PHYSICOCHEMICAL PROPERTIES, ANALYTICAL DETERMINATIONS AND STABILITY OF EBROTIDINE

Ebrotidine ethyl]amino]methylene]-4-bromo-benzenesulfonamide, CAS 1009 81-43-9, FI-3542) is a new H-2-receptor antagonist with a potent antis ecretory activity and evidenced gastroprotection. This paper describes its physicochemical properties, spectroscopy for its structural ident ification, detection methods for its organic and inorganic impurities, purity quantitation and stressed degradation and stability tests in s olid and solution forms in order to know the behaviour of the test sub stance against certain experimental conditions. The results obtained i ndicate that ebrotidine is stable for over 3 years under normal storag e conditions (25 degrees C/75% RH). As ebrotidine was not found to be hygroscopic or particularly photosensitive, no special storage precaut ions are required.