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.
一种
美法仑注射药物制剂,包括
盐酸美法仑冻干固体组合物,杂质含量不超过1.3%(p/p)和pH缓冲溶液;制备所述固体组合物的工艺。还有一种
美法仑的
重组溶液,包括
美法仑冻干
重组的固体组合物,其中所述溶液为
水溶液,一种不含有机溶剂的灌流液和一种试剂盒。