3 Hydroxy Abacavir é uma impureza oxidativa observada em lotes de abacavir | originada por hidroxilação no carbono 3 durante síntese ou degradação. Caracteriza-se por massa molecular incrementada e espectro de fragmentação distinto em LC-MS | e por ligeira alteração no tempo de retenção em HPLC em fase reversa. Sua identificação e quantificação requerem métodos validados | tipicamente HPLC-UV com padrão de referência ou LC-MS/MS para confirmação estrutural e limites de detecção baixos. O controle inclui otimização de condições de reação | proteção contra oxidação e monitoramento por ensaios de estabilidade | com limites de especificação estabelecidos conforme diretrizes ICH para impurezas de processo.
Referências
Kurmi, Moolchand, et al. “Stability Behaviour of Antiretroviral Drugs and Their Combinations. 5: Characterization of Novel Degradation Products of Abacavir Sulfate by Mass and Nuclear Magnetic Resonance Spectrometry.†Journal of Pharmaceutical and Biomedical Analysis, vol. 134, Feb. 2017, pp. 372–84, https://doi.org/10.1016/j.jpba.2016.10.019. Foster RH, Faulds D. Abacavir. Drugs. 1998 May;55(5):729-36; discussion 737-8. DOI: 10.2165/00003495-199855050-00018. PMID: 9585869.
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