摘要
目的确定注射用乙酰谷酰胺的细菌内毒素限值并进行干扰试验测定。方法建立注射用乙酰谷酰胺的细菌内毒素检查法。结果当注射用乙酰谷酰胺稀释至1g·L-1时,用标示灵敏度为2.5×10-4Eu·L-1的鲎试剂进行细菌内毒素检查是有效的。结论鲎试剂可用于注射用乙酰谷酰胺的细菌内毒素检查。
Aim To establish a bacterial endotoxin testing method for Aceglutamide for Injection was established. Methods The limit of endotoxin was determined and validated by interference test. Results The experiment showed that the interference elements could be excluded by diluting Aceglutamide for injection to 1 g · L^-1 ,and it was effective that the bacterial endotoxin could be tested by amebocyte lysate with accuracy of 2.5 × 10^-4 Eu · L^- 1. Conclusion The bacterial endotoxin testing method can be used for Aceglutamide for Injection.
出处
《安徽医药》
CAS
2007年第1期37-38,共2页
Anhui Medical and Pharmaceutical Journal
关键词
注射用乙酰谷酰胺
细菌内毒素检查
干扰试验
aceglutamide for injection
bacterial endotoxin test
interference test
