Impureza 3-Fluro Diketoatorvastatin Derivative representa una desviación estructural en la síntesis de atorvastatina que incorpora un anillo fluorado y un sistema diketo alterado. Técnicamente | esta impureza puede originarse por reacciones secundarias durante etapas de quimificación y oxidación | formación de isómeros regioquímicos o desprotección incompleta. Su presencia afecta el perfil de pureza y requiere control mediante métodos analíticos validados como HPLC con detección UV | LC-MS y RMN para identificación y cuantificación. El establecimiento de límites de especificación | optimización de las condiciones de reacción y pasos de purificación dirigidos son esenciales para mitigar su formación y cumplir los requisitos regulatorios de calidad.
Referencias
“Atorvastatin (Oral Route) Description and Brand Names – Mayo Clinic.” Mayoclinic.org, 2023, www.mayoclinic.org/drugs-supplements/atorvastatin-oral-route/description/drg-20067003#:~:text=Atorvastatinisusedtogetherwith,fatscloggingthebloodvessels. Accessed 15 Apr. 2023.
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