摘要
目的建立注射用葡醛酸钠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。结果该制剂对细菌内毒素检查无干扰作用。结论所建立的注射用葡醛酸钠细菌内毒素检查方法具有可行性,其细菌内毒素限值可定为0.5EU/mg。
Objective To establish a bacterial endotoxin method for sodium glucuronic acid for 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. Conclusion The method of bacterial endotoxin test is feasible with the limit of 0. 5 EU/mg for sodium glucuronic acid for injection.
出处
《中国药业》
CAS
2008年第7期32-33,共2页
China Pharmaceuticals
关键词
注射用葡醛酸钠
细菌内毒素检查
质量控制
sodium glucuronie acid for injection
bacterial endotaxins test
quality control
