Amoxicillin Dimer Tri-Sodium Salt (forma ácido penicilloico) (mezcla de diastereómeros) | CAS 210289-72-8 | es una impureza de degradación clave en materias primas y productos que contienen amoxicilina. Se genera por apertura del anillo betalactámico seguida de dimerización del ácido penicilloico | dando lugar a isómeros no enantioméricos con propiedades fisicoquímicas y comportamiento cromatográfico distintos. Su presencia afecta la pureza | estabilidad y perfil de seguridad del producto final | por lo que su cuantificación requiere métodos analíticos validados como HPLC con detección UV o LC-MS y estudios forzados de estabilidad. El control de lote y los criterios de aceptación son críticos para el cumplimiento regulatorio.
Referencias
Akhavan, Bobak J, and Praveen Vijhani. Amoxicillin.†Nih.gov, StatPearls Publishing, 7 Mar. 2019, www.ncbi.nlm.nih.gov/books/NBK482250/.
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