Leflunomida Related Compound A (HCl Salt) | CAS 90774-69-9 | conocido también como Leflunomide EP Impurity A (HCl Salt) o p-trifluoromethylaniline hydrochloride | es una impureza clave derivada de la síntesis de leflunomida. Como sal clorhídrica | presenta propiedades fisicoquímicas y solubilidad diferenciadas que afectan perfiles de purificación y estabilidad del principio activo. Su identificación y cuantificación mediante HPLC | LC-MS y RMN es esencial para el control de calidad | evaluación de seguridad y cumplimiento farmacopéutico. El control de lote | límites de aceptación | estrategias de eliminación y estudios de degradación son críticos para minimizar su presencia y garantizar conformidad con especificaciones regulatorias.
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