A impureza associada a Phenoxybenzamine hydrochloride CRS (Y0002282 | CAS 63-92-3) consiste em subprodutos de alquilação e clivagem que podem incluir sais de benzoila e derivados N-desmetilados | também referidos como N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl)benzylamine Hydrochloride e Dibenzyline Hydrochloride. Esta impureza apresenta solubilidade em meios aquosos ácidos | estabilidade limitada a temperaturas elevadas e perfil cromatográfico próximo ao princípio ativo. Para controlo de qualidade são recomendados métodos como HPLC com detecção UV e MS para quantificação e identificação | ensaios de pureza por titulação e cromatografia de camada delgada para triagem. Limites de aceitação | validação de método e armazenamento a baixa temperatura minimizam seu impacto.
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