(S)-4-[4-(Dimethylamino)-1-(4-fluorophenyl)-1-hydroxybutyl]-3-(hydroxymethyl)-benzonitrile Di-p-toluoyl-D-tartrate Salt
Sinónimos
Citalopram Dihydroxy Impurity
Descripción
La impureza relacionada Escitalopram Compuesto A (CAS 128173-53-5) | conocida también como Citalopram Dihydroxy Impurity | es un producto de oxidación de bajo peso molecular que puede formarse durante síntesis y almacenamiento del principio activo. Más polar que la API | presenta retos analíticos y requiere técnicas específicas para su identificación y cuantificación incluyendo HPLC con detección UV | LC-MS y RMN para confirmación estructural. Su presencia se controla mediante límites en el perfil de impurezas conforme a ICH Q3A/Q3B | estudios de estabilidad y optimización de condiciones de proceso. Ofrecemos especificaciones | datos analíticos y asesoría para la validación de métodos de ensayo.
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