PROCESS FOR PREPARING {6-[(DIETHYLAMINO)METHYL]NAPHTHALEN-2-YL}METHYL [4-(HYDROXYCARBAMOYL)PHENYL]CARBAMATE HAVING HIGH PURITY

A process for obtaining {{6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4- (hydroxycarbamoyl)phenyl]carbamate and/or pharmaceutically acceptable salts thereof having high purity is described. This process allows to obtain a product having an amount of any single unknown impurity equal to or less t...

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Hauptverfasser: ZENONI MAURIZIO, COCCIOLO STEFANIA, TURCHETTA STEFANO, BERARDI GIORGIO, ULLUCCI ELIO, MAULUCCI NAKIA
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:A process for obtaining {{6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4- (hydroxycarbamoyl)phenyl]carbamate and/or pharmaceutically acceptable salts thereof having high purity is described. This process allows to obtain a product having an amount of any single unknown impurity equal to or less than 0.10%, as well as a product having a purity greater than 99.5%, preferably equal to or greater than 99.6%. An HPLC method for determining the purity of the product and possible impurities thereof is also described. 描述了一种获得高纯度[4-(羟基氨基甲酰基)苯基]氨基甲酸{6-[(二乙基氨基)甲基]萘-2-基}甲酯和/或其药学上可接受的盐的方法。该方法能够获得任何单一未知杂质的量等于或小于0.10%的产品,以及纯度大于99.5%,优选等于或大于99.6%的产品。还描述了一种用于测定产物的纯度及其可能的杂质的HPLC方法。