La impureza Citalopram Didesmethyl (base libre), conocida como N,N-DiDesmethyl Citalopram (CAS 62498-69-5), es un derivado estructural frecuente derivado de reacciones de desmetilación durante la síntesis o degradación del principio activo. Relevante en control de calidad, requiere identificación y cuantificación mediante técnicas cromatográficas acopladas a espectrometría de masas y caracterización por RMN para confirmar su estructura. Su presencia puede influir en la pureza y estabilidad del lote, y debe gestionarse conforme a umbrales regulatorios ICH para impurezas orgánicas. Las estrategias de mitigación incluyen optimización del proceso, purificación selectiva y estudios de degradación forzados.
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