Impureza N’-(L-Seryl)-N-(2 | 3 | 4-trihydroxybenzyl)nitrous Hydrazide es un subproducto polar caracterizado por múltiples grupos hidroxilo y una unidad hidrazida que le confieren elevada polaridad y capacidad de formar enlaces por puente de hidrógeno. Esta impureza puede interferir en el perfil de pureza del principio activo | alterar la estabilidad y complicar la cuantificación analítica si no se controla. Es detectable mediante HPLC-UV/LC-MS y confirmable por RMN y espectroscopía IR | por lo que su monitoreo mediante métodos validados y límites especificados es crítico para el control de calidad y el cumplimiento regulatorio del producto farmacéutico.
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