(3S | 4R)-N-Metil Paroxetina (sal HCl) impureza representa un estereoisómero N-metilado del material de partida que requiere control riguroso durante el desarrollo y la liberación. Esta impureza presenta propiedades fisicoquímicas diferenciadas | mayor polaridad y perfil de solubilidad alterado frente al principio activo. Su presencia impacta en el perfil de pureza | estabilidad y cumplimiento regulatorio | por lo que se recomienda monitoreo por HPLC-UV | LC-MS y RMN y evaluación mediante HPLC quiral para separación de estereoisómeros. Las estrategias de control incluyen límites especificados en la especificación | estudios de degradación forzada y procedimientos analíticos validados para garantizar calidad y seguridad del lote.
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