Amoxicillin EP Impurity D (CAS 1642629-94-4) | también conocida como Amoxicillin Related Compound D o Amoxicillin Penicilloic Acid | es una impureza degradativa identificada en materia prima y formulaciones de amoxicilina. Su detección y cuantificación son críticas para el control de calidad farmacéutico y el cumplimiento de especificaciones farmacopéyicas. Caracterización analítica mediante HPLC con detección UV | cromatografía líquida acoplada a espectrometría de masas y NMR permite definir su estructura | perfil de fragmentación | pureza y puntos de retención. La caracterización precisa y la cuantificación permiten establecer límites y evaluar su impacto potencial en la seguridad y eficacia del producto.
Referencias
Bucher, Heiner C. “Effect of Amoxicillin-Clavulanate in Clinically Diagnosed Acute Rhinosinusitis.†Archives of Internal Medicine, vol. 163, no. 15, 11 Aug. 2003, p. 1793, 10.1001/archinte.163.15.1793. Accessed 31 Oct. 2019.
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