(3R, 5S)-5-[(6R)-8-Fluoro-4-isopropyl-2-(N-methylmethylsulfonamido)-5, 6-dihydrobenzo[h]quinazolin-6-yl]-3, 5-dihydroxypentanoic acid sodium salt
Sinônimos
N/A
Descrição
Esta impureza estereoisomérica | Rosuvastatina (6R)-Isômero Sal de Sódio (CAS 854898-48-9) | representa um enantiômero crítico a ser monitorado durante síntese e purificação. Caracteriza-se por propriedades físico químicas e comportamento farmacocinético distintos que podem afetar pureza e perfil de segurança do produto final. Requer identificação e quantificação por técnicas quimioanalíticas sensíveis como HPLC quiral | LC-MS | RMN e testes de dissolução para definir limites de aceitação. Controle de processo | condições de racemização e validação analítica são essenciais para conformidade regulatória e especificações de qualidade. Estratégias de mitigação incluem otimização de etapas sintéticas | purificação cromatográfica e especificações de liberação.
Referências
Luvai, Ahai, et al. “Rosuvastatin: A Review of the Pharmacology and Clinical Effectiveness in Cardiovascular Disease.†Clinical Medicine Insights: Cardiology, vol. 6, Jan. 2012, p. CMC.S4324, https://doi.org/10.4137/cmc.s4324. ‌
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