Impureza (E)-ethyl 2-((5-(ethoxycarbonyl)-2-methylphenyl)diazenyl)-5-guanidino-4-methylbenzoate é um subproduto azoico que pode surgir durante etapas de diazotação | acoplamento ou guanidinação | comprometendo a pureza do princípio ativo e gerando perfil cromatográfico complexo. Apresenta cromoforia fortemente absorvente em UV e maior lipofilicidade relativa | resultando em tempo de retenção elevado em HPLC reverso e comportamento variável em fase normal. A caracterização exige LC-MS para determinação do m/z e padrões de fragmentação | RMN para confirmação estrutural e ensaios de estabilidade para avaliar sensibilidade à redução | hidrólise de ésteres e fotodegradação. Recomenda-se validação analítica | limites de aceitação e estudos de spiking para controle regulatório.
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