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Services

Unknown Impurity Identification

"Subtle Pharma" believe that research lies at the heart of progress. We have strengthened our commitment towards identification, isolation and characterization of unknown impurities. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), Europe Middle East & Africa (EMEA) and the International Congress on Harmonization (ICH) have established rigorous guidelines for the identification of extraneous compounds in pharmaceutical agents.

    Subtle Follows

  • The structure of the unknown impurity will be identified with the use of modern hyphenated techniques like, FT-IR, NMR (Which includes 1H-NMR and 13C-NMR) and Mass spectra
  • If possible, conclusion will be drawn from HPLC method for spectral information.
  • We will check the possibility of converting HPLC method into LCMS method.
  • Using general screening methods, impurities present in the drug product will be determined at trace levels.
  • A final confirmation will be done in the HPLC-UV chromatography method by retention match between the drug product impurity and the analytical standard.
  • Identified unknown impurities structure will be supported with raw datas.