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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Scientific paper - Original scientific paper
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. & 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, no. 18, 2014, pp. 2608-2614. https://doi.org/10.1002/elps.201300552

Benković, Goran, Ana Škrlin, Tomislav Madić, Željko Debeljak and Marica Medić Šarić. "Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis." ELECTROPHORESIS 35, no. 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), pp. 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 [cited 2024 November 18];35(18):2608-2614. doi: 10.1002/elps.201300552

G. Benković, A. Škrlin, T. Madić, Ž. Debeljak and M. Medić Šarić, "Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis", ELECTROPHORESIS, vol. 35, no. 18, pp. 2608-2614, 2014. [Online]. Available at: https://urn.nsk.hr/urn:nbn:hr:239:631162. [Accessed: 18 November 2024]

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Metadata
Title (english)Purity Assessment of Recombinant Human Granulocyte Colony-stimulating Factor in Finished drug Product by Capillary Zone Electrophoresis
AuthorGoran Benković
AuthorAna Škrlin
AuthorTomislav Madić
AuthorŽeljko Debeljak
MBZ: 296571
AuthorMarica Medić-Šarić
MBZ: 74265
Author's institutionUniversity of Zagreb
Faculty of Pharmacy and Biochemistry
Scientific / art field,
discipline and subdiscipline		NATURAL SCIENCES
Biology
Biochemistry and Molecular Biology
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Basic Medical Sciences
Pharmacology
Abstract (english)
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.
Keywords (english)
Languageenglish
Publication typeScientific paper - Original scientific paper
Publication statusPublished
Peer reviewPeer review - international
Publication versionPublished version
Journal titleELECTROPHORESIS
Numberingvol. 35, no. 18, pp. 2608-2614
p-ISSN0173-0835
e-ISSN1522-2683
DOIhttps://doi.org/10.1002/elps.201300552
URN:NBNurn:nbn:hr:239:631162
Publication2014
Document URLhttps://onlinelibrary.wiley.com/doi/full/10.1002/elps.201300552
Type of resourceText
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2020-05-11 08:33:11