Impureza Rivaroxaban Ethylamino Analog (sal 2HCl) é uma impureza relacionada estruturalmente ao API que ocorre como sal di-hidroclorídrico do análogo etilamino. Apresenta aumento de polaridade relativo ao composto de referência, comportamento cromatográfico distinto em fase reversa e resposta sensível por LC-MS/MS e HPLC-UV. É tipicamente gerada durante etapas sintéticas ou em condições de degradação aminada e requer isolamento, caracterização por RMN e espectrometria de massas e avaliação de estabilidade. Sua presença influencia o perfil de pureza e a necessidade de controles analíticos e especificações de lote, incluindo estudos toxicológicos, limites aceitáveis e procedimentos analíticos de controle.
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