Physicochemical characterisation of mangafodipir trisodium.
OBJECTIVE
To determine the structure and various physicochemical properties of mangafodipir (MnDPDP) trisodium, the active ingredient of Teslascan, a new-organ-specific contrast medium for MR imaging.


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.


CONCLUSIONS
MnDPDP trisodium is a crystalline, hygroscopic solid which is readily soluble in water. No evidence of polymorphism was seen in the samples studied.
Tirkkonen
B
B
Nycomed Imaging AS, Oslo, Norway. bct@nycomed.com
Aukrust
A
A
Couture
E
E
Grace
D
D
Haile
Y
Y
Holm
K M
KM
Hope
H
H
Larsen
A
A
Lunde
H S
HS
Sjøgren
C E
CE
D055598:Chemical Phenomena; D002627:Chemistry, Physical; D003287:Contrast Media / Q000032:analysis / Q000737:chemistry*; D003460:Crystallization; D018360:Crystallography, X-Ray; D004492:Edetic Acid / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D008345:Manganese / Q000032:analysis / Q000737:chemistry*; D015394:Molecular Structure; D011732:Pyridoxal Phosphate / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D012996:Solutions; D013057:Spectrum Analysis
D003287:Contrast Media; D012996:Solutions; D008345:Manganese; D011732:Pyridoxal Phosphate; D004492:Edetic Acid; C060076:N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid