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Pure vancomycin hydrochloride

机译:纯盐酸万古霉素

摘要

The new pure vancomycin hydrochloride substantially free of impurities known in commercially available products is described. The term "substantially free of impurities" designates a purity of vancomycin hydrochloride between about 97% and about 99%, particularly between about 98% and about 99%, preferably about 99%, as determined by HPLC analytical method as directed in U.S.P., NF 27th revision, 22 (2004). The new pure vancomycin hydrochloride (vancomycin B hydrochloride) contains less than 0.7% of total impurities, namely, only one impurity exceeds 0.3%. The new process for the purification of crude vancomycin by displacement chromatography is described by which the desired pure antibiotic according to the present invention is produced, based on the finding that high purity of the vancomycin hydrochloride is obtained using low selected pH values of the mobile phase between 3.9 and 4.2. Vancomycin hydrochloride is the known antibiotic which is used for the treatment of severe staphylococcal infections, especially those caused by methicillin-resistant staphylococcal strains.
机译:描述了基本上无市售产品中已知的杂质的新的纯万古霉素盐酸盐。术语“基本上不含杂质”表​​示盐酸万古霉素的纯度为约97%至约99%,特别是约98%至约99%,优选为约99%,这是按照美国药典(NF)中所述的HPLC分析方法测定的。 27修订,22(2004)。新的纯净万古霉素盐酸盐(万古霉素B盐酸盐)所含杂质总量不到0.7%,即,只有一种杂质含量超过0.3%。描述了通过置换色谱法提纯粗制万古霉素的新方法,根据该发现,使用低选择的流动相pH值可获得高纯度的万古霉素盐酸盐,从而可以生产出本发明所需的纯抗生素在3.9和4.2之间。盐酸万古霉素是已知的抗生素,其用于治疗严重的葡萄球菌感染,尤其是由耐甲氧西林的葡萄球菌菌株引起的感染。

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