Dímero de anel aberto da ampicilina (sal 2Na) é uma impureza relevante em lotes de ampicilina que se forma por abertura do anel beta-lactâmico seguida de dimerização em condições de hidrólise | pH elevado ou armazenamento prolongado. Como sal dissódico apresenta maior polaridade e alteração de retenção cromatográfica | exigindo métodos validados de HPLC com detecção UV e confirmação por LC-MS para quantificação robusta. Sua presença pode reduzir a potência do produto final e comprometer especificações de estabilidade | tornando necessária a definição de limites | estratégias de controle de processo | otimização de tempo | temperatura e pH de reação | além de etapas de purificação e monitoramento com base em diretrizes regulatórias aplicáveis.
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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