1. Cromatografía de adsorción para purificar el disacárido espaciador del ingrediente farmacéutico activo de la vacuna QuimiHib®.
- Author
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Díaz, Belinda, Heynngnezz, Lázaro, Beldarraín, Alejandro, Iser, Yadira, Fernández, Abel, Díaz, Jesús, Duarte, Rainier, García, Yuliasne, Martorell, Yaima, and Sosa, Iván Manuel
- Subjects
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DISACCHARIDES , *ADSORPTION (Biology) , *CHROMATOGRAPHIC analysis , *PHARMACEUTICAL industry , *HAEMOPHILUS influenzae - Abstract
In this paper we study the conditions of adsorption chromatography on Silica gel 60 for purification of Spacer disaccharide a component of Active Pharmaceutical Ingredient (API) of QuimiHib® vaccine. For that, we made a scale down on an analytical scale that represented at 1.8% of industrial process, indicating reproducibility between two procedures in terms of packing efficiency, purity and recovery. Dynamic binding capacity of the resin Silicagel 60 by the DSE was roughly 125±0.2 mg /mL, 3.4 times the base process. The elution profile obtained, showed the possibility of collecting a unique fraction at range 195±2 and 260±2 minutes, if it is maintained a proper packing of the chromatography resin determined by asymmetry factor from 0.8 to 1.2, which ensures a recovery of 58.9±4.5% and high purity analyzed by Thin Layer Chromatography. Adjusting the adsorption conditions increases the productivity of chromatographic operation up to 3.5 fold, indicating that it is feasible in economic terms. [ABSTRACT FROM AUTHOR]
- Published
- 2013