N-nitrosamines Testing
SGS Polymer Solutions (SGS PSI) provides testing of n-Nitrosamines in polymers, drugs and other consumer products.
SGS Polymer Solutions (SGS PSI) provides testing of n-Nitrosamines in polymers, drugs and other consumer products.
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.
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.
Contact us to discuss your specific sample requirements for N-nitrosamine testing.
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)
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