Abacavir EP Impurity A, CAS 136470-79-6, es una impureza de proceso estructuralmente definida asociada con el inhibidor nucleósido de la transcriptasa inversa abacavir. Con fórmula molecular C14H18N6O y peso molecular de 286.33 g/mol, corresponde a un análogo heteroaromático aminado cuya presencia suele interpretarse como derivada de intermedios sintéticos o de reacciones laterales durante la construcción del andamiaje con triazina. Su asignación estructural y cuantificación a niveles traza suelen requerir LC-MS/MS, LC-MS de alta resolución y métodos ortogonales de HPLC o UPLC con detección UV. En el ámbito regulatorio, se evalúa como sustancia relacionada y, cuando aplica, por posible riesgo mutagénico conforme a ICH M7.
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. ?Vukkum, Pallavi. “Stress Degradation Behavior of Abacavir Sulfate and Development of a Suitable Stability-Indicating UHPLC Method for the Determination
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