(2S)-(t-Butylamino)-3′-chloropropiophenone L-tartaric acid salt
Sinónimos
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Descripción
Bupropion (S)-isómero (CAS 324548-43-8) es una impureza enantiomérica crítica en el control de calidad de ingredientes farmacéuticos activos. Como enantiómero ópticamente activo | puede modificar el perfil farmacocinético y la potencia relativa del producto final | por lo que su identificación y cuantificación son esenciales. Se detecta y cuantifica mediante técnicas quiralmente selectivas como HPLC quiral | polarimetría | dicroísmo circular y RMN con reactivos quirales. El control incluye establecimiento de límites en especificaciones según guías ICH y validación de métodos para asegurar el exceso enantiomérico y la estabilidad durante síntesis y almacenamiento. Información técnica precisa facilita el cumplimiento regulatorio y la gestión de riesgos.
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