A impureza N-óxido de abacavir (CAS 1443421-70-2) é uma impureza de processo relacionada a metabólito oxidativo do inibidor nucleosídico carbocíclico da transcriptase reversa abacavir, formada pela inserção de oxigênio no nitrogênio do anel, gerando a função N-óxido. Com fórmula molecular C14H18N6O2 e massa molecular de 302.34 g/mol, trata-se de uma espécie heteroaromática polar com comportamento cromatográfico distinto do fármaco de origem. Sua determinação geralmente requer LC-MS/MS ou LC-HRMS, pois a detecção por UV frequentemente não permite atribuição inequívoca. No perfil de impurezas, é tratada como degradante oxidativo ou variante associada à síntese sob estratégias de controle alinhadas aos princípios do ICH.
Referências
Foster RH, Faulds D. Abacavir. Drugs. 1998 May;55(5):729-36; discussion 737-8. DOI: 10.2165/00003495-199855050-00018. PMID: 9585869. ?Vukkum, Pallavi. “Stress Degradation Behavior of Abacavir Sulfate and Development of a Suitable Stability-Indicating UHPLC Method for the Determination of Abacavir, Its Related Substances, and Degradation Products.” Scientia Pharmaceutica, vol. 80, no. 4, 2012, pp. 903–21, https://doi.org/10.3797/scipharm.1206-11.
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