Our genotoxic impurity study services include:

  • Genotoxic impurity testing according to ICH M7 (R1), USFDA, EMA and/or customer requirements for Identification cum quantification.
  • We develop, validate and analyze the genotoxic impurities by considering allowable maximum daily exposure target.
  • volatile organic compounds and Nitrosamines evaluations like NMBA, NDMA NDIPA etc.
  • Techniques used are GC-MS/MS, HS-GC-MS, LC-MS/MS, ICP-MS, HPLC, and GC.
Previous project
Next project