Impureza (R)-2-(tert-butylamino)-3-(4-iodophenyl)propan-1-ol é um subproduto quiral com centro estereogênico R e substituinte iodo no anel fenílico que requer controle atento em processos sintéticos. Seu perfil analítico inclui separação por HPLC quiral e achados por LC-MS e HRMS | caracterização estrutural por 1H/13C NMR e determinação de pureza por cromatografia e titulação. Potenciais vias de formação são racemização parcial | N-dealquilação e halogenação dupla | afetando especificações de impurezas relacionadas e estabilidade. Recomenda-se armazenamento sob temperatura controlada e implementação de limites de especificação | ensaios de perfil e estratégias de purificação para minimizar impacto em lotes.
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