Development and validation of a stability-indicating size-indicating size-exclusion LC method for the determination of rhIFN-alpha2a in pharmaceutical formulations

A size-exclusion LC method was validated for the determination of interferon-a2a (rhlFN-alpha2a) in pharmaceutical formulations without interference from human serum albumin. Chromatographic separation was performed on a BioSep-SEC-S 2000 column (300 x 7.8 mm id). The mobile phase consisted of 0.001...

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Veröffentlicht in:	Journal of AOAC International 2013-03, Vol.96 (2), p.324-330
Hauptverfasser:	Zimmermann, Estevan Sonego, da Silva, Lucélia Magalhães, Calegari, Guilherme Zanini, Stamm, Fernanda Pavani, Souto, Ricardo Bizogne, Dalmora, Sérgio Luiz
Format:	Artikel
Sprache:	eng
Schlagworte:	Cell Line, Tumor Chromatography, Liquid - methods Drug Stability Humans Interferon-alpha - chemistry Reproducibility of Results Sensitivity and Specificity
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