Moxifloxacin 8-Hydroxy Quinolic Acid (CAS 154093-72-8) es una impureza hidroxi difluoro relacionada estructuralmente con Moxifloxacin | conocida también como Moxifloxacin Difluoro Hydroxy Impurity o Difluoro Hydroxy Gatifloxacin. Se identifica como producto de oxidación o degradación durante síntesis y estudios de estabilidad del principio activo. Desde el punto de vista analítico requiere técnicas HPLC | LC-MS y RMN para caracterización y cuantificación en el perfil de impurezas | debido a su similitud cromatográfica y espectral con el API. Su control en especificaciones y procedimientos de purificación es crítico para garantizar seguridad | eficacia y cumplimiento regulatorio.
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