Abacavir EP Impurity E (CAS 208762-35-0) é uma impureza estrutural relacionada ao abacavir | identificada como [(1R | 3S)-3-[2-amino-6-(cyclopropylamino)purin-9-yl]cyclopentyl]metanol e também referida como Dihydro Abacavir e Abacavir Impurity E | cuja presença impacta o perfil de pureza do API; sua quantificação e identificação exigem métodos analíticos validados | tipicamente HPLC com detecção UV e confirmação por LC-MS para massa e fragmentação. Avaliação das vias de formação | estabilidade sob condições de síntese e armazenamento | limites de aceitação e estratégias de redução ou remoção são essenciais para o controle de qualidade e conformidade com monografias farmacêuticas.
Referências
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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