La impureza p-clorofenilo de Citalopram es un subproducto de síntesis y posible degradado que requiere caracterización rigurosa dentro del perfil de impurezas | dado su impacto en la calidad del principio activo; su identificación se realiza mediante HPLC con detector UV para perfil cromatográfico | confirmación de masa por espectrometría de masas y elucidación estructural por RMN | mientras que la cuantificación se valida por métodos analíticos robustos siguiendo ICH Q3A/Q3B; el control se consigue mediante optimización de condiciones de reacción | purificación y estudios de estabilidad en condiciones aceleradas y reales | estableciendo límites aceptables y criterios de liberación para garantizar cumplimiento regulatorio.
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