Impureza H de Norfloxacino (CAS 105440-01-5) | también conocida como Norfloxacin Related Compound H o Norfloxacin N-Ethoxycarbonyl Impurity | es un contaminante clave en perfiles de pureza del principio activo. Su identificación y cuantificación mediante HPLC | cromatografía de gases cuando procede | y espectrometría de masas es esencial para garantizar la conformidad con especificaciones farmacéuticas. Disponible como estándar de referencia | facilita validación de métodos | determinación de límites de impureza y estudios de degradación forzada. Características analíticas | retención | espectros UV y masa | así como comportamiento en condiciones de estrés | son parámetros críticos para el control de calidad y la evaluación toxicológica en el desarrollo y loteo.
Referencias
Mielji, Branislava, et al. “Column High-Performance Liquid Chromatographic Determination of Norfloxacin and Its Main Impurities in Pharmaceuticals.†Journal of AOAC INTERNATIONAL, vol. 91, no. 2, Mar. 2008, pp. 332–38, https://doi.org/10.1093/jaoac/91.2.332.?
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