Impureza 4 de Argatroban (CAS 153886-68-1) | también conocida como 1 | 2 | 3 | 4-Tetrahydro-3-methyl-8-quinolinesulfonic acid | es una impureza estructuralmente relacionada que incorpora un núcleo tetrahidroquinolina con un grupo sulfónico y un sustituyente metilo en la posición 3. Su carácter ácido y su alta polaridad influyen en su comportamiento en cromatografía líquida y en su ionización en espectrometría de masas | por lo que se recomienda su monitoreo mediante HPLC/UV y LC-MS con métodos validados. El control de esta impureza es crítico para garantizar la pureza del material activo; se deben definir límites | estrategias de eliminación y perfiles por RMN para aceptación del lote.
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