摘要
目的:建立硫酸罗通定注射液细菌内毒素检查方法。方法:按《中国药典》2005年版二部附录ⅪE细菌内毒素检查法,对不同生产厂家的样品进行了干扰试验和细菌内毒素检查。结果:本品最大不干扰浓度为0.94 g.L-1。结论:可采用细菌内毒素检查法对硫酸罗通定注射液进行质量控制。
Objectives： To establish a method of bacterial endotoxin test for Rotundine Sulfate Injection. Methods： According to ChP. 2005. Vol Ⅱ ： Appendix XIE, the different samples were used for the investigation of disturb and bacterial endotoxin test. Result： Maximum noninterference concentration of Rotundine Sulfate Injection is 0. 94 g · L^-1. Conclusion： Bacterial endotoxin test could be used to control the quality.
出处
《中国药品标准》
CAS
2009年第6期429-432,共4页
Drug Standards of China
