Amoxicillin Related Compound 1 (Free Base) (CAS 26531-82-8) es una impureza relacionada con amoxicilina en su forma de base libre | relevante para control de calidad y perfiles de degradación. Se origina durante síntesis y almacenamiento y presenta propiedades físicoquímicas que afectan solubilidad y comportamiento cromatográfico. La identificación y cuantificación se realiza habitualmente mediante HPLC y LC-MS con métodos validados y límites de especificación definidos para minimizar riesgos de seguridad y eficacia. Su monitorización es crítica en estudios de estabilidad | desarrollo de procesos y cumplimiento regulatorio | permitiendo optimizar condiciones de purificación y establecer estrategias de mitigación.
Referencias
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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