Amoxicillin alpha-penicilloic acid (CAS 87860-49-9) es una impureza de degradación derivada de la apertura del anillo beta-lactámico de la amoxicilina; se identifica y cuantifica rutinariamente durante el control de calidad por HPLC unido a detección UV | confirmada por espectrometría de masas y NMR. Su presencia indica degradación y puede reducir la potencia del principio activo | alterar perfiles de estabilidad y causar interferencias analíticas. La monitorización según ICH Q3A/B y límites especificados en especificaciones del lote es esencial para garantizar seguridad y eficacia. Los métodos validados de cuantificación y criterios de aceptación permiten evaluar riesgos y optimizar condiciones de formulación y almacenamiento.
Referencias
Akhavan, Bobak J., et al. Amoxicillin.†Nih.gov, StatPearls Publishing, 17 Aug. 2021, www.ncbi.nlm.nih.gov/books/NBK482250/.
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