engleski

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

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.

capillary electrophoresis; impurities; biopharmaceuticals

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