Tert-Butyl (3S | 5S)-6-Chloro-3 | 5-dihydroxyhexanoate (CAS 325471-28-1) é uma impureza quimicamente definida | relevante em controlos de qualidade de sínteses complexas. Caracteriza-se por elevada polaridade relativa e grupos hidroxila vicinais que afetam sua solubilidade e retenção em análises cromatográficas. Pode originar-se por cloração incompleta ou reações secundárias durante etapas de proteção/desproteção. A sua presença influencia perfil de pureza | rendimento e estabilidade do lote. Métodos recomendados para identificação e quantificação incluem HPLC com detecção UV/ELSD | LC-MS e espectroscopia NMR para confirmação estrutural. Procedimentos de controlo incluem limites especificados | amostragens representativas e condições de armazenamento anidro e refrigerado.
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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