Atorvastatin Related Compound B (CAS 887196-25-0) | conocido como Atorvastatin EP Impurity B calcio o isómero (3S | 5R) en sal cálcica | es una impureza estereoquímica relevante en el desarrollo y control de calidad de materias primas de atorvastatina. Su estructura | 7-(2-(4-fluorofenil)-3-fenil-4-(fenilcarbamoil)-5-propan-2-ilpirrol-1-il)-3 | 5-dihidroxiheptanoato | exige técnicas analíticas robustas para identificación y cuantificación | incluyendo HPLC con detectores UV y MS | RMN y ensayo de perfil de impurezas. La caracterización completa permite establecer límites de especificación | optimizar procesos de síntesis y formular estrategias de eliminación y monitorización conforme a requisitos regulatorios.
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