Atorvastatin EP Impurity B (Free Base), CAS 842103-12-2, es una impureza sintética estructuralmente relacionada con la ruta de fabricación de atorvastatina cálcica y con la transformación de la cadena lateral de la estatina bajo condiciones de proceso o de estrés. Con fórmula molecular C33H35FN2O5 y peso molecular 558,65 g/mol, conserva el farmacóforo pirrol fluorofenilo, pero difiere del principio activo por la disposición estereoquímica o de sustituyentes, lo que modifica su comportamiento cromatográfico y el perfil de impurezas. Su determinación suele requerir LC en fase reversa con UV, LC-MS/MS o MS de alta resolución, además de NMR y, cuando procede, LC-ELSD o HPLC-UV para la cuantificación a nivel traza dentro de especificaciones regulatorias.
Referencias
McIver, L. A., & Siddique, M. S. (2022, September 2). Atorvastatin. Retrieved October 31, 2022, from Nih.gov website: https://www.ncbi.nlm.nih.gov/books/NBK430779/
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