Impureza Amlodipine Besilate CRS (Y0000049 | CAS 111470-99-6) corresponde ao sal benzenossulfonato do composto 3 | 5-Pyridinedicarboxylic acid | 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1 | 4-dihydro-6-methyl- | 3-ethyl 5-methyl ester | benzenesulfonate (1:1). Esta impureza apresenta perfil cromatográfico e espectral bem definido | incluindo sinais consistentes em NMR e espectrometria de massa | e é normalmente detectada por técnicas HPLC e LC-MS em controlos de qualidade. Quimicamente é um sal que pode originar-se por rotas sintéticas ou degradação do princípio ativo. Suas propriedades físico-químicas influenciam solubilidade e estabilidade | exigindo condições analíticas e de armazenamento controladas para avaliação precisa.
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