Flórez López, EdwinGutiérrez, HiulderRojas Daza, Andrés FelipeCastro Bonilla, Duván Andrés2024-09-242024-09-242024Rojas Daza, A. F., & Castro Bonilla, D. A. (2024). 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.https://repositorio.usc.edu.co/handle/20.500.12421/5637La industria farmacéutica hace parte de los sistemas de apoyo sanitario más importante a nivel mundial, lo forman organizaciones públicas y privadas que se dedican al descubrimiento, desarrollo, fabricación y comercialización de medicamentos para brindar una mejor calidad de vida en salud humana y animal. Para ello, requieren diversos productos químicos o naturales de los cuales, se deben garantizar una alta calidad para la fabricación de medicamentos como los principios activos y excipientes (Tait, 2019)In 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 resultsapplication/pdf21 páginasesAlcohol EstearilicoCromatografía de Capa FinaEstearil Fumarato SódicoMonoestearil MaleatoResoluciónseparaciónThesisAcceso privadoReconocimiento 4.0 Internacional (CC BY 4.0)