Norfloxacin EP Impurity A also referred to in pharmacopoeias as Norfloxacin Related Compound A, is a meticulously characterized reference standard. It adheres to stringent regulatory guidelines, including those established by USP, EMA, JP, and BP. This product plays a vital role in Abbreviated New Drug Applications (ANDA), New Drug Applications (NDA), and the commercial manufacturing of Norfloxacin. Furthermore, it is accompanied by a comprehensive Structure Elucidation Report (SER), ensuring its accuracy and reliability across various analytical applications. Norfloxacin EP Impurity A (CAS No: 68077-26-9) is an impurity present in the synthesis of Norfloxacin which is an oral fluoroquinolone antibacterial, is active in vitro against a variety of gram-positive and gram-negative pathogens, used in the treatment for uncomplicated gonococcal infection.
References
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 Kaplowitz, Lisa G., et al. “Norfloxacin in the Treatment of Uncomplicated Gonococcal Infections.†The American Journal of Medicine, vol. 82, no. 6, June 1987, pp. 35–39, https://doi.org/10.1016/0002-9343(87)90616-4.?
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