公开(公告)号：EP2900262A1

公开(公告)日：2015-08-05

申请号：EP13770475.5

申请日：2013-09-26

申请人： Octapharma AG

发明人： HEGER, Andrea ,  SVAE, Tor-Einar ,  ROEMISCH, Juergen ,  ZOECHLING, Alfred

IPC分类号： A61K39/395 ,  A61K47/00 ,  A61K9/00 ,  G01N33/49

CPC分类号： A61K47/183 ,  A61K39/39591 ,  C07K16/00 ,  C07K16/18 ,  G01N33/49 ,  G01N33/80

摘要： A non-hemolytic acidic composition comprising an immunoglobulin selected from immunoglobulin A, immunoglobulin G or immunoglobulin M at a pH value in the range of 4.65 to 5.7 comprising one or more excipients selected from amino acids, sugars and sugar alcohols in a concentration range of 100-350 mmol/l, in particular 200-350 mmol/l, characterized in that it displays an optical density (OD) in the range of 0.14 to -0.1 when the OD is determined in a spectrophotometer at 414 nm at a film thickness of 0.825 mm; and its use in an assay for determination of the hemolytic potential of intravenously applied pharmaceuticals and compositions and preparations displaying a reduced potential of hemolysis when being applied intravenously.