Impureza Rosuvastatina Isoamy Ester é um éster relacionado à rosuvastatina identificado como subproduto crítico durante síntese e armazenamento do API | CAS 1197348-98-3. Sua formação está associada a reações de esterificação | transesterificação e hidrólise parcial sob variações de solvente | pH e temperatura. Técnicas analíticas robustas como HPLC com detecção UV | LC-MS e RMN são essenciais para caracterização | quantificação e estabelecimento de limites de especificação conforme diretrizes ICH. Do ponto de vista de controle de qualidade | a presença desta impureza pode afetar pureza | estabilidade e perfil toxicológico | sendo mitigada por otimização de processo | purificação cromatográfica e monitoramento em processo.
Referências
Guan, Yong-Song, et al. “Role of Gefitinib in the Targeted Treatment of Non-Small-Cell Lung Cancer in Chinese Patients.†OncoTargets and Therapy, Mar. 2016, p. 1291, https://doi.org/10.2147/ott.s80635. ‌
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