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Euglobulin-based method for determining the biological activity of defibrotide
专利权人:
Khalid Islam;Terenzio Ignoni;Vijay Kumar
发明人:
Terenzio Ignoni,Vijay Kumar,Khalid Islam
申请号:
US14408272
公开号:
US09902952B2
申请日:
2012.06.22
申请国别(地区):
US
年份:
2018
代理人:
摘要:
It is disclosed a method for determining the biological activity of defibrotide, which comprises the steps of: a) bringing into contact defibrotide, mammalian euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, provides a measurable product; and b) measuring the amount of product formed at successive times, to thereby determine the biological activity of the defibrotide. Liquid defibrotide formulations are also disclosed, preferably water solutions, having a defined biological activity and, in particular, having an activity of 25 to 35 IU/mg of defibrotide, preferably from 27.5 to 32.5 IU/mg and, more preferably, from 28 to 32 IU/mg.
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