Información adicional sobre el N-methyl-N-(4-methylpiperidin-3-yl)nitrous amide
Fármaco de origen
Tofacitinib
Nombre IUPAC
N-methyl-N-(4-methylpiperidin-3-yl)nitrous amide
Sinónimos
N/A
Descripción
N-methyl-N-(4-methylpiperidin-3-yl)nitrous amide es una impureza terciaria polar que puede aparecer en procesos que involucren piperidinas y agentes nitrosantes. Presenta basicidad moderada y afinidad por fases orgánicas y polares | lo que afecta su retención en cromatografía líquida. Su detección y cuantificación se logra mediante métodos validados como HPLC-UV | LC-MS y espectroscopía 1H/13C NMR para confirmación estructural. Desde control de calidad conviene incluirla en el perfil de impurezas con límites especificados y estudios de estabilidad para evaluar su formación durante síntesis y almacenamiento. La identificación temprana y un método analítico robusto facilitan el cumplimiento regulatorio y la seguridad del producto final.
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