公开(公告)号：US20170007726A1

公开(公告)日：2017-01-12

申请号：US15116263

申请日：2015-02-02

申请人： Agfa HealthCare NV

发明人： Diederik BUFFEL ,  Xavier BOI ,  Judith PYPE

IPC分类号： A61K49/10 ,  B01D61/02 ,  A61K47/18 ,  C07D295/15 ,  C07F5/00

CPC分类号： A61K49/108 ,  A61K47/18 ,  B01D61/027 ,  B01D2311/2649 ,  B01D2311/2673 ,  B01D2315/16 ,  C07D257/02 ,  C07D295/15 ,  C07F5/003

摘要： A process for purifying a compound of formula 1, includes the following steps: a) adding an acid to an aqueous solution of the compound of formula 1, including salts and hydrates thereof so as to obtain a slurry having a pH≦3; and b) filtering the slurry and at least one time washing the obtained precipitate with a liquid comprising water; and c) dissolving the precipitate obtained in step b) in water to obtain an aqueous solution; and d) filtering of the solution obtained in step c) over a nanofiltration membrane having a Molecular Weight Cut Off in the range from 150 to 500 and wherein optionally, between step c) and step d) the pH of the aqueous solution is adjusted to a pH value in the pH range as specified by the manufacturer of the nanofiltration membrane. A process for preparing a gadolinium complex of the purified compound of formula 1 is also disclosed. This gadolinium complex can be used for making a pharmaceutical composition as a contrast agent for magnetic resonance imaging.

摘要翻译： 包括以下步骤：a）向式1化合物的水溶液中加入酸，包括其盐和水合物，以获得pH≤3的浆料; 和b）过滤浆料，并至少一次用包含水的液体洗涤所获得的沉淀物; 和c）将步骤b）中获得的沉淀溶解在水中以获得水溶液; 以及d）将步骤c）中获得的溶液过滤到分子量截留在150-500范围内的纳滤膜中，并且其中任选地在步骤c）和步骤d）之间，将水溶液的pH调节至 在纳米过滤膜制造商规定的pH范围内的pH值。 还公开了制备纯化的式1化合物的钆络合物的方法。 该钆络合物可用于制备用作磁共振成像的造影剂的药物组合物。