FIELD: biotechnology.
SUBSTANCE: defibrotide, mammal euglobulin and a substrate specific for the plasmin which, by reaction with the plasmin, gives a measurable product, are brought into contact. The substrate specific for plasmin is a compound of formula A1-A2-A3-X, where A1 and A2 are non-polar amino acids, A3 is lysine or arginine, and X is the measurable product. The measurable product is selected from the group consisting of para-nitroaniline and 2-naphthylamine. The amount of obtained product is measured at successive time points to determine defibrotide biological activity. The invention provides accurate and precise measurement of defibrotide activity even in the presence of impurities such as, for example, RNA, heparin, degraded defibrotide.
EFFECT: sensitive method to detect defibrotide concentrations, and provide good correlation up to the maximum concentration values.
14 cl, 3 dwg, 4 tbl
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Authors
Dates
2017-08-03—Published
2012-06-22—Filed