FIELD: chemistry.
SUBSTANCE: there is provided dry composition of factor XIII obtained by lyophilizing an aqueous composition containing factor XIII, a salt and histidine, wherein the salt is sodium chloride and its concentration in the aqueous composition is in the range of 25-50 mM, and factor XIII is the recombinant factor XIII. A method of preparing a dry composition and method for stabilizing a composition of factor XIII during storage in a dried form so that the level of activated nonproteolytic by factor XIII, measured immediately after the dissolution was not more than 1% of the total content of factor XIII, is carried out by lyophilization of the above aqueous composition. The use of the group of inventions provides a stable preparation of lyophilized factor XIII containing a reduced amount of degradation products of factor XIII, in particular, non-thiolytically activated XIII (rFXIIIa0) - no more than 1% of the total content of factor XIII.
EFFECT: improved stability.
5 cl, 3 dwg, 9 tbl, 4 ex
Authors
Dates
2017-04-18—Published
2009-04-20—Filed