Rosuvastatina impureza EP D, también denominada Rosuvastatina (3R,5S)-lactona o Rosuvastatina (5S)-lactona, CAS 503610-43-3, es un degradante lactónico del esqueleto de estatina formado por esterificación intramolecular de la cadena lateral hidroxicarboxílica. Esta impureza puede originarse por relactonización dependiente de pH y temperatura durante la síntesis, el almacenamiento o la degradación forzada. Con fórmula molecular C22H26FN3O5S y peso molecular 463,52 g/mol, mantiene gran similitud estructural con el fármaco parenta. Su detección y cuantificación suelen requerir LC-MS/MS, HPLC con detector de arreglo de diodos y, cuando se necesita resolución estereoquímica, LC quiral o RMN, dentro de marcos farmacopéicos de control de impurezas.
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