La impureza N-óxido de abacavir (CAS 1443421-70-2) es una impureza de proceso relacionada con el metabolito oxidativo del inhibidor nucleósido carbocíclico de la transcriptasa inversa abacavir, generada por inserción de oxígeno en el nitrógeno del anillo para formar una función N-óxido. Con fórmula molecular C14H18N6O2 y peso molecular de 302.34 g/mol, corresponde a una especie heteroaromática polar con comportamiento cromatográfico diferenciado del fármaco original. Su determinación suele requerir LC-MS/MS o LC-HRMS, ya que la detección UV a menudo no permite una asignación inequívoca. En el perfil de impurezas se evalúa como degradante oxidativo o variante asociada a síntesis bajo marcos de control coherentes con ICH.
Referencias
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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