About N-nitrosamines Testing

N-nitrosamines are a class of organic compounds having a chemical structure of R2N-N=O. They are normally produced by the reaction of secondary amines and nitrous acid. They can be formed in the compounding of rubber materials and other polymers. N-nitrosamines can also be found as impurities in pharmaceuticals as well as other consumer goods.

  • Approaches

    The testing of N-nitrosamines may be a two-step process. The first step would be identification of N-nitrosamines. The second step would consist of quantitation of the N-nitrosamines that were identified in the first step. If your N-nitrosamines of interest have already been identified then quantitation would be the only step needed.

    Liquid Chromatography with Mass Spectrometry (LC/MS) is the method that would be used most often. Gas Chromatography with Mass Spectrometry (GC/MS) may also be used in the identification phase of the testing.

    List of possible N-nitrosamines that SGS PSI can quantify:
    N-Nitrosodimethylamine (NDMA) - Cas. No. 62-75-9
    N-Nitrosomethyletylamine (NMEA) – Cas. No. 10595-95-6
    N-Nitrosodiethylamine (NDEA) – Cas. No. 55-18-5
    N-Nitrosodi-n-propylamine (NDPA) – Cas. No. 621-64-7
    N-Nitrosopiperidine (NPIP) – Cas. No. 100-75-5
    N-Nitrosopyrrolidine (NPYE) – Cas. No. 930-5-2
    N-Nitrodi-n-butylamine (NDBA) – Cas. No. 924-16-3
    N-Nitroso-N-methyl-4-aminobutyric Acid (NMBA)- Cas. No. 61445-55-4
    Nitrosomorpholine – Cas. No. 59-89-2

    Method validation can be provided for your material.
     

  • Sample Considerations

    Contact us to discuss your specific sample requirements for N-nitrosamine testing. 

  • Experience

    SGS PSI has performed N-nitrosamine testing on drug products. This includes identification and quantification. All testing is performed in our cGMP compliant, FDA registered laboratory. 


    Related Services
    Chromatography
    Liquid Chromatography with Mass Spectrometry (LC/MS)
    Gas Chromatography with Mass Spectrometry (GC/MS)
    Quality Assurance