Atorvastatin Acyl-β-D-glucuronide (CAS 463962-58-5) es una impureza relevante en el perfil de calidad de la atorvastatina y sus materias primas. Su detección y cuantificación mediante HPLC con detección por MS o LC-MS/MS es crítica para la caracterización del API y la evaluación de vías de degradación y conjugación durante síntesis y almacenamiento. La presencia de este glucurónido puede indicar reacciones de acilación o biotransformación inadvertida y requiere estándares de referencia | límites de aceptación definidos y estudios de calificación para cumplir requisitos regulatorios. Su monitorización contribuye a garantizar pureza | estabilidad y trazabilidad en el control de calidad farmacéutico.
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