abstract |
This invention relates to a process for the preparation of a liquid formulation comprising a complex of lanthanide macrocyclic chelates and a mol / mol amount of free macrocyclic chelate between 0.002% and 0.4%, preferably between 0.02% and 0.3. % and more preferably between 0.025% and 0.25%, with the macrocyclic chelate being advantageously selected from DOTA, NOTA, DOTAGA, DO3A, BT-DO3A, HP-DO3A and PCTA, and preferably DOTA, with said the procedure consisting of the following successive steps: (b) the preparation of a liquid; a pharmaceutical composition comprising, initially, the complex of the lanthanide macrocyclic chelate and, secondly, the free macrocyclic chelate and / or free lanthanum; d) adjusting C chl and / or C lanl to give C chl = C tchl and Clanl = 0, where C t chl is the target concentration of the free macrocyclic of chelate in the final liquid formulation. |