Informações adicionais sobre o Pitofenone Impurity 2
Fármaco de origem
Pitofenone
Nome IUPAC
N-Ethyl-2, 2-diphenyl-N-(piperidin-1-yl)acetamide
Sinônimos
N/A
Descrição
Impureza Pitofenone 2 é um subproduto observado durante a síntese ou degradação do Pitofenone | cuja identificação e quantificação são críticas para o controle de qualidade. Caracteriza-se por distinto tempo de retenção em cromatografia líquida e por diferenças de massa detectáveis por LC-MS | permitindo perfilagem por HPLC-UV e confirmação estrutural por RMN. Seu monitoramento apoia estudos de estabilidade e avaliação de vias de formação | incluindo reações secundárias e produtos de hidrólise. Especificações seguirão diretrizes regulatórias para limites de impurezas | exigindo padrão de referência apropriado e métodos validados que garantam sensibilidade | seletividade e reprodutibilidade em ambientes GMP.
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