Salcaprozate Impurity 1 (CAS: 1027911-46-1) | identificada también como 8-(2-hydroxy-benzolylamino)octanoic acid ethylester | es una impureza estructural que presenta grupos fenólico | amino y éster | lo que determina su polaridad intermedia y susceptibilidad a hidrólisis y oxidación. Desde el punto de vista analítico su perfil se define por espectros NMR con señales aromáticas y múltiples metileno en la cadena octanoica | patrón de fragmentación característico en LC-MS y absorción UV adecuada para HPLC-UV a 254 nm. Su presencia exige control mediante métodos validados de cromatografía y purificación | límites de aceptación y estudios de estabilidad para garantizar la calidad del material.
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