Determination of pegfilgrastim aggregates by size-exclusion high-performance liquid chromatography on a methacrylate-based column

A size-exclusion high-performance liquid chromatographic method using a methacrylate-based column was developed, validated and implemented for the determination of pegfilgrastim aggregates. The samples were directly injected into a TSKgel G4000PWXL column (7.5 mm × 300 mm, 10 μm,

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Bibliographische Detailangaben
Veröffentlicht in:	Biologicals 2017-03, Vol.46, p.153-158
Hauptverfasser:	Shahbazi, Majid, Tamaskany Zahedy, Elnaz, Kiumarsi, Shiva, Hadi Soltanabad, Mojtaba, Shahbazi Azar, Saleh, Amini, Hossein
Format:	Artikel
Sprache:	eng
Schlagworte:	Aggregation Chromatography, Gel - instrumentation Chromatography, Gel - methods Chromatography, High Pressure Liquid - instrumentation Chromatography, High Pressure Liquid - methods Filgrastim Granulocyte Colony-Stimulating Factor - analysis Granulocyte Colony-Stimulating Factor - chemistry Methacrylate-based column Methacrylates - chemistry Molecular Weight Pegfilgrastim PEGylation Polyethylene Glycols Recombinant Proteins - analysis Recombinant Proteins - chemistry Reproducibility of Results Size-exclusion HPLC Temperature
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Beschreibung
Zusammenfassung:	A size-exclusion high-performance liquid chromatographic method using a methacrylate-based column was developed, validated and implemented for the determination of pegfilgrastim aggregates. The samples were directly injected into a TSKgel G4000PWXL column (7.5 mm × 300 mm, 10 μm,
ISSN:	1045-1056 1095-8320
DOI:	10.1016/j.biologicals.2017.02.003