Ampicillin EP Impurity C (CAS 49841-96-5) | também conhecida como Ampicillin Diketopiperazine ou Ampicillin Dione | é uma impureza de ciclização observada em matérias primas e formulações de ampicilina. Forma-se por ciclização intramolecular da cadeia lateral sob condições de síntese ou armazenamento e apresenta propriedades físico químicas que exigem monitoramento rigoroso. Sua identificação e quantificação são realizadas por HPLC com detecção UV e confirmação por LC MS | com perfil de retenção e espectrometria característicos. A avaliação desta impureza é essencial para controle de qualidade | definição de especificações e conformidade com monografias EP e orientações ICH.
Referências
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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