Información adicional sobre el Prucalopride Impurity 44
Fármaco de origen
Prucalopride
Nombre IUPAC
5-(2-bromoethoxy)-2-chloroaniline
Sinónimos
N/A
Descripción
Prucalopride impureza 44 | impureza 44 de prucaloprida | es un subproducto observado en el proceso de síntesis y en estudios de estabilidad que requiere control riguroso para garantizar el perfil de impurezas del producto final. Técnicamente | se caracteriza mediante HPLC-UV para cuantificación y LC-MS junto con RMN para la confirmación estructural. Su aparición se asocia a reacciones secundarias como oxidación parcial o reordenamientos químicos durante etapas de protección y desprotección. Se recomienda optimizar condiciones de reacción | aplicar purificación preparativa y establecer límites y procedimientos de muestreo según ICH Q3A/Q3B. El conocimiento de su comportamiento en estrés y su identificación estructural son críticos para la evaluación de seguridad y calidad.
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