Impureza Bromfenac B (CAS 91713-90-5) é um composto relacionado sinteticamente ao bromfenac que requer monitoramento rigoroso em controle de qualidade devido ao seu potencial impacto no perfil de pureza do produto final. Caracteriza-se como impureza de processo ou degradação e exige quantificação sensível por HPLC acoplada a detector de arranjo de diodos e confirmação por LC-MS | além de caracterização estrutural por RMN quando necessário. Procedimentos analíticos devem ser validados quanto a limite de detecção | precisão e recuperação | e estratégias de controle incluem otimização de síntese | purificação e estudos de estabilidade para reduzir sua presença abaixo dos limites regulatórios.
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