Almotriptan EP Impurity C, identificado como la sal de ácido 2-hidroxisuccinico, constituye una impureza crítica en el perfil de calidad del almotriptán que requiere vigilancia analítica rigurosa. Su formación suele asociarse a rutas de síntesis y condiciones de degradación hidrolítica, aportando masa y polaridad distintas que afectan purificación y estabilidad. Se recomienda monitorizarla mediante ensayos validados de HPLC y LC-MS para cuantificación y estudios de degradación forzada. Estrategias de control incluyen optimización de etapas sintéticas, condiciones de limpieza y límites especificados en monografías. La evaluación toxicológica y la documentación de conformidad regulatoria son esenciales para garantizar aceptabilidad en el lote final.
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