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Test methods

Test methods to identify and determine nitrosamine impurities in medicines

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.

  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)
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