7-Ethyl Theophylline (CAS 23043-88-1), também conhecido como 7-Ethyltheophylline ou 1H-Purine-2,6-dione, 7-ethyl-3,7-dihydro-1,3-dimethyl-, é uma impureza relevante em matérias-primas e processos sintéticos da família da teofilina que exige investigação analítica rigorosa. De perfil polar moderado e estrutura purínica, tende a apresentar tempo de retenção próximo ao composto de interesse em cromatografia reversa, exigindo métodos HPLC-UV ou LC-MS/MS otimizados para separação e quantificação confiáveis. A identificação por espectrometria de massas e confirmação por padrões de referência suportam o estabelecimento de limites de aceitação conforme diretrizes regulatórias. Avaliação de estabilidade e estratégias de amostragem minimizam risco de contaminação cruzada e não conformidade do lote.
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