摘要
目的探讨注射用尿多酸肽的细菌内毒素检查方法。方法按2010年版《中国药典(二部)》细菌内毒素检查法进行试验。结果注射用尿多酸肽稀释至质量浓度为1.67 g/L时可消除干扰,其细菌内毒素限值L为0.15 EU/mg。结论可采用细菌内毒素检查法对注射用尿多酸肽进行细菌内毒素检查。
Objective To establish the inspection method of bacterial endotoxin in uroacitides for injection.Methods The experiment was implemented according to the endotoxin inspection in Chinese Pharmacopoeia（edition 2010,vol.Ⅱ）.Results Uroacitides for injection was diluted to 1.67 g/L,interference could be eliminated.The bacterial endotoxin limit was 0.15 EU/mg.Conclusion The endotoxin inspection method can be used for performing the bacterial endotoxin inspection of uroacitides for injection.
出处
《中国药业》
CAS
2012年第16期41-42,共2页
China Pharmaceuticals
关键词
注射用尿多酸肽
细菌内毒素
鲎试剂
uroacitides for injection
bacterial endotoxin
tachypleus amebocyte lysate
