Nitrosamines & NDSRIs Studies

We Perform Genotoxic Impurity Study Testing On:

  • Active Pharmaceutical Ingredients (APIs) / Drug Substance
  • Drug Products (Tablets, Capsules, Injectables, Ointments, Lotions, Syrups, Suspensions, Gels, Inhalations, Creams & Emulsion, Transdermal Patches etc.,)



Our Genotoxic & Nitrosamine Impurity Services Include:

  • Genotoxic impurity testing according to ICH M7 (R1), USFDA, EMA and/or customer requirements for Identification & quantification.
  • We develop, validate and analyse the genotoxic impurities by considering allowable maximum daily exposure target achieving stringent LOQ requirements.
  • Techniques used are LCMS/MS, GC-MS/MS,