La impureza (3R | 5R)-Atorvastatin Amide | CAS 2125501-02-0 | representa un degradado estereoespecífico relevante en el control de calidad de atorvastatina; se caracteriza por un patrón cromatográfico definido en HPLC con retención intermedia respecto al principio activo y un espectro de masas que evidencia fragmentación típica del análogo amídico. Su identificación requiere LC-MS de alta resolución y confirmación por RMN 1H/13C | con límites de detección en microgramos por mililitro y cuantificación por método validado conforme a ICH Q2. La ruptura de enlaces amídicos durante la síntesis y condiciones de almacenamiento acuosas favorecen su formación | por lo que se recomienda monitorizar perfiles de impurezas y establecer especificaciones para garantizar estabilidad y seguridad.
Referencias
McIver, Lindsey A., and Momin S. Siddique. “Atorvastatin.” Nih.gov, StatPearls Publishing, 15 May 2022, www.ncbi.nlm.nih.gov/books/NBK430779/.
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