJECTIVE: To provide reference for establishing the standard method for the bacterial endotoxin test in Compound amino acids (15AA) and dipeptide (2) injection. METHODS: The limit for bacterial endotoxin in Compound amino acids (15AA) and dipeptide (2) injection was designed according to Chinese Pharmacopoeia 2015 edition (four), and both gel-clot method and kinetic turbidimetric limulus test were conducted for detecting the samples’ interference to bacterial endotoxin test. RESULTS: After being adjusted to a near neutral pH, samples showed no interfered to bacterial endotoxin in both methods when the sample was diluted to 4 times. CONCLUSIONS: Both gel-clot method and kinetic turbidimetric limulus test can be used for the bacterial endotoxin test in Compound amino acids (15AA) and dipeptide (2) injection. Gel-clot method is recommended due to the large fluctuations of recovery rate in kinetic turbidimetric limulus test.
关键词
复方氨基酸(15AA)双肽(2)注射液细菌内毒素检查干扰试验凝胶法动态浊度法
Keywords
Compound amino acids (15AA) and dipeptide (2) injectionBacterial endotoxin testInterference testGel-clot methodKinetic turbidimetric limulus test