Evaluation of branch reference standard of leucocyte interferon alpha activity
The article provides data on evaluation of the branch reference standard (BRS) of leucocyte interferon alpha, intended for assessment of interferon batches by their specific activity. The candidate material was confirmed to comply with specifications, outlined in the manufacturer’s pharmacopoeial monograph ФСП ЛС-001078-130711 («Description», «Identification», «Solubility», «Clarity of the solution», «Colority of the solution», «pH», «Loss on drying», «Protein content», «Sterility», «Abnormal toxicity», «Specific safety», «Specific activity», «Ovalbumin», «Hepatitis B virus surface antigen», «Antibodies for HIV-1 and HIV-2», «Antibodies for Hepatitis C virus»). Specific activity of the candidate material was established against the International Reference Standard Interferon alpha Human 94/784. The study showed, that specific activity of BRS was 6000-13600 IE/ml with 95% confidence. The expiration date of leucocyte interferon alpha BRS is based on the corresponding product’s shelf-life and is equal to 2 years. Introduction of the certified leucocyte interferon alpha activity BRS will allow to assess of the quality of all domestic interferon preparations (non-synthetic) by performing specific activity testing at an appropriate scientific and technological level, and increase the quality of tests carried out both for certification and marketing authorization purposes.