Разработка отраслевого стандартного образца специфической активности эритропоэтина

Based on WHO recommendations and elaborated principles of standardization of erythropoietin (EPO) related drugs, one candidate reference EPO alpha standard has been selected from substances introduced in the Russian State Register of Medicines. The manufacturer’s control tests demonstrated that the selected pharmaceutical substance satisfied the requirements of the regulatory documents. Additional identification testing by capillary zone electrophoresis showed the presence of 8 isoforms, which complies with the European Pharmacopoeia requirements. Conditions were established for the production of a lyophilized form of the industrial reference sample. Certification of the candidate reference sample of EPO was carried out in the course of an inter-laboratory collaboration study. The certified characteristic of specific drug activity was estimated at 2400 IU per ampule, the confidence interval being 94.5 – 105.8%. Evaluation of the proposed reference sample stability allowed the shelf life to be established as 5 years at a storage temperature of -20°C with the possibility of extending the shelf life based on the results of stability monitoring.