摘要 |
A process for the production of an amine salt of clavulanic acid and the conversion thereof into a pharmaceutically acceptable salt or ester thereof has been provided. During the crystallisation phase of the amine salt of clavulanic acid either a clavulanic acid containing solution, optionally with a cosolvent, is added to the amine or both reactants are added together to a cristallisation vessel. Also the application of a temperature profile (decreasing in time), profile of speed of addition (increasing in time) and a profile of the ratio amine/clavulanic acid (increasing in time) for this cristallisation process has been provided for. |