4-Methyl-3-(nitroso(4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzoic Acid é uma impureza identificada no desenvolvimento e produção de Nilotinib | também referida como Nilotinib Impurity D ou Benzoic acid 4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]. Caracteriza-se pela presença de grupo nitroso conjugado ao anel benzoico e aos heterociclos piridínico e pirimidínico | influenciando polaridade e comportamento cromatográfico. A detecção e quantificação exigem métodos analíticos sensíveis como HPLC com detecção UV e LC-MS/MS para confirmação de massa e fragmentação. A compreensão da via de formação | estabilidade térmica e reatividade é essencial para estabelecer limites de especificação e estratégias de controle que garantam conformidade regulatória e qualidade do produto.
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