Citalopram R-Isomer (Oxalate Salt) (CAS 219861-53-7) | denominado Escitalopram EP Impurity K | es una impureza estereoquímica crítica que representa el isómero R en formulaciones de escitalopram. Su presencia afecta la pureza enantiomérica y requiere monitorización estricta conforme a guías regulatorias ICH para impurezas y control de calidad. La identificación y cuantificación se realizan mediante HPLC quiral | LC-MS y RMN para asegurar trazabilidad y especificidad | y se emplean estándares de referencia para establecer límites de aceptación y procedimientos de liberación de lote. Los estudios de estabilidad | perfil de degradación y control de proceso son esenciales para mitigar su formación.
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