Stefan WELZIG,Raffael SCHUECKER,Beate KAELZ,Jozsef GUNGL,Klaus GERDES,Roswitha BRAUNRATH
申请号：
US15500685
公开号：
US20170216462A1
申请日:
2015.06.15
申请国别(地区):
US
年份:
2017
代理人:
摘要：
A method for producing a liquid pharmaceutical preparation which contains a complex consisting of DOTA and gadolinium and a base such as L-lysine or meglumine, includes the following steps: a) An aqueous solution containing free DOTA, free gadolinium and a base such as L-lysine or meglumine is produced. b) The yield of free DOTA and free gadolinium is determined in the solution obtained according to step a). c) Free gadolinium and/or free DOTA is added in order to adjust a stoichiometric excess of free DOTA in the solution. d) The complexation is executed at an increased temperature. e) Additional base such as L-lysine or meglumine is added in order to adjust the pH value. f) The final volume of the preparation is adjusted.
