| 主权项 |
1. A process for preparing a pure darunavir amorphous form, comprising
a) dissolving darunavir in a first solvent to provide a solution, wherein the first solvent is dichloromethane, ethylene dichloride, chloroform, ethyl acetate, or a mixture thereof; b) distilling the first solvent from the solution obtained in step (a) to provide a residue; c) slurrying the residue obtained in step (b) with second solvent selected from an aliphatic solvent or aromatic solvent, wherein the second solvent does not form a solvate with darunavir, and wherein the second solvent is cyclohexane, hexane, n-heptane, toluene, xylene, or a mixture thereof; and d) isolating pure amorphous darunavir from the slurry in step (c), wherein the pure amorphous darunavir contains less than 5% crystalline polymorphs of darunavir as measured by powder x-ray diffraction. |
