Impureza Edoxabán (SRS)-Isómero (CAS 740794-83-6) representa un isómero relacionado crítico identificado durante la síntesis y estabilidad del principio activo. Su perfil analítico incluye retención en HPLC | fragmentación característica en espectrometría de masas y desplazamientos diagnósticos en RMN | lo que permite identificación y cuantificación precisas. La presencia de este isómero puede afectar el perfil de impurezas relacionadas y requiere métodos validados para control de calidad | límites especificados y estudios de degradación forzados. Proporcionamos material de referencia y datos de caracterización para soporte en desarrollo analítico | validación de métodos y cumplimiento regulatorio.
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