Dimetil azelato (CAS 1732-10-1) es una impureza lipofílica que puede formarse durante reacciones de esterificación del ácido azelaico o por transesterificación incompleta; su presencia afecta el perfil de impurezas y la estabilidad de lotes. Se detecta y cuantifica rutinariamente mediante GC-MS y HPLC con detección por UV o MS, y su confirmación estructural se realiza con RMN de protones y espectroscopía IR. Desde el punto de vista de control de calidad, Dimetil azelato puede modificar propiedades fisicoquímicas y organolépticas y por ello requiere límites especificados, criterios de purificación validados y documentación analítica completa para garantizar conformidad regulatoria.
Referencias
Nazzaro-Porro, Marcella. “Azelaic Acid.†Journal of the American Academy of Dermatology, vol. 17, no. 6, 1 Dec. 1987, pp. 1033–1041, www.sciencedirect.com/science/article/abs/pii/S0190962287702941, 10.1016/S0190-9622(87)70294-1. Accessed 28 Jan. 2022.
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