Atorvastatin (3R | 5S)-Isomer (sal de calcio) | CAS 1312366-79-2 | es una impureza estereoquímica relevante en la síntesis de atorvastatina que puede originarse por epimerización o resolución incompleta. Su presencia afecta la pureza enantiomérica y puede alterar la potencia y perfil farmacocinético del lote. Se recomienda su identificación y cuantificación mediante HPLC quiral validado | espectrometría de masas y RMN para confirmar configuración 3R | 5S y composición aniónica calciómica. Estrategias de control de calidad incluyen límites especificados en monografías | condiciones de síntesis optimizadas y pruebas de estabilidad forzadas. Documentar y controlar esta impureza es crítico para cumplimiento regulatorio y seguridad del producto.
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