Physicochemical properties, analytical determinations and stability of ebrotidine.
Ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl] thio]ethyl]amino]methylene]-4-bromo-benzenesulfonamide, CAS 100981-43-9, FI-3542) is a new H2-receptor antagonist with a potent antisecretory activity and evidenced gastroprotection. This paper describes its physicochemical properties, spectroscopy for its structural identification, detection methods for its organic and inorganic impurities, purity quantitation and stressed degradation and stability tests in solid and solution forms in order to know the behaviour of the test substance against certain experimental conditions. The results obtained indicate that ebrotidine is stable for over 3 years normal storage conditions (25 degrees C/75% RH). As ebrotidine was not found to be hygroscopic or particularly photosensitive, no special storage precautions are required.
Albet
C
C
Centro de Investigación Farmacéutica Grupo Ferrer, Barcelona, Spain.
Fernández
J M
JM
Castelló
J M
JM
Sacristán
A
A
Ortiz
J A
JA
D001557:Benzenesulfonates / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D006635:Histamine H2 Antagonists / Q000737:chemistry*; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D011199:Potentiometry; D013056:Spectrophotometry, Ultraviolet; D017550:Spectroscopy, Fourier Transform Infrared; D013844:Thiazoles / Q000737:chemistry*; D014961:X-Ray Diffraction
D001557:Benzenesulfonates; D006635:Histamine H2 Antagonists; D013844:Thiazoles; C075156:ebrotidine