Impureza D del ácido azelaico (Undecanedioic Acid | CAS 1852-04-6) es un subproducto lineal identificado durante síntesis y purificación que requiere control analítico por su potencial impacto en estabilidad y cumplimiento de especificaciones. Presenta masa molecular y patrones de fragmentación característicos detectables por LC-MS y GC-MS | y señales definidas en RMN 1H y 13C que facilitan su confirmación estructural. Se recomienda monitoreo por HPLC con detección UV o MS para cuantificación y perfiles de impurezas | y evaluación de su solubilidad y punto de fusión para estudios de formulación y degradación. Datos robustos permiten establecer límites y criterios de aceptación.
Referencias
Breathnach, A.S. “Pharmacological Properties of Azelaic Acid.†Clinical Drug Investigation, vol. 10, no. Supplement 2, 1995, pp. 27–33, 10.2165/00044011-199500102-00005. Accessed 4 Feb. 2020.
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