Hyoscine Butylbromide EP Impurity G, também denominada Hyoscine Apo-N-Butyl Impurity, é um derivado de alcaloide tropânico estruturalmente definido, com fórmula molecular C21H28NO3 e massa molecular de 342,45 g/mol. O perfil é compatível com um produto de degradação desquaternizado ou rearranjado, originado por processos de clivagem ou eliminação que afetam o esqueleto de escopolamina butilada durante a síntese ou sob პირობas de estresse. Como impureza não nitrosamina, sua relevância regulatória reside na caracterização de impurezas e no estabelecimento de especificações conforme requisitos farmacopeicos. A detecção confiável geralmente requer LC-MS/MS para confirmação de identidade e quantificação em traços, com LC-HRMS e separação cromatográfica ortogonal para atribuição de picos e discriminação de impurezas.
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