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,
  HS-GC-MS/MS,