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公开(公告)号:US09097692B2
公开(公告)日:2015-08-04
申请号:US13249997
申请日:2011-09-30
申请人: Frank Milek , Rouven Josl
发明人: Frank Milek , Rouven Josl
CPC分类号: G01N30/06 , G01N30/34 , G01N30/74 , G01N2030/8872 , Y10T436/200833 , Y10T436/202499
摘要: The invention relates to a method for quantitatively determining impurities in the form of aldehydes and ketones in glycerin serving for preparing pharmaceuticals, in which the glycerin containing impurities is reacted with a derivatization reagent in a sample solution and the quantity of derivatized impurities is determined. Said method is characterized in that PFBHA, O-(2,3,4,5,6-pentafluorobenzyl)-hydroxylamine hydrochloride, is used as the derivatization reagent, the derivatizing is conducted in the presence of a solubilizer in the form of a polar organic solvent, and liquid chromatographic separation and UV detection are performed. A subject matter of the invention is also the use of glycerin, in which the content of impurities of 9 ppm or less has been determined by means of the described method in a pharmaceutical preparation. According to the invention, impurities in glycerin can be better determined.
摘要翻译: 本发明涉及一种用于定量测定用于制备药物的甘油中醛和酮形式的杂质的方法,其中含有杂质的甘油与样品溶液中的衍生试剂反应,并测定衍生化杂质的量。 所述方法的特征在于使用PFBHA,O-(2,3,4,5,6-五氟苄基) - 羟胺盐酸盐作为衍生试剂,衍生化在极性形式的增溶剂存在下进行 有机溶剂,液相色谱分离和UV检测。 本发明的主题也是在药物制剂中通过所述方法测定了9ppm以下的杂质含量的甘油的用途。 根据本发明,可以更好地测定甘油中的杂质。