| 摘要 |
The invention concerns a process for the preparation of the calcium complex of 10-(2,3-dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclodecane-1,4,7-triacetic acid (calcobutrol), wherein: a) the gadolinium complex of 10-(2,3-dihydroxy-l-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclodecane-l,4,7-triacetic acid (gadobutrol) is decomplexed with a decomplexing agent at 75 to 100°C forming a precipitated gadolinium salt, b) the precipitated gadolinium salt is removed, c) the solution resulting from step b) is bound to an acidic ion exchange resin at pH 3.65-3.80 sorbing ligand, d) said ligand is eluted with an aqueous alkaline solution, e) the eluate is treated with acidic ion exchange resin, obtaining the solution comprising ligand, and f) the ligand is complexed with Caions at 75 to 100°C and crystallised the obtained complex. The invention furthermore concerns calcobutrol with a hitherto unknown level of purity. |
