Levofloxacin Related Compound F; 9-Desfluoro; (3S)-2, 3-Dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1, 2, 3-de]-1, 4-benzoxazine-6-carboxylic Acid; Levofloxacin Related Compound F (USP), Levofloxacin USP Related Compound F
Descripción
Levofloxacin EP Impurity D (CAS 117620-85-6) | conocida también como Levofloxacin Related Compound F o 9-Desfluoro | es una impureza estructural relevante en los perfiles de calidad de levofloxacino. Su presencia como producto intermedio o degradado requiere identificación y cuantificación precisas mediante HPLC con detección UV | confirmación por espectrometría de masas y caracterización por RMN. Se controla en especificaciones farmacéuticas por su impacto potencial en la pureza y estabilidad; se recomienda el uso de estándares de referencia certificados | límites de aceptación basados en riesgos | validación de métodos analíticos y documentación según monografías EP y USP para garantizar cumplimiento regulatorio y consistencia del control de calidad.
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