Química Farmacéutica
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Browsing Química Farmacéutica by Subject "Estearil Fumarato Sódico"
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Item Desarrollo de un método alterno comprendido en la farmacopea estadounidense (USP) para la determinación cualitativa de impurezas de monoestearil maleato y alcohol estearílico presentes en el estearil fumarato sódico por cromatografía de capa fina (CCF)(Universidad Santiago de Cali, 2024) Rojas Daza, Andrés Felipe; Castro Bonilla, Duván Andrés; Flórez López, Edwin; Gutiérrez, HiulderIn the pharmaceutical industry, analytical procedures play a crucial role in ensuring the quality, safety and efficacy of materials/products, where reproducible and reliable results are obtained. In the present study, an alternative methodology to that presented by the United States Pharmacopoeia (USP) was developed in the limit test of stearyl alcohol (AE) and monostearyl maleate (MM) of the raw material Sodium stearyl fumarate (SEF), through the thin layer chromatography technique with the in order to improve the separation and resolution (hue/intensity) of the spots of the compounds of interest because in the current methodology these parameters generate a confusing result for the analyst. Different tests were carried out, experimentally studying the stationary phase, modifying the proportions and solvents of the mobile phase and testing different revealing agents. Finally, an alternate procedure was proposed, where the separation of the spots of interest, their intensity and tonality were improved with RF values for sodium stearyl fumarate, stearyl alcohol and monostearyl maleate of 0,35; 0,65; 0,05; compared to what was obtained in the version of the pharmacopoeial methodology of 0,47; 0,48 and 0,40 respectively, which ensures the reliability of the results