Norfloxacin EP Impurity H also referred to in pharmacopoeias as Norfloxacin Related Compound H, 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 H (CAS No: 105440-01-5) or Norfloxacin N-Ethoxycarbonyl Impurity is an impurity present in the synthesis of Norfloxacin represents the first broad-spectrum fluoroquinolone that is usually used against urinary tract infections, it has been identified as the main product of its photodegradation.
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.?
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