Drug master file preperation of the active substance naproxen sodium marketed in our country

This study aims to prepare ?Drug Master File? (DMF) that is required for drug approval application. For this purpose, the active ingredient ?naproksen sodium? originating from China Market was chosen.Primarily, Infrared Spectroscopy, Nuclear Magnetic Resonance Spectroscopy, Ultraviolet Spectroscopy, Mass Spectroscopy, Differential Scanning Calorimetry, X-Ray Diffraction, Thermo-Gravimetric Analysis and Elemental Analysis methods were applied to the determination of the structure of the active ingredient.Then, high-pressure liquid chromatography, gas chromatography and atomic absorption methods were applied to determine of the residue solvents, organic and inorganic impurities of the active ingredient.Additionally, the conformity of the active substance is detected according to the experiments performed as in the active substance monograph in European and U.S pharmacopoeia.Finally, active ingredient stability studies are conducted according to the stability test guideline of ICH for the new drug substances and products.According to the results obtained in the studies, the active substance showed the structure of naproksen sodium and is of similar properties with naproksen sodium monograph in the European and American Pharmacopeia. Thus, the active substance has been proved to be safely used in the production stages of proprietary medicines.Key Words: Drug Master File, Naproxen sodium, Analysis, Pharmacopoeia