prikaz prve stranice dokumenta Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis
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Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis
ELECTROPHORESIS, 35 (2014), 18; 2608-2614. https://doi.org/10.1002/elps.201300552
Benković, Goran; Škrlin, Ana; Madić, Tomislav; Debeljak, Željko; Medić-Šarić, Marica

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Benković, G., Škrlin, A., Madić, T., Debeljak, Ž. i Medić Šarić, M. (2014). Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis. ELECTROPHORESIS, 35. (18), 2608-2614. doi: 10.1002/elps.201300552

Benković, Goran, et al. "Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis." ELECTROPHORESIS, vol. 35, br. 18, 2014, str. 2608-2614. https://doi.org/10.1002/elps.201300552

Benković, Goran, Ana Škrlin, Tomislav Madić, Željko Debeljak i Marica Medić Šarić. "Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis." ELECTROPHORESIS 35, br. 18 (2014): 2608-2614. https://doi.org/10.1002/elps.201300552

Benković, G., et al. (2014) 'Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis', ELECTROPHORESIS, 35(18), str. 2608-2614. doi: 10.1002/elps.201300552

Benković G, Škrlin A, Madić T, Debeljak Ž, Medić Šarić M. Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis. ELECTROPHORESIS [Internet]. 2014. [pristupljeno 17.11.2024.];35(18):2608-2614. doi: 10.1002/elps.201300552

G. Benković, A. Škrlin, T. Madić, Ž. Debeljak i M. Medić Šarić, "Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis", ELECTROPHORESIS, vol. 35, br. 18, str. 2608-2614, 2014. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:239:631162. [Citirano: 17.11.2024.]

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Naslov (engleski)Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis
AutorGoran Benković
AutorAna Škrlin
AutorTomislav Madić
AutorŽeljko Debeljak
MBZ: 296571
AutorMarica Medić-Šarić
MBZ: 74265
Autorova ustanovaSveučilište u Zagrebu
Farmaceutsko-biokemijski fakultet
Znanstveno / umjetničko
područje, polje i grana		PRIRODNE ZNANOSTI
Biologija
Biokemija i molekularna biologija
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Temeljne medicinske znanosti
Farmakologija
Sažetak (engleski)
Current methods for determination of impurities with different charge-to-volume ratio are limited especially in terms of sensitivity and precision. The main goal of this research was to establish a quantitative method for determination of impurities with charges differing from that of recombinant human granulocyte colony-stimulating factor (rhG-CSF, filgrastim) with superior precision and sensitivity compared to existing methods. A CZE method has been developed, optimized, and validated for a purity assessment of filgrastim in liquid pharmaceutical formulations. Optimal separation of filgrastim from the related impurities with different charges was achieved on a 50 μm id fused-silica capillary of a total length of 80.5 cm. A BGE that contains 100 mM phosphoric acid adjusted to pH 7.0 with triethanolamine was used. The applied voltage was 20 kV while the temperature was maintained at 25°C. UV detection was set to 200 nm. Method was validated in terms of selectivity/specificity, linearity, precision, LOD, LOQ, stability, and robustness. Linearity was observed in the concentration range of 6-600 μg/mL and the LOQ was determined to be 0.3% relative to the concentration of filgrastim of 0.6 mg/mL. Other validation parameters were also found to be acceptable; thus the method was successfully applied for a quantitative purity assessment of filgrastim in a finished drug product.
Ključne riječi (engleski)
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran - međunarodna recenzija
Verzija publikacijeObjavljena verzija rada (izdavačev PDF)
Naslov časopisaELECTROPHORESIS
Brojčani podacivol. 35, br. 18, str. 2608-2614
p-ISSN0173-0835
e-ISSN1522-2683
DOIhttps://doi.org/10.1002/elps.201300552
URN:NBNurn:nbn:hr:239:631162
Datum objave publikacije2014
URL dokumentahttps://onlinelibrary.wiley.com/doi/full/10.1002/elps.201300552
Vrsta resursaTekst
Prava pristupaOtvoreni pristup
Uvjeti korištenjaIkona licence Zaštićeno autorskim pravom.
Datum i vrijeme pohrane2020-05-11 08:33:11