Revision of the EMA Guideline on Nitrosamines
In the new revision of the EMA document, new nitrosamines and new limits for others have been introduced.
Since the first discovery in 2018, the European Medicines Agency (EMA) has drawn up a series of documents and guidelines in order to prevent the uncontrolled presence of nitrosamines in medicines for human use. The intake of medicines containing this type of substance has in fact been linked, if not controlled, to the development of oncological diseases.
The document is being updated in real time by the EMA, with the help of the CHMP, in order to prevent or limit the presence of nitrosamines and to improve the manufacturing process of drugs.
With the new revision, dated 20 November 2023, new chemicals have been added to the list and the limits for some existing ones have been updated, below is the table with the new nitrosamines:
| N-Nitrosamine (CAS Number) | AI (ng/day) | Source |
|---|---|---|
| 5-chloro-4-methyl-2-[(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]-1H-benzimidazole | 1500 | Daridorexant |
| N-nitroso-ambroxol | 1500 | Ambroxol |
| N-nitroso-calcium folinate | NMI | Calcium folinate/ Calcium levofolinate |
| N-nitroso-celiprolol | 1500 | Celiprolol |
| N-nitroso-desethyllidocaine | 100 | Lidocaine |
| N-nitroso-desmethyl-azelastine | 100 | Azelastine |
| N-nitroso-desvenlafaxine | 18 | Desvenlafaxine |
| N-nitroso-dorzolamide | 100 | Dorzolamide |
| N-nitroso-esmolol | 1500 | Esmolol |
| N-nitroso-ethylenediamine-triacetic acid | 1500 | Isosorbide mononitrate |
| N-nitroso-iminodiacetic acid | 1500 | Isosorbide mononitrate |
| N-nitroso-indapamide | 1500 | Indapamide |
| N-nitroso-leniolisib | 1500 | Leniolisib |
| N-nitroso-N-methylaniline | 100 | - |
| N-nitroso-tetracaine | 400 | Tetracaine |
| N-Nitroso-ticagrelor | 1500 | Ticagrelor |
LabAnalysis has already developed and validated several matrix-specific methods [LC-HRMS, LC-MS/MS, GC-MS/MS] for some of the new nitrosamines targeted by the European Medicines Agency (EMA). The laboratory makes its expertise available to search for API-specific and generic nitrosamines on all kinds of products.
If you would like to learn more about this topic, we recommend you read the news that reports the FDA guidelines, as well as those of the EMA.
For more information contact
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