Diclofenac EP Impurity D (CAS 127792-23-8) | también conocido como Diclofenac Related Compound D o Diclofenac Bromo Analog | es una impureza halogenada identificada en procesos de síntesis y almacenamiento de diclofenaco. Su estructura bromo adicionada altera propiedades fisicoquímicas y el perfil cromatográfico | por lo que se detecta y cuantifica mediante HPLC con detección UV | LC-MS para confirmación de masa exacta y RMN para elucidación estructural. Su control es esencial en estudios de estabilidad y en la caracterización del perfil de impurezas conforme a monografías farmacéuticas; el establecimiento de límites y métodos de cuantificación apoya la gestión de calidad y el cumplimiento regulatorio.
Referencias
Galmier, Marie-Josèphe, et al. “Identification of Degradation Products of Diclofenac by Electrospray Ion Trap Mass Spectrometry.â€Â Journal of Pharmaceutical and Biomedical Analysis, vol. 38, no. 4, July 2005, pp. 790–96, https://doi.org/10.1016/j.jpba.2005.02.016.
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