Atorvastatin Diepoxide es una impureza relacionada | identificada también como Atorvastatin Dihydroxy Diepoxide impurity (free acid) | que surge por epoxidación no deseada del núcleo dihidroxitriol de atorvastatina y subsecuente hidrólisis a dihidroxidiepóxido. Desde el punto de vista técnico afecta estabilidad y perfil de degradación del lote | exige monitoreo en estudios acelerados y pruebas de liberación. Se caracteriza por cromatografía líquida de alta resolución LC HPLC y confirmación por LC MS y RMN | presenta distinta polaridad y retención frente al API. El control se implementa mediante límites de especificación basados en ICH Q3B | procedimientos de purificación y condiciones de proceso optimizadas para minimizar su formación.
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