Ampicillin EP Impurity C (Ampicillin Diketopiperazine | Ampicillin Dione; CAS 49841-96-5) es una impureza ciclada derivada de la degradación intramolecular de la ampicilina. Se detecta por HPLC con confirmación por espectrometría de masas y RMN y tiene importancia en control de calidad por su impacto en la estabilidad y pureza del lote. Su formación se favorece por condiciones de humedad y temperatura y por impurezas intermedias en síntesis. Los límites deben establecerse conforme a monografías y evaluación toxicológica. Su cuantificación precisa y estrategias de mitigación en proceso y en formulación son críticas para garantizar cumplimiento regulatorio y consistencia farmacéutica.
Referencias
Swami, Onkar C. “Ampicillin: Rise Fall & Resurgence.†JOURNAL of CLINICAL and DIAGNOSTIC RESEARCH, 2014, www.ncbi.nlm.nih.gov/pmc/articles/PMC4080027/, 10.7860/jcdr/2014/8777.4356.
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