Abacavir EP Impurity E (CAS 208762-35-0) | también denominada Dihydro Abacavir o [(1R | 3S)-3-[2-amino-6-(cyclopropylamino)purin-9-yl]cyclopentyl]methanol | es una impureza clave en el perfil de calidad de abacavir que requiere control analítico riguroso. Se caracteriza por cambios en el núcleo purínico y la reducción parcial del anillo | lo que puede originarse durante síntesis o condiciones de hidrogenación. Su identificación y cuantificación se realiza por HPLC con detección UV y confirmación por LC-MS y RMN. La evaluación de límites | estabilidad y posibles efectos sobre la potencia del lote es esencial para cumplimiento de monografías y especificaciones regulatorias.
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.
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