Azelaic Acid Inhouse Impurity A (CAS 111-16-0) | también conocido como Pimelic Acid | es una impureza frecuente en procesos de síntesis de ácido azelaico cuya presencia afecta el perfil analítico y la conformidad de lote. Se caracteriza por propiedades físicas y químicas cercanas al producto activo y puede originarse por oxidación incompleta o hidrólisis de intermedios. Su identificación y cuantificación se realizan mediante HPLC con detectores UV | GC cuando procede y confirmación por LC-MS o RMN | con límites de especificación establecidos según riesgo y normativa. El control se basa en limpieza de impurezas | optimización de condiciones de reacción y purificación por recristalización o cromatografía.
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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