(E)-2-Nonenedioic Acid (CAS 72461-80-4) aparece como impureza insaturada en síntesis y degradación de ácidos dicarboxílicos; su doble enlace en configuración E modifica la acidez y la reactividad | pudiendo afectar estabilidad y perfil analítico del lote. Se detecta y cuantifica mediante HPLC-UV con columnas de fase reversa | GC-MS tras derivatización y espectroscopía de RMN para confirmación estructural. Se recomienda establecer límites de aceptación específicos | controles de proceso para minimizar isomerización y oxidación | y pruebas de estabilidad en condiciones aceleradas. La identificación temprana reduce riesgos en control de calidad y asegura cumplimiento regulatorio del perfil de impurezas.
Referencias
Del Rosso, James Q. “Azelaic Acid Topical Formulations: Differentiation of 15% Gel and 15% Foam.†The Journal of Clinical and Aesthetic Dermatology, vol. 10, no. 3, 1 Mar. 2017, pp. 37–40, www.ncbi.nlm.nih.gov/pmc/articles/PMC5367880/.
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