Abacavir Related Compound C (CAS 172015-79-1) é uma impureza relacionada estruturalmente ao derivado cloropurina do abacavir | identificada como [(1S | 4R)-4-(2-amino-6-cloro-9H-purin-9-yl)cyclopent-2-en-1-yl]methanol hydrochloride. Como impureza de síntese | apresenta risco potencial à qualidade e à segurança do ingrediente farmacêutico ativo se não for controlada | sendo tipicamente formada por reações secundárias durante a cloração ou etapas de purificação. O controle analítico recorre a HPLC | LC-MS e RMN para caracterização e quantificação | com limites estabelecidos conforme guias ICH de perfil de impurezas e estudos de estabilidade para monitoramento em processo e no produto acabado.
Referências
?Canoa, Pilar, et al. “Synthesis and Anti-HIV Activity of Novel Cyclopentenyl Nucleoside Analogues of 8-Azapurine.” Chemical and Pharmaceutical Bulletin, vol. 54, no. 10, 2006, pp. 1418–20, https://doi.org/10.1248/cpb.54.1418. ?
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