600994 There is disclosed crystalline darunavir hydrate free of any non-aqueous solvent. Also disclosed is a process for preparing darunavir hydrate according to any one of claims 1 to 6comprising reacting 1-([[(3R,3aS,6aR)hexahydrofuro[2,3-b]furan-3-yloxy]carbonyl]oxy)-2,5-pyrrolidinedione with 4-amino-N-(3-amino-2-hydroxy-4-phenylbutyl)-N-isobutylbenzenesulfonamide to obtain a residue； stirring the residue in a mixture of water miscible solvent and water and drying the solid to obtain crystalline darunavir hydrate, a process for preparing darunavir hydrate comprising stirring darunavir, having at least one non-aqueous solvent in the crystal lattice, in a mixture of water miscible solvent and water； then filtering the mixture to obtain a solid then stirring the solid in water； filtering the solid/water mixture and drying to obtain crystalline darunavir hydrate, along with its use in treatment of HIV and in the manufacture of amorphous darunavir.
