Amlodipine EP Impurity C (dihidrocloruro) | CAS 2202710-78-7 | es una impureza derivada de la modificación bis(aminoetoxi) del núcleo 1 | 4-dihidropiridina que puede aparecer durante la síntesis de amlodipino; su nombre químico completo refleja grupos funcionales que influyen en polaridad | solubilidad y comportamiento de ionización. Su identificación y cuantificación se realizan típicamente por HPLC y LC-MS con confirmación por RMN | y el perfil analítico incluye retención | espectros de masas y datos de impurezas relacionadas. La comprensión de sus rutas de formación | estabilidad en medios ácidos y básicos y estrategias de control es esencial para cumplir especificaciones EP y minimizar su presencia en lotes.
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