Información adicional sobre el Trans - Aminocarbinol
Fármaco de origen
Abacavir
Nombre IUPAC
((1R, 4R)-4-aminocyclopent-2-en-1-yl)methanol
Sinónimos
N/A
Descripción
La impureza trans-aminocarbinol presenta un desafío en el perfil de impurezas por su polaridad y tendencia a formarse durante etapas reductivas y de protección de grupos funcionales | afectando rendimiento y estabilidad del intermedio. Su identificación requiere técnicas analíticas robustas como HPLC | LC-MS y RMN para distinguir isómeros y cuantificar trazas bajo límites especificados. El control se logra mediante optimización de condiciones de reacción | limpieza por cromatografía y métodos de escavengado de aminas | además de estudios de estabilidad forzada para definir especificaciones y criterios de aceptación. La documentación analítica y procedimientos de muestreo son críticos para asegurar cumplimiento regulatorio.
Referencias
Ann, H., Kim, K.-H., Choi, H.-Y., Chang, H.-H., Han, S. H., Kim, K.-H., … Kim, S.-W. (2017). Safety and Efficacy of Ziagen (Abacavir Sulfate) in HIV-Infected Korean Patients. Infection & Chemotherapy, 49(3), 205. https://doi.org/10.3947/ic.2017.49.3.205
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