Abacavir EP Impurity D (sal de clorhidrato) | CAS 267668-71-3 | es una impureza relacionada estructuralmente con el núcleo purínico del Abacavir | definida como el enantiómero trans y su sal dihidrocloruro. Presenta propiedades físicoquímicas distintivas | incluyendo mayor solubilidad acuosa frente a la base libre y estabilidad relativa en condiciones ácidas. Su identificación y cuantificación se realiza por HPLC con detección UV | confirmación por espectrometría de masas (MS) y caracterización por RMN 1H/13C. La monitorización rigurosa de esta impureza es crítica para el cumplimiento de especificaciones | evaluación de perfiles de degradación y control de calidad del lote.
Referencias
Foster RH, Faulds D. Abacavir. Drugs. 1998 May;55(5):729-36; discussion 737-8. DOI: 10.2165/00003495-199855050-00018. PMID: 9585869. 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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