La impureza 3-hidroxi abacavir es un producto relacionado detectable durante la síntesis y el almacenamiento del principio activo | generado por reacciones de oxidación o modificaciones en el grupo hidroxilo. Su identificación y cuantificación mediante HPLC-UV confirmada por LC-MS y caracterización por RMN son esenciales para el perfil de impurezas y para cumplir ICH Q3A/Q3B. El control analítico incluye métodos validados | límites de aceptación | estudios de estabilidad y estrategias de purificación para minimizar su presencia. Mantener especificaciones y disponer de un estándar de referencia permite evaluar el impacto en seguridad y eficacia y asegurar continuidad en la calidad del lote.
Referencias
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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