Impureza Simvastatin acyl-b-D-glucuronide (CAS 463962-56-3) es un metabolito relacionado que puede aparecer como impureza en materias primas y lotes de simvastatina. Su presencia refleja conjugación acílica con ácido glucurónico mediante reacciones en proceso o biotransformación residual y puede alterar el perfil de impurezas, estabilidad y biodisponibilidad del producto. Se recomienda identificación y cuantificación mediante HPLC acoplado a espectrometría de masas (LC-MS/MS) y confirmación estructural por RMN. El control analítico debe incluir métodos validados, límites de aceptación basados en ICH Q3A/Q3B y evaluación toxicológica para garantizar cumplimiento regulatorio y calidad del medicamento.
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