N-Desmethyl Rosuvastatin Lactone (CAS 1797419-58-9), también denominado N-desmethyl Rosuvastatin-5S-lactone, es una impureza relacionada con el proceso que se origina por N-desmetilación seguida de lactonización del núcleo del principio activo. Esta lactona muestra una masa molecular y propiedades fisicoquímicas distintas al API y puede influir en la pureza y estabilidad del lote. Su identificación y cuantificación requieren técnicas analíticas robustas como HPLC-UV, LC-MS y RMN para caracterización estructural y cuantificación trazable. El control en proceso, el perfil de degradación y la especificación de límites son esenciales para garantizar conformidad con requisitos regulatorios y asegurar calidad farmacéutica.
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