Rivaroxaban Open-Ring Acid (CAS 931204-39-6) é uma impureza relacionada que resulta do escurecimento do anel heterocíclico do composto parental | tipicamente originada por hidrólise ou degradação durante síntese e armazenamento; sua presença compromete o perfil de pureza e estabilidade do API e exige monitorização rigorosa. Esta entidade química é detectável e quantificável por HPLC com detecção UV | LC-MS para confirmação espectrométrica e NMR para elucidação estrutural | devendo ser controlada por limites estabelecidos conforme diretrizes ICH Q3A/Q3B. Estratégias de controle incluem otimização do processo | controle de pH e condições de secagem | além do uso de padrão de referência para análise.
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