Test methods

We have developed the below test methods for the identification and determination of nitrosamine impurities in medicines. These test methods can be adapted and used by you to detect nitrosamine impurities in your products. The methods should be validated by you prior to its use to ensure they are suitable for your intended use. The methods may be subject to revisions if new information becomes available.

• Test method for determination of six nitrosamine impurities in western medicines by LC-MS228 KB

1. N-Nitroso-dimethylamine (NDMA)
2. N-Nitroso-diethylamine (NDEA)
3. N-ethyl-N-nitroso-2-propanamine (NEIPA)
4. N-nitroso-di-isopropylamine (NDIPA)
5. N-nitroso-di-n-butylamine (NDBA)
6. N-nitroso-N-methylamino butyric acid (NMBA)

• Test method for determination of N-Nitroso-dimethylamine (NDMA) in metformin and ranitidine products by LC-MS151 KB
• Test method for determination of N-Nitroso-dimethylamine (NDMA) in metformin products by HRAM-GCMS177 KB
• Test method for determination of 1-Methyl-4-Nitrosopiperazine (MNP) in rifampicin products by LC-MS/MS227 KB
• Test method for determination of N-Nitroso Salbutamol in salbutamol products by LC-MS/MS487 KB