摘要
目的建立氟哌利多注射液的细菌内毒素检查法。方法按2005年版《中国药典》细菌内毒素检查法相关规定进行试验。结果该制剂在17μg/mL浓度下对细菌内毒素检查无干扰作用。结论所建立的氟哌利多注射液的细菌内毒素检查方法具有可行性,其内毒素限值可定为30EU/mg。
Objective To establish a bacterial endotoxin method for droperidol injection.Methods According to the method in the appendix of the Chinese Pharmacopoeia（edition 2005）,the bacterial endotoxin test was carried out.Results The preparation did not interfere with endotoxin test below the concentration of 17μg/mL.Conclusion The method of bacterial endotoxin test is feasible with the limit of 30 EU/mg for roperidol injection.
出处
《中国医药指南》
2010年第20期62-64,共3页
Guide of China Medicine
