El compuesto relacionado con cloroquina E es una impureza de proceso identificada durante la síntesis y el control de calidad de cloroquina. Presenta un perfil cromatográfico y espectrométrico distintivo | detectable por HPLC-UV y LC-MS | y su caracterización se confirma mediante RMN y espectrometría de alta resolución. Su formación se asocia normalmente a rutas de degradación y reacciones secundarias en etapas de acoplamiento y purificación. La presencia de esta impureza reduce la pureza del lote y exige límites de especificación validados | estudios de estabilidad forzados y estrategias de mitigación como optimización de parámetros de reacción y pasos de purificación adicionales para cumplir requisitos regulatorios y asegurar la calidad.
Referencias
RAMAZANI A, and BORNA H. “IN SILICO ANALYSIS and DEVELOPMENT of ANTI- MALARIAL COMPOUNDS against DIHYDROOROTATE DEHYDROGENASE USING CHEMBIOINFORMATIC TOOLS.” International Journal of Pharma and Bio Sciences, vol. 2, no. 2, 2011, p. B-122 – B-131. Goel P, Gerriets V. Chloroquine. In: StatPearls. StatPearls Publishing, Treasure Island (FL); 2020. PMID: 31855356.
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