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AssigneeItalfarmaco S.p.A.
InventorsStefano TURCHETTA, Maurizio ZENONI, Elio ULLUCCI, Stefania COCCIOLO, Giorgio BERARDI, Nakia MAULUCCI
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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.
1-23. (canceled)
A process for preparing 6-((diethylamino)methyl)naphthalen-2-yl}methyl(4-(hydroxycarbamoyl)phenyl]carbamate and/or a pharmaceutically acceptable salt thereof having an amount of any single unknown impurity equal to or lower than 0.10%, said process comprising the steps of:
{6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate or a pharmaceutically acceptable salt thereof, having an amount of any single unknown impurity equal to or lower than 0.10% or having an amount of any single impurity other than intermediate (I) or amide (Ia) equal to or lower than 0.15%.
{6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate or a pharmaceutically acceptable salt thereof, having a purity greater than 99.5%.
A method for determining the purity of a product {6-[(diethylamino)methyl]naphthalen-2-yl}methyl(4-(hydroxycarbamoyl)phenyl]carbamate or a pharmaceutically acceptable salt thereof, comprising elution of the product through an HPLC column having a stationary phase containing alkyl chains, and subsequent detection of the product itself and the impurities thereof by means of a detector, including a detector of UV, MS or RID type.
Dependencies are inferred from the claim text.