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METHOD FOR PRODUCING A LIQUID PHARMACEUTICAL PREPARATION
专利权人:
Sanochemia Pharmazeutika AG
发明人:
WELZIG STEFAN,SCHUECKER RAFFAEL,KÄLZ BEATE,GUNGL JÓZSEF,GERDES KLAUS,BRAUNRATH ROSWITHA
申请号:
PL15734058
公开号:
PL3046590T3
申请日:
2015.06.15
申请国别(地区):
PL
年份:
2018
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.
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