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Stability of the X‐ray contrast agent iodixanol=3,3′,5,5′‐tetrakis(2,3‐dihydroxypropylcarbamoyl)‐2,2′,4,4′,6,6′‐hexaiodo‐N,N′‐(2‐hydroxypropane‐1,3‐diyl)‐diacetanilide towards acid, base, oxygen, heat and light
Author(s) -
Priebe H.,
Aukrust A.,
Bjørsvik H. R.,
Tønseth C. P.,
Wiggen U. N.
Publication year - 1999
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1046/j.1365-2710.1999.00225.x
Subject(s) - iodixanol , chemistry , chemical stability , chromatography , contrast medium , organic chemistry , radiology , medicine
Summary 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 °C) initiated a cyclization reaction. Less than 1% iodixanol decomposed in solution heated to 140 °C for 2 days or under both basic conditions (pH 11, 20 °C, 5 days) and acidic conditions (pH 0·4, 80 °C, 5 days) or under oxygen atmosphere (100 °C, 3 days). Conclusion: Even under highly acidic and basic conditions, iodixanol is stable.