Amoxicillin Alpha Penicilloic Acid (CAS 87860-49-9) é uma impureza relacionada resultante da abertura e hidrólise do anel beta-lactâmico da amoxicilina | com implicações diretas no perfil de estabilidade e pureza do produto. Em estudos de degradação forçada e controle de processo é monitorada por métodos cromatográficos validados | como HPLC e LC-MS | para quantificação e identificação estrutural. O acompanhamento dessa impureza é crítico para validação analítica | estabelecimento de limites de especificação conforme diretrizes ICH e garantia de conformidade em liberação e estudos de estabilidade | reduzindo riscos de interferência analítica e desvios de potência.
Referências
Akhavan, Bobak J., et al. Amoxicillin.†Nih.gov, StatPearls Publishing, 17 Aug. 2021, www.ncbi.nlm.nih.gov/books/NBK482250/.
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