Journal of Chromatography & Separation Techniques
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Hermentin p

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• Research Article
  I-Number Assay and Erythropoietin Potency: Retrospective Capillary Zone Electrophoresis Data Analysis of the Biological Reference Preparations of Erythropoietin
  Author(s): Hermentin P* Hermentin P*
  
  The capillary zone electrophoresis data of erythropoietin reference preparations batch 1 (BRP1), batch 2 (BRP2) and batch 3 (BRP3) of three collaborative studies published in 2004, 2007 and 2015 have retrospectively been analyzed by the author via the I-number assay, a physicochemical assay that allows potency calculation of erythropoietin samples in a precise and accurate manner. The results are summarized as follows: The I-number assay revealed an inter-laboratory precision of CV < 1.0% and an accuracy of 100.0 ± < 1.5%. The I-number calculated for an EPO sample and the corresponding EPO reference standard may be regarded analytically “indistinguishable” at I-number differences of < 1.5%, “comparable” at differences of 1.5-3.0% and “different” at differences of >3.0%. This retrospective analysis by the author.. View More»
  DOI: 10.4172/2157-7064.S8-002

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