La impureza Diclofenac Dimer (CAS 1609187-30-5) es un producto de dimerización que puede formarse por acoplamiento oxidativo del principio activo durante fabricación o almacenamiento. Presenta propiedades químicas y de estabilidad distintas al monómero | pudiendo afectar la pureza | el perfil de descomposición y la cuantificación analítica. Su detección y cuantificación requieren técnicas sensibles como HPLC con detección UV o LC-MS para establecer límites de aceptación y estrategias de control de calidad. La gestión de riesgo incluye optimización de procesos sintéticos | condiciones de formulación y estudios de estabilidad forzados para minimizar su presencia y cumplir requisitos regulatorios de impurezas relacionadas.
Referencias
Azougagh, M., et al. “A Novel Stability-Indicating UPLC Method Development and Validation for the Determination of Seven Impurities in Various Diclofenac Pharmaceutical Dosage Forms.†Annales Pharmaceutiques Françaises, vol. 74, no. 5, Sept. 2016, pp. 358–69, https://doi.org/10.1016/j.pharma.2016.07.001.?Sallmann, Alfred R. “The History of Diclofenac.†The American Journal of Medicine, vol. 80, no. 4, Apr. 1986, pp. 29–33, https://doi.org/10.1016/0002-9343(86)90076-8.
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