Impureza (4′-Methyl-(1 | 1′-biphenyl)-2-yl)(p-tolyl)methanone é um subproduto observado em rotas de síntese que empregam acoplamentos arila arila e reações de acilação; pode originar-se de acoplamento incompleto | reações laterais ou decomposição térmica e deve ser monitorada por seu impacto na pureza do produto final. A identificação e quantificação são realizadas por HPLC com padrão de referência | LC-MS para confirmação da massa molecular e RMN para elucidação estrutural. Estratégias de controle incluem otimização de condições reacionais | purificação por cromatografia preparativa e recristalização. Limites e documentação analítica conforme diretrizes ICH mitigam risco regulatório e asseguram consistência de lote.
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