3-(4-methyl-3-(methyl(7-nitroso-7H-pyrrolo[2 | 3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanenitrile es una impureza estructuralmente compleja que puede surgir por oxidación y nitrosación del principio activo durante la síntesis o en condiciones de almacenamiento; presenta una masa molecular definida y propiedades polares que favorecen su detección por LC-MS y HPLC con detectores UV y MS. Su identificación exige espectrometría de masas de alta resolución y RMN para confirmar la posición del grupo nitroso y las uniones amino. La presencia de esta impureza puede comprometer el perfil de pureza y el cumplimiento de especificaciones | por lo que se recomiendan límites cuantitativos | estrategias de control de proceso | optimización de condiciones de reacción y estudios de degradación forzada para su mitigación.
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