RESUMEN
A cellulose acetate plate electrophoresis method for analysis of pharmaceutical heparin and its potential glycosaminoglycan impurities, e.g. dermatan sulfate, chondroitin sulfate and oversulfated chondroitin sulfate, is presented. Heparin is chemically degraded by application of nitrous acid and residual glycosaminoglycans are electrophoretically separated thereafter. After staining using Alcian blue 8GS, these glycosaminoglycan impurities can be quantified by means of comparison to a dermatan sulfate standard. Results of a validation study of this analytical method are shown, demonstrating its feasibility for routine use in analytical quality control labs under GMP conditions.
Asunto(s)
Anticoagulantes/análisis , Dermatán Sulfato/análisis , Electroforesis en Acetato de Celulosa/métodos , Glicosaminoglicanos/análisis , Heparina/análisis , Azul Alcián/análisis , Colorantes/análisis , Dermatán Sulfato/metabolismo , Dermatán Sulfato/normas , Contaminación de Medicamentos/prevención & control , Estudios de Factibilidad , Glicosaminoglicanos/metabolismo , Glicosaminoglicanos/normas , Control de Calidad , Estándares de Referencia , Sensibilidad y Especificidad , Coloración y Etiquetado/métodosRESUMEN
NMR cryoporometry is a unique method permitting the investigation of pores in the microporous and mesoporous regimes for samples in aqueous environments. Here, we apply the technique to porous biodegradable polymer microparticles designed as devices for drug delivery in depot formulations. The results indicate that structural features too small to be captured in surface and fracture images obtained by SEM are able to be accessed using the technique, and that the evolution of pore structure can be studied for several days as the particles swell and degrade in the aqueous environment.