Amoxicillin Related Compound 1 (Free Base) é uma impureza relacionada da amoxicilina | identificada sob CAS 26531-82-8 | frequentemente monitorada em controle de qualidade farmacêutico. Esta impureza é caracterizada por propriedades físico-químicas específicas e detectável por cromatografia líquida de alta eficiência HPLC com detectores UV e por espectrometria de massas para confirmação de massa molecular. A quantificação e o estabelecimento de limites aceitáveis em lotes e estudos de estabilidade são críticos para conformidade com monografias e boas práticas de fabricação. Pode formar-se por degradação térmica ou hidrolítica da substância ativa | exigindo protocolos robustos de amostragem e validação analítica.
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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