A impureza (4R-cis)-6-Clorometil-2 | 2-dimetil-1 | 3-dioxano-4-acético éster tert-butilo (CAS 154026-94-5) é um subproduto crítico no processo de síntese do intermediário | com propriedades lipofílicas que afetam separação e purificação; sua presença pode reduzir rendimento e alterar o perfil de impurezas do lote. Exige monitorização analítica robusta por HPLC com DAD/MS e confirmação por espectrometria de massas e RMN | além de estudos de estabilidade para avaliar formação por cloração secundária e transesterificação. Estabelecer limites de especificação | procedimentos de amostragem e estratégias de remediação é essencial para controle de qualidade e conformidade regulatória.
Referências
Luvai, A., Mbagaya, W., Hall, A. S., & Barth, J. H. (2012). Rosuvastatin: A Review of the Pharmacology and Clinical Effectiveness in Cardiovascular Disease. Clinical Medicine Insights: Cardiology, 6, CMC.S4324. https://doi.org/10.4137/cmc.s4324
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