三氟甘露糖细菌内毒素检查方法的研究

发布时间：2018-05-27 00:21

本文选题：三氟甘露糖 + 细菌内毒素检查　；参考：《化学试剂》2017年09期

【摘要】：依照《中国药典(2015年版第4部)》1143细菌内毒素检查法,用不同厂家的鲎试剂对3批三氟甘露糖进行干扰试验,建立了三氟甘露糖的细菌内毒素检查方法。以无水乙腈溶解三氟甘露糖,当用细菌内毒素检查用水稀释至浓度不超过1 mg/m L时,细菌内毒素检查显示无干扰作用。建立的细菌内毒素检查方法适用于三氟甘露糖,其细菌内毒素限值为1 EU/mg。
[Abstract]:According to the Chinese Pharmacopoeia (Chinese Pharmacopoeia, part 4, 2015) > 1143 bacterial endotoxin test method, three batches of trifluoromannan were tested with Limulus reagent from different manufacturers, and the bacterial endotoxin test method of trifluormannose was established. Dissolving trifluoromannose with anhydrous acetonitrile, the bacterial endotoxin test showed no interference when the concentration was not more than 1 mg/m / L when the bacterial endotoxin test was diluted with water. The established bacterial endotoxin test method is suitable for trifluoromethyl mannose with a bacterial endotoxin limit of 1 EUP / mg.
【作者单位】：原子高科股份有限公司;
【分类号】：R927.1

【相似文献】