Abacavir Carboxylate (CAS 384380-52-3) | também referido como Abacavir 5′-carboxilato ou Abacavir 5′-ácido carboxílico | é uma impureza de degradação com grupo carboxílico na posição 5′ que resulta da oxidação ou hidrólise do nucléosídeo parental; apresenta maior polaridade e comportamento cromatográfico distinto em cromatografia líquida | tornando-se um marcador crítico no perfil de impurezas. A caracterização analítica inclui LC-MS de alta resolução | NMR e comparações com padrão de referência para identificar massa e sinais químicos. Seu controle é essencial para garantir estabilidade e conformidade | exigindo métodos validados | limites estabelecidos e monitoramento durante desenvolvimento e validação de processo.
Referências
Ravitch, Joshua R., and Caroline G. Moseley. “High-Performance Liquid Chromatographic Assay for Abacavir and Its Two Major Metabolites in Human Urine and Cerebrospinal Fluid.” Journal of Chromatography B: Biomedical Sciences and Applications, vol. 762, no. 2, Oct. 2001, pp. 165–73, https://doi.org/10.1016/s0378-4347(01)00361-9.
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