In collaboration with regulatory counterparts around the world, US FDA has set internationally-recognized acceptable daily intake limits for nitrosamines. Suppose drugs contain levels of nitrosamines above the acceptable daily intake limits. In that case, FDA recommends these drugs be recalled by the manufacturer as appropriate or not be released for distribution to the market.

FDA has identified seven nitrosamine impurities that theoretically could be present in drug products: NDMA, N-nitrosodiethylamine (NDEA), N-nitroso-N-methyl-4-aminobutanoic acid (NMBA), N-nitrosoisopropylethyl amine (NIPEA), N-nitrosodiisopropylamine (NDIPA), N-nitrosodibutylamine (NDBA), and N-nitrosomethylphenylamine (NMPA). Five (NDMA, NDEA, NMBA, NIPEA, and NMPA) have been detected in drug substances or products.

Services provided by IAS for Nitrosamine Impurities:
  • Risk Assessment Study for Nitrosamine Impurities in Drug Substance and Drug Product
  • Analytical Method Development and Validation for Quantitation of Nitrosamine Impurities in Drug Substance and Drug Product
  • Batch Analysis
Instruments available at IAS
  • LCMS (Make :- Sciex, Shimadzu, Waters)
  • GCMS (Make :- Shimadzu)