Escitalopram Impurity J | identificado como ácido p-toluenesulfónico (CAS 104-15-4) | es una impureza orgánica comúnmente detectada como contraión o subproducto de síntesis en lotes de escitalopram. Se caracteriza por su acidez fuerte | polaridad elevada y tendencia a formar sales | lo que puede alterar solubilidad y perfil de liberación. Su detección y cuantificación se realiza por HPLC con detección UV | LC-MS y confirmación mediante RMN e IR. Su control se logra por purificación por extracción | recristalización o intercambio iónico y por límites específicos en especificaciones analíticas validadas. La monitorización continua asegura cumplimiento de requisitos regulatorios y estabilidad del producto final.
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