[EN] PROCESS FOR THE PREPARATION OF 2,2',2''-(10-((2R,3S)-1,3,4-TRIHYDROXY BUTAN-2-YL)-1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIYL) TRIACETIC ACID AND ITS COMPLEXES<br/>[FR] PROCÉDÉ DE PRÉPARATION D'ACIDE 2,2',2''-(10-((2R,3S)-1,3,4-TRIHYDROXY BUTAN-2-YL)-1,4,7,10-TÉTRAAZACYCLODODÉCANE-1,4,7-TRIYL) TRIACÉTIQUE ET DE SES COMPLEXES
申请人:BIOPHORE INDIA PHARMACEUTICALS PVT LTD
公开号:WO2020012372A1
公开(公告)日:2020-01-16
The present invention relates to an improved process for the preparation of 2,2',2''-(10-((2R,3S)-1,3,4-trihydroxy butan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4,7-triyl) triacetic acid, gadolinium (III) with iron metal content less than 5 ppm and free gadolinium content less than 10 ppm, which is represented by the formula (1). The present invention further relates to an improved process for the preparation of calcium complex of 10-(2,3-Dihydroxy-1-(hydroxymethyl)propyl)-1,4,7,10-tetraazacyclo decane-1,4,7-triacetic acid known as Calcobutrol (1a) and its sodium salt of formula (1b) with purity greater than 98.0 %.
本发明涉及一种改进的制备过程,用于制备2,2',2''-(10-((2R,3S)-1,3,4-三羟基丁醇-2-基)-1,4,7,10-四氮杂十二环-1,4,7-三基) 三乙酸,其中钆(III)的铁含量小于5 ppm,自由钆含量小于10 ppm,该化合物由式(1)表示。本发明还涉及一种改进的制备过程,用于制备10-(2,3-二羟基-1-(羟甲基)丙基)-1,4,7,10-四氮杂环己烷-1,4,7-三乙酸的钙络合物,也称为Calcobutrol(1a),以及其纯度大于98.0%的钠盐,其化学式为(1b)。