Clorabacavir Racemic (CAS 1918156-05-4) é uma impureza sintética crítica encontrada em processos de produção que requer caracterização analítica rigorosa. Sua identificação e quantificação por HPLC e LC-MS são essenciais para estabelecer o perfil de pureza e detectar variações de síntese | subprodutos e produtos de degradação. Propriedades fisicoquímicas e vias de degradação influenciam estabilidade e limites de aceitação | especialmente quando há risco de impurezas genotóxicas. Estratégias de controle incluem otimização de rota sintética | purificação cromatográfica e validação analítica com limites de detecção e recuperação estabelecidos. Documentação de conformidade regulatória e monitoramento contínuo garantem qualidade e segurança do lote.
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.â€Â Scientia Pharmaceutica, vol. 80, no. 4, 2012, pp. 903–21, https://doi.org/10.3797/scipharm.1206-11.
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