Diclofenac Impurity 3 (CAS 146607-19-4) es una impureza crítica identificada en procesos de síntesis y formulación de diclofenaco | cuyas propiedades fisicoquímicas requieren control riguroso en gestión de calidad para garantizar cumplimiento de límites y seguridad del producto final. Su identificación y cuantificación se realizan por HPLC con detección UV | con confirmación por espectrometría de masas y caracterización por RMN para determinación estructural. La presencia de esta impureza puede influir en la estabilidad y en la aceptabilidad regulatoria del lote. Proporcionamos material de referencia y datos analíticos para validación de métodos | estudios de degradación y establecimiento de un perfil de impurezas robusto.
Referencias
Goodwin, B. L. Handbook of Biotransformations of Aromatic Compounds. Nov. 2004, https://doi.org/10.1201/9780203641965.?Europe PMC. “Europe PMC.†Europepmc.org, 2016, europepmc.org/article/med/2670397.
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