摘要
目的修订注射用盐酸大观霉素细菌内毒素检查法质量标准。方法按《中国药典》2005年版二部,修改本品细菌内毒素限值,并研究注射用盐酸大观霉素对细菌内毒素检查试验的干扰情况。结果3.333mg.mL-1的供试品稀释液对试验无干扰作用。结论本品可采用细菌内毒素检查法,并修订了本品细菌内毒素检查法质量标准。
Objective To revise the criterion for bacterial endotoxins test of Spectinomycin Hydrochloride for Injection.Methods The limit for bacterial endotoxins in this product was designed according to CP2005,and inhibition or enhancement test for bacterial endotoxins test was done.Results Spectinomycin Hydrochloride for Injection neither inhibit nor enhance the test at the concentration of 3.333mg·mL^-1.Conclusion This product is suitable for bacterial endotoxins test and the bacterial endotoxins test method for this product is revised.
出处
《中国药事》
CAS
2010年第1期92-93,96,共3页
Chinese Pharmaceutical Affairs
关键词
注射用盐酸大观霉素
细菌内毒素检查
干扰试验
Spectinomycin Hydrochloride for Injection
bacterial endotoxins test
inhibition or enhancement test
