Eltrombopag Impurity 12 (CAS 893736-72-6) | conocida también por los sinónimos 3-(2-hidroxifenil)benzoic acid y [1 | 1′-biphenyl]-3-carboxylic acid | 2′-hydroxy- | es una impureza estructural derivada del esqueleto bifenílico del principio activo. Presenta características ácidas y aromáticas que facilitan su separación por HPLC y su confirmación mediante LC-MS y resonancia magnética nuclear. Se forma típicamente por reacciones de desprotección o oxidación durante la síntesis y puede impactar en la pureza del lote si no se controla. El monitoreo cuantitativo | límites específicos en especificaciones y estrategias de purificación son esenciales para asegurar cumplimiento regulatorio y calidad del producto.
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