Potency Evaluation of Recombinant Human Erythropoietin in Brazil: Assessment of Reproducibility Using a Practical Approach

In this study, we compared the results of potency determination of recombinant human erythropoietin (rhEPO) obtained between 2010 and 2012 by the National Institute of Quality Control in Health (INCQS/Fiocruz), i.e., the National Control Laboratory (NCL), and by a manufacturer of rhEPO. In total, 47 different batches of commercially prepared rhEPO (alpha isoform) were analyzed. All results, including those of the control and warning limits, remained within the limits recommended by European Pharmacopoeia (Ph. Eur.). All relative error (RE) values were less than ± 30%, wh ereas most were appro...