FIELD: pharmaceuticals.
SUBSTANCE: invention relates to the pharmaceutical industry, namely, to a method for verifying the primary structure of recombinant interferon beta-1b by peptide mapping. Method for verifying the primary structure of recombinant interferon beta-1b by peptide mapping is characterised by separately taking interferon beta-1b and a standard sample thereof, free of protein stabilisers, and simultaneously subjecting to hydrolysis by consecutively adding solutions of the Glu-C endoproteinase enzyme and an acetate buffer, mixing and putting in a thermostat; then a solution of guanidine hydrochloride is added, mixed in, and a dithiothreitol solution added, mixed in and put in a thermostat; the mixture is cooled, subjected to reverse-phase high-performance liquid chromatographic separation with UV detection, obtaining and comparing peptide maps of the primary structure of recombinant interferon beta-1b and a standard sample thereof.
EFFECT: above method is used to effectively verify the authenticity of the primary structure of recombinant interferon beta-1b.
6 cl, 10 dwg, 1 tbl, 8 ex
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Authors
Dates
2022-09-28—Published
2021-09-22—Filed