rHu IFN alpha 2b

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Recombinant Human Interferon alpha 2B

Concentrated Solution

Formulation: rHu Interferon alpha 2b, Sodium Acetate 25 mM, Sodium chloride 315 mM; pH 4.2-4.8.

Purity and Identification: SDS-PAGE(reducing and non-reducing): Not more than 3% contaminants, no single contaminant more than 1%.
Peptide Mapping and Isoelectric Focusing determinations with respect to the reference standard Interferon alfa 2b CRS (EDQM)

HPLC: principal peak >95%, no other peak >3%.

Western blot specific antibody identification.

Absence of specific contaminants from host cell derived proteins: less than 50 ppm; and host cell derived DNA (dot blot hybridization): less than 100 pg per 128 ug of protein. Technical Report Series N°747-WHO.

Sterility Test: USP XXVIII

Safety Test: USPXXVIII

Endotoxin level: <100 EU per mg of protein. (LAL Test).

Biological Activity: Determined according to a cytopathic effect inhibition assay with MDBK cells infected with vesicular stomatitis virus. (Rubinstein S, et al J.Virol.(1981) 37: 755-758, and Pestka S ed. Methods in Enzymology, Vol 78, Academic Press New York, 387-394)

Specific activity: Not less than 140 MIU per mg of protein, according to lot #.

Molecular Mass: 19,400 Da

Source: E. coli

For research use only. Not for use in diagnostics or therapeutic procedures.