Abacavir Related Compound B (CAS 141271-12-7) é uma impureza crítica associada ao processo de síntese do abacavir | caracterizada por perfis analíticos distintos que exigem controle rigoroso. Esta impureza é tipicamente detectada e quantificada por HPLC com detecção UV | confirmada por LC-MS para massa molecular e por RMN para elucidação estrutural. Estudos de estabilidade e de forçada degradação ajudam a definir suas vias de formação e limites de especificação. A disponibilidade de material de referência e métodos validados é essencial para monitoramento em lote a lote | investigação de desvios e conformidade com requisitos regulatórios de qualidade farmacêutica.
Referências
Hervey, Pauline S., and Caroline M. Perry. “Abacavir.†Drugs, vol. 60, no. 2, Aug. 2000, pp. 447–79, https://doi.org/10.2165/00003495-200060020-00015. Jain, Mohit, et al. “A Simple and Sensitive Method for the Ultra Trace Determination of Potential Genotoxic Impurities in Abacavir Sulfate by LC-MS.†Chemical Methodologies, vol. 2, no. 4, Sami Publishing Company, Oct. 2018, pp. 315–23, https://doi.org/10.22034/chemm.2018.66185.
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