La impureza 245 de rosuvastatina (CAS 147118-41-0) es un subproducto identificado en estudios de perfil de impurezas durante la fabricación y la estabilidad del principio activo. Presenta modificaciones estructurales respecto al API, habitualmente observada como isómero o derivado de degradación, y puede formarse por rutas cinéticas durante etapas de síntesis o por condiciones adversas de almacenamiento. Su detección y cuantificación se realizan por HPLC con detección UV y se confirma por LC-MS, complementada por espectroscopía de RMN para elucidación estructural. La monitorización rigurosa y límites de aceptación basados en guías ICH son esenciales, junto con medidas de mitigación en síntesis y purificación.
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