Theoretical rationale for the choice of interferon alfa-2b substance to be certified as a reference standard for identification test by peptide mapping

The article provides with the results of theoretical research on justification of the choice of methionine form of recombinant interferon alfa-2b substance to be certified as a reference standard for identification test by peptide mapping. At present non- methionine and methionine forms of interferon alfa-2b substance are produced in Russia. The reference standard of interferon alfa-2b CRS I0320301, recommended by the European Pharmacopoeia, is a non- methionine standard and is suitable for identification test by peptide mapping only for a non- methionine form of a protein. In order to choose the reference standard candidate for methionine form of interferon alfa-2b, the article provides with the comparative analysis of the range of criteria and methods used by domestic manufacturers to confirm the quality of substances, authorized in the Russian Federation. The theoretical research allowed to choose interferon alfa-2b substance as a reference standard candidate for identification test by peptide mapping.