Desalination of a composition comprising a contrast agent

摘要

The invention relates to industrial preparation of contrast agents, and further to an improved process for the purification of contrast agents. In particular, it relates to a process for reducing the salt content of compositions comprising an MR contrast agent or an X-ray contrast agent, such as a non-ionic iodinated monomeric compound or a non-ionic iodinated dimeric compound.

主权项

1. A process for purifying a first composition comprising (i) a contrast agent selected from the group consisting of iohexol, iodixanol, ioforminol, and a magnetic resonance (MR) contrast agent, and (ii) at least one salt, the process comprising:
desalinating the first composition by electrodeionization (EDI), using a wafer-based EDI device, to yield a second composition including the contrast agent and a first reduced concentration of the at least one salt; performing one of purifying and desalinating the second composition using electrodialysis (ED) to yield a third composition including the contrast agent and a second reduced concentration of the at least one salt; crystallizing the third composition to yield a crystallized third composition including a crystallized contrast agent and the at least one salt; dissolving the crystallized third composition in a solvent to yield a fourth composition; and purifying the fourth composition to further reduce a concentration of the at least one salt in the fourth composition.