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ISSN 1025-0298 (Electronic)
ISSN 1025-028X (Print)

2013, Number 1

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VacciMonitor 2013; 22 (1)

Adsorption chromatography to purify Spacer disaccharide of Active Pharmaceutical Ingredient of QuimiHib® vaccine

Díaz B, Heynngnezz L, Beldarraín A, Iser Y, Fernández A, Díaz J, Duarte R, García Y, Martorell Y, Sosa IM

Language: Spanish
References: 11
Page: 29-34
PDF size: 172. Kb.


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.


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