Naslov
Development of the Robust Capillary Electrophoretic Approach to Determination of Impurities in Biopharmaceuticals

Autori
Debeljak, Željko ; Srečnik, Goran ; Medić-Šarić, Marica

Vrsta, podvrsta i kategorija rada
Radovi u zbornicima skupova, cjeloviti rad (in extenso), znanstveni

Izvornik
4th Slovenian Symposium on Separation Techniques: Book of Abstracts / Prošek, Mirko ; Vovk, Irena ; Medja, Armin - Ljubljana : National Institue of Chemistry, 2002, 25-33

ISBN
961-6104-05-5

Skup
4th Slovenian Symposium on Separation Techniques

Mjesto i datum
Novo Mesto, Slovenija, 03.10.2002. - 04.10.2002

Vrsta sudjelovanja
Pozvano predavanje

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
capillary electrophoresis; impurities; biopharmaceuticals

Sažetak
An overview of the capillary electrophoretic techniques used by bioanalytical laboratories for the determination of recombinant DNA technology (rDNA) products' impurities and related compounds approved by regulatory authorities will be given. Decision tree for the selection of the pharmaceutically acceptable CE conditions is described. According to the selection made this way a subset of different ion-pairing additives and capillary zone electrophoretic conditions is put under thorough experimental examination. Based on a full factorial experimental design on the protein standard test mixtures the set of the best conditions is taken for the "real world" analyses of rDNA pharmaceutical dosage forms.

Izvorni jezik
Engleski

Znanstvena područja
Kemija, Farmacija, Biotehnologija

POVEZANOST RADA