BACKGROUND: During the production process of the X-ray contrast agent iodixanol the drug substance may be exposed to acid, base, air, heat and daylight, conditions that may cause decomposition products. OBJECTIVE: To investigate the chemical stability of iodixanol under accelerating conditions. METHOD: Chemometrical stability studies were undertaken to investigate the effect of acid and base on the contrast agent's stability. RESULTS: Cleavage of the central bridge in iodixanol occurred under ultraviolet irradiation via a Norrish Type-II reaction. Basic conditions (pH 14) combined with heat (60 degrees C) initiated a cyclization reaction. Less than 1% iodixanol decomposed in solution heated to 140 degrees C for 2 days or under both basic conditions (pH 11, 20 degrees C, 5 days) and acidic conditions (pH 0.4, 80 degrees C, 5 days) or under oxygen atmosphere (100 degrees C, 3 days). CONCLUSION: Even under highly acidic and basic conditions, iodixanol is stable.
BACKGROUND: During the production process of the X-ray contrast agent iodixanol the drug substance may be exposed to acid, base, air, heat and daylight, conditions that may cause decomposition products. OBJECTIVE: To investigate the chemical stability of iodixanol under accelerating conditions. METHOD: Chemometrical stability studies were undertaken to investigate the effect of acid and base on the contrast agent's stability. RESULTS: Cleavage of the central bridge in iodixanol occurred under ultraviolet irradiation via a Norrish Type-II reaction. Basic conditions (pH 14) combined with heat (60 degrees C) initiated a cyclization reaction. Less than 1% iodixanol decomposed in solution heated to 140 degrees C for 2 days or under both basic conditions (pH 11, 20 degrees C, 5 days) and acidic conditions (pH 0.4, 80 degrees C, 5 days) or under oxygen atmosphere (100 degrees C, 3 days). CONCLUSION: Even under highly acidic and basic conditions, iodixanol is stable.