Impureza 3-(Acetyloxy)-2 | 3-dihidro-2-(4-metoxifenil)-5-metil-1 | 5-benzotiazepin-4(5H)-ona (CAS 2067323-40-2) é um subproduto acetilado frequentemente detectado durante a síntese de benzotiazepinas | cuja identificação e quantificação são essenciais para controle de qualidade. A caracterização analítica combina cromatografia HPLC com determinação de tempo de retenção | espectrometria de massas para massa molecular e fragmentação | e RMN para confirmação estrutural. A presença dessa impureza pode comprometer a pureza do princípio ativo e a estabilidade do lote | exigindo definição de limites aceitáveis | desenvolvimento de métodos com LOD/LOQ apropriados | e estratégias de mitigação no processo | incluindo otimização de reação e purificação | além de padronização de referência para testes.
Referências
“Diltiazem: MedlinePlus Drug Information.” Medlineplus.gov, 2017, medlineplus.gov/druginfo/meds/a684027.html.
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