Impureza Atorvastatin Diepoxide Lactone es una impureza derivada del proceso de síntesis y degradación de atorvastatina | relevante para el control de calidad en producción farmacéutica. Su perfil químico incluye una estructura lactona diepóxido que puede afectar la pureza del lote | la estabilidad y la respuesta a pruebas analíticas. La identificación y cuantificación requieren métodos validados | típicamente HPLC con detección UV o LC-MS para trazabilidad y cumplimiento regulatorio. Evaluaciones de impureza | límites de aceptación | estudios de degradación forzada y perfiles de impurezas relacionadas permiten mitigar riesgos en formulación y garantizar conformidad con especificaciones y buenas prácticas de fabricación.
Referencias
McIver, Lindsey A., and Momin S. Siddique. “Atorvastatin.” Nih.gov, StatPearls Publishing, 5 Jan. 2019, www.ncbi.nlm.nih.gov/books/NBK430779/. Ramkumar, Satish, et al. “Statin Therapy: Review of Safety and Potential Side Effects.” Acta Cardiologica Sinica, vol. 32, no. 6, Taiwan Society of Cardiology, 2016, pp. 631–39, https://doi.org/10.6515/ACS20160611A.
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