INJECTABLE PHARMACEUTICAL FORMULATION OF MELPHALAN

摘要

An injectable pharmaceutical formulation of Melphalan comprising a solid composition of melphalan hydrochloride lyophilized with a content of impurities up to 1.3 % (p/p)and a pH buffer solution; a process to prepare said solid composition. Also a reconstituted solution of melphalan comprising a solid composition of melphalan lyophilized reconstituted wherein said solution is aqueous, a perfusion free of organic solvent and a kit.