Physicochemical characterisation of mangafodipir trisodium

Autor: C.E. Sjøgren, E. Couture, K. M. Holm, H. Sivertsen Lunde, Åsmund Larsen, Audun Aukrust, H. Hope, Birgit Tirkkonen, D. Grace, Y. Haile
Rok vydání: 1997
Předmět:
Zdroj: Acta Radiologica. 38:780-789
ISSN: 0284-1851
DOI: 10.3109/02841859709172411
Popis: Purpose: To determine the structure and various physicochemical properties of man-gafodipir (MnDPDP) trisodium, the active ingredient of Teslascan, a new organ-specific contrast medium for MR imaging. Material and Methods: The structure of MnDPDP trisodium crystals was determined by X-ray crystallography. The possible existence of polymorphism in MnDPDP trisodium was evaluated by powder X-ray diffraction, optical microscopy, thermal analysis and IR spectroscopy. In addition, various spectroscopic techniques and physicochemical measurements were used for characterisation of MnDPDP trisodium. Results: The crystallographic data obtained for MnDPDP trisodium show that the general core structure of the MnDPDP anion is similar to that seen in related substances. The metal coordination geometry is a distorted octahedron defined by 2 phenolate oxygens, 2 carboxylate oxygens and 2 amine nitrogens. The unit cell contains 2 MnDPDP anions, 6 sodium ions and 50 water molecules. The various spectroscopic data are consistent with the structure determined by X-ray crystallography. The product (Teslascan) has low viscosity, is isotonic with blood and has a physiological pH. Conclusion: MnDPDP trisodium is a crystalline, hygroscopic solid which is readily soluble in water. No evidence of polymorphism was seen in the samples studied.
Databáze: OpenAIRE