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Hermentin P
Hermentin P
Feuerdornweg 8, 35041 Marburg
Germany
Publications
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Research Article
Ibio Number Assay and Erythropoietin Bioactivity: Comparison of the Calculated and the Stated Potencies of the Biological Reference Preparations of Erythropoietin
Author(s): Hermentin PHermentin P
The potencies of the biological reference preparations of erythropoietin, assigned by the European Pharmacopoeia Commission on the basis of the normocythaemic and polycythaemic mouse bioassay for erythropoietin, have retrospectively been calculated by the author via the Ibio-number assay, a physicochemical assay based on capillary zone electrophoresis data that allows to calculate the potency of erythropoietin medicinal products. The retrospective analysis by the author of the capillary electrophoresis data of three collaborative studies published in 2004, 2007 and 2015 has revealed that the potencies assigned for erythropoietin reference preparations batch 1 and batch 2 (~130.0 IU/μg, each) have been stated ~5 % too low respectively ~10 % too low, whereas the potency stated for erythropoietin reference preparation batch 3 (~141.1 IU/μg) was confirmed (difference to the stated p.. View More»
DOI: 10.4172/2153-2435.1000542