Abacavir EP Impurity F (CAS 1443421-68-8) é uma impureza estrutural do abacavir caracterizada pelo grupo tert-butoximetil no anel ciclo-pentênico | resultando em um derivado t-butilo identificado como O-t-Butyl Derivative Abacavir. Esta impureza pode originar-se durante etapas de proteção ou eterificação e altera polaridade e massa molecular relativa | sendo detectável e quantificável por técnicas cromatográficas e espectrométricas como HPLC | LC-MS e RMN. A sua presença é relevante para o perfil de pureza e desenvolvimento analítico | exigindo metodologias validadas para separação | quantificação e caracterização estrutural | incluindo avaliação de risco toxicológico e limites de especiação.
Referências
Vukkum, Pallavi. “Stress Degradation Behavior of Abacavir Sulfate and Development of a Suitable Stability-Indicating UHPLC Method for the Determination of Abacavir, Its Related Substances, and Degradation Products.” Scientia Pharmaceutica, vol. 80, no. 4, 2012, pp. 903–21, https://doi.org/10.3797/scipharm.1206-11.
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