Información adicional sobre el Pitofenone Impurity 2
Fármaco de origen
Pitofenone
Nombre IUPAC
N-Ethyl-2, 2-diphenyl-N-(piperidin-1-yl)acetamide
Sinónimos
N/A
Descripción
Impureza Pitofenona 2 es un subproducto observado en el proceso de síntesis y en estudios de estabilidad de pitofenona | identificado por perfil cromatográfico y espectrometría de masas. Se caracteriza por un pico específico en HPLC con tiempo de retención reproducible y masas moleculares compatibles con modificaciones estructurales esperadas. Su control requiere métodos analíticos validados como HPLC-UV | LC-MS y RMN para determinar identidad | límite de cuantificación y niveles aceptables en especificaciones. La evaluación de su formación mediante estudios de degradación forzada permite optimizar condiciones de síntesis y almacenamiento | minimizando riesgos de calidad y garantizando cumplimiento regulatorio.
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