Norfloxacin Impurity 12 (CAS 1911573-08-4) es una impureza relacionada con la síntesis y degradación del norfloxacino cuya detección precisa es crítica para el control de calidad farmacéutico. Su carácter estructural y perfil analítico se determinan mediante técnicas como HPLC con detección UV | LC-MS para confirmación de masa y RMN para elucidación estructural. Esta impureza puede originarse por reacciones secundarias en etapas de síntesis | impurezas de partida o degradación durante almacenamiento | influyendo en la estabilidad del lote y en los límites de aceptación regulatorios. Se requieren métodos validados | estudios de degradación forzada y controles de proceso para minimizar su presencia y asegurar cumplimiento normativo.
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