Impureza de Acetamida de Amoxicilina (CAS 54397-23-8) é um subproduto de síntese e degradação que exige monitorização crítica em controles de qualidade farmacêutica. Caracteriza-se por massa molecular e espectros específicos detectáveis por HPLC | LC-MS e NMR | apresentando polaridade e perfil de retenção distintos da molécula progenitora. Sua formação está associada a condições de reação acetamidação e a processos de armazenamento em presença de agentes acetilantes. Avaliação quantitativa | limites de especificação e estudos de estabilidade são essenciais para garantir conformidade regulatória e segurança. Métodos analíticos validados e procedimentos de purificação robustos permitem minimizar sua presença em lotes de produção.
Referências
Huttner, A., et al. Oral Amoxicillin and Amoxicillin–Clavulanic Acid: Properties, Indications and Usage.†Clinical Microbiology and Infection, vol. 26, no. 7, July 2020, pp. 871–879, 10.1016/j.cmi.2019.11.028.
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