三氟甘露糖細(xì)菌內(nèi)毒素檢查方法的研究
發(fā)布時(shí)間:2018-05-27 00:21
本文選題:三氟甘露糖 + 細(xì)菌內(nèi)毒素檢查 ; 參考:《化學(xué)試劑》2017年09期
【摘要】:依照《中國(guó)藥典(2015年版第4部)》1143細(xì)菌內(nèi)毒素檢查法,用不同廠家的鱟試劑對(duì)3批三氟甘露糖進(jìn)行干擾試驗(yàn),建立了三氟甘露糖的細(xì)菌內(nèi)毒素檢查方法。以無(wú)水乙腈溶解三氟甘露糖,當(dāng)用細(xì)菌內(nèi)毒素檢查用水稀釋至濃度不超過(guò)1 mg/m L時(shí),細(xì)菌內(nèi)毒素檢查顯示無(wú)干擾作用。建立的細(xì)菌內(nèi)毒素檢查方法適用于三氟甘露糖,其細(xì)菌內(nèi)毒素限值為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.
【作者單位】: 原子高科股份有限公司;
【分類(lèi)號(hào)】:R927.1
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1 李奇明,金榕兵,唐維佳;高效液相色譜法測(cè)定三氟甘露糖的含量[J];中國(guó)藥業(yè);2004年04期
,本文編號(hào):1939586
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