Method for preparing high-purity [4-(hydroxycarbamoyl) phenyl] carbamic acid {6-[(diethylamino) methyl] naphthalene-2-yl} methyl ester

• Main Authors: TURCHETTA, SIMONE, COCCIOLO STEFANO, BERARDI GIOVANNI, MALUCCI, NADIA, ULUCCI EMILIO, ZENONI MASSIMO
• Format: Patent
• Language: Chinese; English
• Published: 27.10.2023
• Subjects: ACYCLIC OR CARBOCYCLIC COMPOUNDS; CHEMISTRY; HUMAN NECESSITIES; HYGIENE; INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; MEDICAL OR VETERINARY SCIENCE; METALLURGY; ORGANIC CHEMISTRY; PHYSICS; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS; TESTING

The invention relates to a method for preparing high-purity [4-(hydroxycarbamoyl) phenyl] carbamic acid {6-[(diethylamino) methyl] naphthalene-2-yl} methyl ester. A method for obtaining high-purity [4-(hydroxycarbamoyl) phenyl] carbamic acid {6-[(diethylamino) methyl] naphthalene-2-yl} methyl ester and/or a pharmaceutically acceptable salt thereof is described. The method can obtain a product with the amount of any single unknown impurity equal to or less than 0.10%, and a product with the purity greater than 99.5%, preferably equal to or greater than 99.6%. Also described is an HPLC method for determining the purity of a product and possible impurities thereof. 本发明涉及制备高纯度[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}甲酯的方法，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。