Informações adicionais sobre o N | 7-dimethyl-N-((3S | 4S)-4-methyl-1-nitrosopiperidin-3-yl)-6 | 7-dihydro-5H-pyrrolo[2 | 3-d]pyrimidin-4-amine
Fármaco de origem
Tofacitinib
Nome IUPAC
N, 7-dimethyl-N-((3S, 4S)-4-methyl-1-nitrosopiperidin-3-yl)-6, 7-dihydro-5H-pyrrolo[2, 3-d]pyrimidin-4-amine
Sinônimos
N/A
Descrição
A impureza N | 7-dimethyl-N-((3S | 4S)-4-methyl-1-nitrosopiperidin-3-yl)-6 | 7-dihydro-5H-pyrrolo[2 | 3-d]pyrimidin-4-amina apresenta características estruturais críticas para controle de qualidade | incluindo grupo nitroso e dois centros estereogênicos que influenciam perfil cromatográfico e massa precisa. A presença do grupo nitroso recomenda investigação toxicológica e monitoramento analítico rigoroso; métodos validados de HPLC-UV acoplado a LC-MS | espectroscopia de Ressonância Magnética Nuclear e cromatografia quiral são essenciais para identificação e quantificação. Estratégias de controle incluem otimização das etapas de síntese para minimizar formação por nitrosação | purificação direcionada e estabelecimento de limites conforme orientações regulatórias aplicáveis | além de estudos de estabilidade para avaliar degradação.
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