Impureza 3 de leflunomida (CAS 62004-05-1) | también conocida como 3-Trifluoro Isomer | es una impureza estructural detectada durante la síntesis del API. Su caracterización físico-química y masa exacta se confirma por RMN | LC-MS y HPLC con detección UV | permitiendo cuantificación de trazas y vigilancia analítica. La evaluación de su estabilidad | rutas de formación y límites aceptables según guías regulatorias resulta esencial para el control de calidad. Se recomiendan métodos analíticos validados y medidas de optimización del proceso para minimizar su presencia y garantizar cumplimiento de especificaciones.
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