Amoxicillin Impurity 27 (CAS 1978372-79-0) | sinónimo Penicillin Impurity 2 y 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid | 6-[[(2R)-2-amino-2-[(2R | 4S)-4-carboxy-5 | 5-dimetil-2-tiazolidinil]acetil]amino]-3 | 3-dimetil-7-oxo | es una impureza relacionada de la amoxicilina caracterizada por un núcleo tiazolidínico y azabicíclico que impacta el perfil de pureza y la estabilidad del principio activo; su identificación y cuantificación se realizan mediante métodos analíticos sensibles como HPLC y LC-MS | acompañados de RMN para confirmación estructural. La comprensión de sus vías de formación | su comportamiento en estudios de degradación forzada y la definición de límites en especificaciones son esenciales para el control de calidad | la optimización de procesos y el aseguramiento del perfil analítico en fabricación farmacéutica.
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