Impureza Rosuvastatina (6S)-Lactona | CAS 854898-47-8 | es una lactona derivada de la ciclización intramolecular de la rosuvastatina que puede formarse durante etapas de síntesis | purificación o almacenamiento. Su identificación y cuantificación son esenciales en el control de calidad por su impacto potencial en la pureza y estabilidad del ingrediente activo. Caracterización analítica mediante HPLC | LC-MS y RMN proporciona perfil cromatográfico | masa molecular y confirmación estructural. Se recomienda monitoreo proactivo de parámetros de proceso y condiciones de formulación para minimizar su aparición | además de estudios de degradación forzados para definir límites aceptables y estrategias de mitigación.
Referencias
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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