Nitrosamine structures can be accessed by clicking the hyperlink embedded in the table or available to download as a printable version below.
Note: The hyperlink directs to an external webpage whose content is not managed by the TGA.
N-Nitroso-structures that include N-nitrosoguanidines, N-nitroso-indoles and N-nitrosoureas impurities are listed separately, see Established acceptable intake for other nitroso-structures in medicines.
A revision table listing updates to the AI limit information for nitrosamines and other N-nitroso-structures is available at Updates to nitrosamines and other nitroso-structures.
Established acceptable intake for nitrosamines in medicines
| Nitrosamine | CAS No, abbreviations | Source* | AI limit (ng/day)** | CPCA Potency category | Date published (YYYY-MM-DD) | Date/s updated (YYYY-MM-DD) |
|---|---|---|---|---|---|---|
| N-Nitroso-abacavir | Abacavir | 1500 | 5 | 2026-08-14 | ||
| N-Nitroso-acarbose | Acarbose | 1500 | 5 | 2025-07-31 | ||
| N-Nitroso-acebutolol | Acebutolol | 1500 | 4 | 2024-10-15 | ||
| N-Nitroso-2-(7-methoxy-1-naphthyl)-N-[2-(7-methoxy-1-naphthyl)ethyl]ethylamine | Agomelatine | 100 | 2 | 2024-07-29 | ||
| N-Nitroso-desmethyl-almotriptan | Almotriptan | 18 | 1 | 2025-11-03 | ||
| 3-Amino-N-nitrosopiperidine | 2819242-71-0 | Alogliptin | 400 | 3 | 2023-10-16 | |
| N-Nitroso-alprazolam EP Impurity H | Alprazolam | 1500 | 2026-08-14 | |||
| N-Nitroso-ambroxol | Ambroxol | 1500 | 2023-08-24 | 2024-01-31 | ||
| N-Nitroso-N-desethyl-amiodarone | 678982-38-2 | Amiodarone | 18 | 1 | 2025-11-03 | |
| N-Nitroso-nortriptyline | 55855-42-0, NNORT | Amitriptyline, Nortriptyline | 18 | 1 | 2022-07-20 | 2024-10-15 |
| N-Nitroso-methylethylamine | 10595-95-6, NMEA | Amphotericin B | 26.5 | 2026-08-14 | ||
| N-Nitroso-apixaban impurity B | Apixaban | 1500 | 4 | 2024-04-24 | ||
| 1-(2,3-Dichlorophenyl)-4-nitrosopiperazine | 2989508-28-1 | Aripiprazole | 400 | 3 | 2024-01-31 | |
| N-Nitroso-praziquanamine | 115822-46-3 | Arpraziquantel | 1500 | 4 | 2023-08-24 | |
| N-Nitroso-articaine+A14 | Articaine | 1500 | 4 | 2024-07-29 | ||
| N-Nitroso-atenolol | 134720-04-0 | Atenolol | 1500 | 4 | 2023-08-24 | |
| N-Nitroso-atomoxetine | Atomoxetine | 100 | 2023-08-24 | |||
| N-Nitroso-azacyclonol | 1038-06-8 | Azacyclonol | 400 | 3 | 2024-01-31 | |
| N-Nitroso-desmethyl-azelastine | Azelastine | 100 | 2 | 2024-01-31 | ||
| N-Nitroso-azithromycin | Azithromycin | NMI | 2023-08-24 | |||
| N-Nitroso-desmethylazithromycin | Azithromycin | NMI | 2023-08-24 | |||
| N-Nitroso-benazepril | Benazepril | 1500 | 5 | 2023-08-24 | ||
| N-Nitroso-benzathine | Benzathine | 18 | 1 | 2025-07-31 | ||
| 3-(Dimethylamino)propyl 2-[benzyl(nitroso)amino]benzoate | 3DPN | Benzydamine | 1500 | 2024-07-29 | 2026-08-14 | |
| N-Nitroso-berotralstat | Berotralstat | 1500 | 2025-11-03 | 2026-01-29 | ||
| N-Nitroso-betahistine | 32635-81-7 | Betahistine | 18 | 1 | 2023-08-24 | |
| N-Nitroso-betaxolol | Betaxolol | 1500 | 4 | 2024-01-31 | ||
| N-Nitroso-bilastine impurity 2 | Bilastine | 400 | 3 | 2024-07-29 | ||
| N-Nitroso-bisoprolol | 2820170-76-9, NBP | Bisoprolol | 1500 | 4 | 2023-08-24 | |
| 3-((Ethyl(nitroso)amino)methyl) benzenesulfonate | N-M8 | Brilliant blue FCF | 18 | 1 | 2024-07-29 | |
| N-Nitroso-brinzolamide | Brinzolamide | 100 | 2 | 2025-07-31 | ||
| N-Nitroso-bumetanide | 2490432-02-3, NNB | Bumetanide | 1500 | 2023-08-24 | 2026-01-29 | |
| N-Nitroso-2,6-pipecoloxilidide / desbutyl bupivacaine nitroso impurity | 3035512-94-5 | Bupivacaine | 1500 | 4 | 2025-11-03 | |
| N-Nitroso-bupropion | 2763780-10-3 | Bupropion | NMI | 2023-08-24 | 2025-02-04 | |
| N-Nitroso-buspirone Impurity 1 | 872826-80-7 | Buspirone | 400 | 3 | 2024-10-15 | |
| N-Nitroso-desmethyl-cabergoline | Cabergoline | 18 | 1 | 2025-04-30 | ||
| N-Nitroso-calcium folinate | Calcium folinate / Calcium levofolinate | NMI | 2024-01-31 | |||
| N-Nitroso-carvedilol | 2248746-67-8 | Carvedilol | 400 | 3 | 2025-07-31 | |
| N-Nitroso-caspofungin | Caspofungin | 1500 | 4 | 2024-07-29 | ||
| N-Nitroso-celiprolol | Celiprolol | 1500 | 5 | 2024-01-31 | ||
| N-Nitroso-desmethyl-chloropyramine | N-DMCP | Chloropyramine | 18 | 1 | 2023-08-24 | |
| N-Nitroso-p-chloro-benzylamino-pyridine | N-CBAP | Chloropyramine | 100 | 2 | 2023-08-24 | |
| N-Nitroso-desmethyl-chlorphenamine | Chlorphenamine | 18 | 1 | 2025-02-04 | ||
| N-Nitroso-cilazapril | 1053740-92-3 | Cilazapril | 1500 | 5 | 2023-08-24 | |
| N-Nitroso-cinacalcet | Cinacalcet | 400 | 3 | 2024-01-31 | ||
| 1-Diphenylmethyl-4-nitrosopiperazine | 1698-25-5 | Cinnarizine | 400 | 3 | 2024-07-29 | |
| N-Nitroso-ciprofloxacin | 864443-44-7 | Ciprofloxacin | NMI | 2023-08-24 | 2024-10-15 | |
| N-Nitroso-desmethyl-citalopram | Citalopram | 100 | 2024-01-31 | 2024-07-29 | ||
| N-Nitroso-N-desmethyl-clarithromycin | Clarithromycin | NMI | 2024-07-29 | |||
| N-Nitroso-clozapine | 156632-03-0 | Clozapine | 1500 | 5 | 2024-04-24 | |
| N-Nitroso-clozapine EP Impurity C | Clozapine | 400 | 3 | 2024-04-24 | ||
| N-Nitroso-2,4-thiazole amine | NNTA | Cobicistat | 18 | 1 | 2025-11-03 | |
| N-Nitroso-didecylamine | Colesevelam | 100 | 2 | 2025-02-04 | ||
| 2,2,5-Trimethyl-3-nitroso-1,3-oxazolidine | 77400-46-5, TMNO | Cyanocobalamine | 1500 | 4 | 2024-04-24 | |
| N-Nitroso-cytisine | 19634-60-7 | Cytisine | 400 | 3 | 2026-01-29 | |
| N-Nitroso-dabigatran etexilate | NDAB | Dabigatran etexilate | 1500 | 2023-01-05 | 2024-04-24; 2023-08-24 | |
| N-Nitroso-dabigatran etexilate amide | NNDH | Dabigatran etexilate | 1500 | 2026-08-14 | ||
| N-Nitroso-dalbavancin | Dalbavancin | 1500 | 4 | 2025-04-30 | ||
| (2S,4R)-N-(6-Bromopyridin-2-yl)-4-fluoro-1-nitrosopyrrolidine-2-carboxamide | Danicopan | 1500 | 4 | 2025-11-03 | ||
| 5-Chloro-4-methyl-2-[(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]-1H-benzimidazole | IDOR-1135-8758 | Daridorexant | 1500 | 5 | 2024-01-31 | |
| N-Nitroso-dasatinib | Dasatinib | 1500 | 5 | 2025-04-30 | ||
| N-Nitroso-N-deshydroxyethyl-dasatinib | 2135905-86-9 | Dasatinib | 400 | 3 | 2025-02-04 | |
| N-Nitroso-desloratadine | 1246819-22-6 | Desloratadine | 400 | 3 | 2023-08-24 | |
| N-Nitroso-desvenlafaxine | Desvenlafaxine | 18 | 1 | 2024-01-31 | ||
| N-Nitroso-N-desmethyl dextromethorphan | N-DEX | Dextromethorphan | 1500 | 4 | 2024-07-29 | |
| N-Nitroso-diazepam Impurity D | 51145-18-7 | Diazepam | 100 | 2 | 2026-08-14 | |
| N-Nitroso-diclofenac | 66505-80-4 | Diclofenac | 78000 | 2023-08-24 | 2024-10-15 | |
| N-Nitroso?N-desmethyl?diltiazem | 3036581-85-5 | Diltiazem | 100 | 2025-11-03 | ||
| N-Nitroso-desmethyl-dimetindene | NO-DDMT | Dimetindene | 18 | 1 | 2024-10-15 | |
| N-Nitroso-N-desmethyl-diphenhydramine | 55855-43-1 | Diphenhydramine / Dimenhydrinate | 100 | 2024-07-29 | 2026-01-29 | |
| N-Nitroso-doravirine dimer | NDD | Doravirine | 1500 | 2025-11-03 | ||
| N-Nitroso-dorzolamide | Dorzolamide | 1500 | 2024-01-31 | |||
| N-Nitroso-desmethyl-cidoxepin | Doxepin | 18 | 1 | 2026-08-14 | ||
| N-Nitroso-desmethyl-doxycycline | Doxycycline | 400 | 3 | 2026-08-14 | ||
| N-Nitroso-desmethyl-doxylamine | Doxylamine | 100 | 2025-11-03 | |||
| N-Nitroso-desbutyldronedarone | Dronedarone | 1500 | 2026-08-14 | |||
| N-Nitroso-duloxetine | 2680527-91-5, NDLX | Duloxetine | 100 | 2022-07-20 | ||
| N-Nitroso-desmethyl-edoxaban | Edoxaban | 100 | 2 | 2024-07-29 | ||
| N-Nitroso-elagolix | Elagolix | 1500 | 4 | 2026-01-29 | ||
| N-Nitroso-desmethyl-eletriptan | Eletriptan | 1500 | 4 | 2025-02-04 | ||
| N-Nitroso-enalapril | Enalapril | 1500 | 5 | 2023-08-24 | ||
| N-Nitroso-diethylamine | 55-18-5, NDEA | Entacapone | 26.5 | 2025-11-03 | ||
| N-Nitroso-ephedrine | Ephedrine | 1500 | 4 | 2026-01-29 | ||
| N-Nitroso-epinephrine / N-nitroso-adrenaline | 3006789-99-4 | Epinephrine / Adrenaline | 100 | 2 | 2025-02-04 | |
| 6-Nitro-N-nitrosoadrenaline | Epinephrine / Adrenaline | 100 | 2 | 2026-08-14 | ||
| N-Nitroso-esmolol | Esmolol | 1500 | 4 | 2024-01-31 | ||
| N-Nitroso-felodipine | Felodipine | 1500 | 5 | 2023-08-24 | ||
| N-Nitroso-fenfluramine | 19023-40-6 | Fenfluramine | 400 | 3 | 2024-07-29 | |
| N-Nitroso-flecainide | 2901109-58-6 | Flecainide | 1500 | 4 | 2024-04-24 | |
| N-Nitrosofluoxetine | 150494-06-7 | Fluoxetine | 100 | 2023-01-05 | ||
| N-Nitroso-folic acid | 26360-21-4, NFA | Folic acid | NMI | 2023-08-24 | 2026-08-14; 2024-07-29 | |
| N-Nitroso-frovatriptan | Frovatriptan | 400 | 3 | 2025-07-31 | ||
| N-Nitroso-furosemide | 2708280-93-5 | Furosemide | 1500 | 2024-07-29 | ||
| N-Nitroso-desmethyl-galantamine | Galantamine | 18 | 1 | 2025-02-04 | ||
| 2-Nitroso-octahydrocyclopenta(c)pyrrole | 54786-86-6 | Gliclazide | 1700 | 2023-08-24 | ||
| N-Nitroso-hydrochlorothiazide | 63779-86-2, NHCTZ | Hydrochlorothiazide | NMI | 2023-08-24 | ||
| N-Nitroso-hydroxychloroquine EP Impurity C | Hydroxychloroquine | 100 | 2 | 2025-11-03 | ||
| N-Nitroso-hydroxychloroquine EP Impurity D | Hydroxychloroquine | 18 | 1 | 2025-11-03 | ||
| 2-(2-(4-Nitrosopiperazin-1-yl) ethoxy)ethan-1-ol | 73486-81-4 | Hydroxyzine | 1500 | 2026-01-29 | ||
| N-Nitroso-hydroxyzine Impurity A | 1/04/2005 | Hydroxyzine | 400 | 3 | 2025-11-03 | |
| N-Nitroso imatinib | Imatinib | 1500 | 5 | 2024-01-31 | ||
| Indapamide Impurity A | 85440-79-5 | Indapamide | 1500 | 5 | 2024-01-31 | |
| N-Nitroso-ethylenediamine-triacetic acid | 862542-34-5 | Isosorbide mononitrate | 1500 | 4 | 2024-01-31 | |
| N-Nitroso-iminodiacetic acid | 25081-31-6 | Isosorbide mononitrate | 1500 | 4 | 2024-01-31 | |
| N?Nitroso?ivacaftor | Ivacaftor | 1500 | 5 | 2025-02-04 | ||
| N-Nitroso-ketamine | 86144-35-6 | Ketamine | 1500 | 5 | 2023-08-24 | |
| N-Nitroso-labetalol | 2820170-74-7 | Labetalol | 1500 | 2023-08-24 | 2026-08-14 | |
| N-Nitroso-landiolol | Landiolol | 400 | 3 | 2023-08-24 | ||
| N-Nitroso-leniolisib | Leniolisib | 1500 | 5 | 2024-01-31 | ||
| N-Nitroso-desmethyl-lercanidipine | Lercanidipine | 100 | 2 | 2025-04-30 | ||
| N-Nitroso-desmethyl-lercanidipine impurity D | Lercanidipine | 100 | 2 | 2025-04-30 | ||
| N-Nitroso-4-phenylpiperazine | 14340-33-1 | Levodropropizine | 400 | 3 | 2026-01-29 | |
| N-Nitroso-levofloxacin | 1152314-62-9 | Levofloxacin | 1500 | 4 | 2023-08-24 | |
| N-Nitroso-desethyllidocaine | Lidocaine / Lignocaine | 100 | 2 | 2024-01-31 | ||
| N-Nitroso-lisinopril | 519175-80-5, NLP | Lisinopril | NMI | 2023-08-24 | 2024-07-29 | |
| N-Nitroso-desbutyl-lumefantrine | Lumefantrine | 1500 | 2026-01-29 | |||
| N-Nitroso-maprotiline | 204268-61-1 | Maprotiline | 18 | 1 | 2024-10-15 | |
| N-Nitroso-masitinib | Masitinib | 400 | 3 | 2024-04-24 | ||
| N-Nitroso-mefenamic acid | 2114-63-8 | Mefenamic acid | 78000 | 2023-01-05 | ||
| N-Nitroso-meglumine | 62137-31-9 | Meglumine | 100 | 2 | 2026-08-14 | |
| N-Nitroso-iminodibenzyl | 4/08/7458 | Melipramin (Imipramine) | 78000 | 2024-10-15 | ||
| N-Nitroso-meropenem | Meropenem | 1500 | 4 | 2024-04-24 | ||
| N-Nitroso-metamizole impurity E | Metamizole | 1500 | 4 | 2026-08-14 | ||
| N-Nitroso-methylaminoantipyrine | 73829-38-6, NMAA | Metamizole | 100 | 2 | 2025-11-03 | |
| N-Nitroso-dimethylamine | 62-75-9, NDMA | Metformin | 96 | 2019-09-15 | ||
| N-Methyl-N-nitrosoanthranilate | 68061-82-5, NO-MMA | Methyl N-methylanthranilate | 100 | 2 | 2026-01-29 | |
| N-Nitroso-methylphenidate | 55557-03-4, NMPH | Methylphenidate | 1300 | 2022-07-20 | ||
| N-Nitroso-ritalinic acid | Methylphenidate | 1500 | 4 | 2024-04-24 | ||
| N-Nitroso-metoprolol | 138768-62-4 | Metoprolol | 1500 | 4 | 2023-08-24 | |
| N-Nitroso-N-desmethyl-mianserin | Mianserin | 400 | 3 | 2025-04-30 | ||
| N-Nitroso-desmethyl-mifepristone | Mifepristone | 100 | 2 | 2026-01-29 | ||
| N-Nitroso-mirabegron | Mirabegron | 400 | 3 | 2023-08-24 | ||
| N-(2-hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide | MBL-2-NO | Mirabegron | 400 | 3 | 2024-07-29 | |
| N-(4-aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide | MBL-3-NO | Mirabegron | 400 | 3 | 2024-07-29 | |
| N-Nitroso-mirdametinib | Mirdametinib | 78000 | 2025-11-03 | |||
| N-Nitroso-mirtazapine | Mirtazapine | 400 | 3 | 2024-01-31 | ||
| N-Nitroso-morpholine | 59-89-2, NMOR | Molsidomine | 127 | 2025-11-03 | ||
| N-Nitroso-moxifloxacin | Moxifloxacin | 1500 | 4 | 2023-08-24 | ||
| N-Nitroso-nadolol | 134720-06-2 | Nadolol | 1500 | 5 | 2025-11-03 | |
| N-Nitroso-nor-oxycodone | Nalmefene | 1500 | 4 | 2025-02-04 | ||
| N-Nitroso-nebivolol | 1391051-68-5, NNEB | Nebivolol | NMI | 2023-08-24 | 2025-07-31 | |
| N-Nitroso-methylethanolamine | Nefopam | 100 | 2 | 2025-11-03 | ||
| N-Nitroso-anabasine | 37620-20-5, NAB | Nicotine | 1500 | 4 | 2025-02-04 | |
| N-Nitroso-anatabine | 71267-22-6, NAT | Nicotine | 1500 | 4 | 2025-02-04 | |
| N-Nitroso-nornicotine | 16543-55-8, NNN | Nicotine | 100 | 2025-02-04 | ||
| N-Nitroso-nilotinib | 2925306-68-7 | Nilotinib | 1500 | 5 | 2025-02-04 | |
| N-Nitroso desmethyl nintedanib | Nintedanib | 400 | 3 | 2024-01-31 | ||
| N-Nitroso-nirogacestat | Nirogacestat | 1500 | 2025-11-03 | |||
| N-Nitroso-nirogacestat impurity 1 | Nirogacestat | 1500 | 5 | 2025-11-03 | ||
| N-Nitroso-dimethylamine | 62-75-9, NDMA | Nizatidine | 96 | 2019-09-15 | ||
| N-Nitroso-norfloxacin | 74011-53-3 | Norfloxacin | NMI | 2025-07-31 | ||
| N-Nitroso-olanzapine | Olanzapine | 1500 | 5 | 2026-01-29 | ||
| 4-Nitroso-methyl piperazine-1-carboxylate | N-nitroso PMEC | Omecamtiv mecarbil | 400 | 3 | 2024-07-29 | |
| 2-(4-Nitrosopiperazin-1-yl)ethanol | 48121-20-6 | Opipramol | 400 | 3 | 2024-07-29 | |
| N-Nitroso-orphenadrine | NMOA | Orphenadrine | 18 | 1 | 2023-08-24 | |
| N-Nitroso-paroxetine | 2361294-43-9 | Paroxetine | 1500 | 2023-01-05 | 2026-08-14 | |
| N-Nitroso-perindopril | Perindopril | NMI | 2023-08-24 | 2026-01-29 | ||
| N-Nitroso-phenylephrine | 78658-64-7 | Phenylephrine | 100 | 2 | 2023-08-24 | |
| N-Nitroso-posaconazole impurity 1 | Posaconazole | 400 | 3 | 2024-07-29 | ||
| N-Nitroso-pramipexole | Pramipexole | 400 | 3 | 2023-08-24 | ||
| N-Nitroso-propafenone | Propafenone | 100 | 2 | 2024-10-15 | ||
| N-Nitroso-propafenone impurity B | Propafenone | 100 | 2 | 2025-11-03 | ||
| N-Nitroso-propranolol | 84418-35-9 | Propranolol | 1500 | 4 | 2023-08-24 | |
| N-Nitroso-pseudoephedrine | 1850-88-0 | Pseudoephedrine | 1500 | 2023-08-24 | 2026-01-29 | |
| N-Nitroso-aryl piperazine | NDAQ | Quetiapine | 400 | 3 | 2023-08-24 | |
| N-Nitroso quetiapine HEEP impurity / 2-(2-(4-nitrosopiperazin-1-yl)ethoxy)ethan-1-ol | 73486-81-4 | Quetiapine | 1500 | 2024-01-31 | ||
| N-Nitroso-quinapril | 2922985-13-3 | Quinapril | NMI | 2023-08-24 | ||
| N-Nitroso-ramipril | Ramipril | NMI | 2023-08-24 | 2026-01-29 | ||
| N-Nitroso-dimethylamine | 62-75-9, NDMA | Ranitidine | 96 | 2019-09-15 | ||
| Nitroso impurity C” [N-(2,6-dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide] | Ranolazine | 400 | 3 | 2023-08-24 | ||
| N-Nitroso-ranolazine impurity 1 | Ranolazine | 400 | 3 | 2024-01-31 | ||
| N-Nitrosorasagiline | 2470278-90-9 | Rasagaline | 100 | 2 | 2022-07-20 | 2023-08-24 |
| N-Nitroso-reboxetine | Reboxetine | 127 | 2023-08-24 | |||
| N-Nitroso-relebactam | Relebactam | 400 | 3 | 2026-01-29 | ||
| N-Nitroso-N-des(prop-2-enoyl)remibrutinib | LOU064-F8-NO | Remibrutinib | 100 | 2026-08-14 | ||
| N-Nitroso-ribociclib impurity 1 | Ribociclib | 400 | 3 | 2024-01-31 | ||
| 1-Methyl-4-nitrosopiperazine | 16339-07-4, MeNP/MNP | Rifampicin | 400 | 3 | 2022-07-20 | 2023-08-24 |
| N-Nitroso-desmethyl-rifampicin | Rifampicin | 400 | 3 | 2026-08-14 | ||
| N-Nitroso-desformyl-riociguat | Riociguat | 100 | 2 | 2024-07-29 | ||
| N-Nitroso-2,4-thiazole amine | NNTA | Ritonavir | 18 | 1 | 2024-10-15 | |
| Rivaroxaban nitroso impurity 1 | 25413-76-7, N-Nitroso KCR-1 | Rivaroxaban | 1500 | 4 | 2024-07-29 | |
| Rivaroxaban nitroso impurity 2 | Rivaroxaban | 1500 | 4 | 2024-07-29 | ||
| Rivaroxaban nitroso impurity 5 | N-Nitroso RVR-A | Rivaroxaban | 1500 | 4 | 2024-07-29 | |
| N-Nitroso-rivaroxaban amide | Rivaroxaban | 1500 | 4 | 2024-01-31 | ||
| N-Nitroso-rivaroxaban open-ring acid | Rivaroxaban | 1500 | 4 | 2024-01-31 | ||
| N-Nitroso-desmethyl-rivastigmine | Rivastigmine | 100 | 2 | 2024-10-15 | ||
| N-Nitroso-N-desmethyl-rizatriptan | Rizatriptan | 18 | 1 | 2024-10-15 | ||
| N-Nitroso-despropyl-ropinirole | Ropinirole | 18 | 1 | 2025-07-31 | ||
| N-Nitroso-2,6-pipecoloxilidide | 3035512-94-5 | Ropivacaine | 1500 | 4 | 2023-08-24 | |
| N-Nitroso derivative of rotigotine impurity B | Rotigotine | 400 | 3 | 2023-10-16 | ||
| N-Nitroso derivative of rotigotine impurity C | Rotigotine | 1500 | 4 | 2023-10-16 | ||
| N-Nitroso-safinamide | 2657645-00-4 | Safinamide | 400 | 3 | 2025-07-31 | |
| N-Nitroso-salbutamol | 2919946-71-5 | Salbutamol | 1500 | 5 | 2023-08-24 | |
| N-Nitroso-selumetinib | Selumetinib | 78000 | 2026-01-29 | |||
| N-Nitroso-sertraline | Sertraline | 100 | 2 | 2023-08-24 | 2024-10-15; 2023-10-16 | |
| 1-Methyl-4-nitrosopiperazine | 16339-07-4, MeNP/MNP | Sildenafil | 400 | 3 | 2025-11-03 | |
| N-Nitroso-desmethyl-sildenafil | Sildenafil | 400 | 3 | 2024-01-31 | ||
| N-Nitroso-silodosin | Silodosin | 1500 | 4 | 2024-04-24 | ||
| 7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3-a]pyrazine | 2892260-32-9, NTTP | Sitagliptin | 100 | 2 | 2022-07-20 | 2024-07-29 |
| N-Nitroso-sotalol | 134720-07-3 | Sotalol | 1500 | 4 | 2023-08-24 | |
| N-Nitroso-desmethyl-sumatriptan | Sumatriptan | 18 | 1 | 2024-01-31 | ||
| N-Nitroso-desmethyl-tamoxifen | Tamoxifen | 18 | 1 | 2024-04-24 | ||
| N-Nitroso-tamsulosin | 2892260-31-8 | Tamsulosin | 1500 | 4 | 2022-07-20 | 2023-08-24 |
| N-Nitroso-desmethyl-tapentadol | Tapentadol | 18 | 1 | 2026-01-29 | ||
| N-Nitroso terazosin impurity C | Terazosin | 400 | 3 | 2024-04-24 | ||
| N-Nitroso terazosin impurity N | 2470438-57-2 | Terazosin | 400 | 3 | 2024-04-24 | |
| N-Nitroso-desmethyl-terbinafine | NDT/NHNA | Terbinafine | 18 | 1 | 2024-01-31 | |
| N-Nitroso-terbinafine impurity A | 296760-88-8, NTA/NMNA | Terbinafine | 18 | 1 | 2024-01-31 | |
| N-Nitroso-terbinafine degradant | NTD/NHMA | Terbinafine | 18 | 1 | 2024-01-31 | |
| N-Nitroso-tetracaine | Tetracaine | 400 | 3 | 2024-01-31 | ||
| N?Nitroso?ticagrelor | 2476859-55-7 | Ticagrelor | 1500 | 5 | 2024-01-31 | |
| N-Nitroso-tigecycline | Tigecycline | NMI | 2024-07-29 | |||
| N-Nitroso-desmethyl-tramadol | Tramadol | 18 | 1 | 2024-07-29 | ||
| N-Nitroso-trandolapril | Trandolapril | 1500 | 5 | 2024-07-29 | ||
| N-Nitroso-trientine impurity 1 | 2817316-41-7 | Trientine | 18 | 1 | 2024-07-29 | |
| N-Nitroso-desmethyl trimebutine | Trimebutine | 1500 | 5 | 2023-08-24 | ||
| N-Nitroso-trimetazidine | 92432-50-3, NTMZ | Trimetazidine | 15000 | 2023-08-24 | 2026-08-14 | |
| N-Nitroso-desmethyl-tripelennamine | Tripelennamine | 18 | 1 | 2023-08-24 | ||
| 2-(N-Nitrosomethylamino)-N-[6-(trifluoromethoxy)-1,3-benzothiazol-2-yl]acetamide | NNT | Troriluzole | 100 | 2 | 2025-04-30 | |
| N-Nitroso-sarcosine | 13256-22-9, NSAR | Troriluzole | 1500 | 4 | 2025-04-30 | |
| N-Nitroso-desmethyl-ulipristal acetate | NDUPA | Ulipristal acetate | 100 | 2 | 2026-08-14 | |
| N-Nitroso-urapidil | Urapidil | 1500 | 4 | 2024-01-31 | ||
| N-Nitroso-N-methyl-valaciclovir | Valaciclovir | 1500 | 2024-04-24 | |||
| N-Nitroso-N-ethyl-valaciclovir | Valaciclovir | 400 | 3 | 2023-08-24 | ||
| N-Nitroso-valsartan cyano-desvalerylmethylester | Valsartan | 100 | 2 | 2024-10-15 | ||
| N-Nitroso-desvaleryl-valsartan | 2254485-68-0 | Valsartan | NMI | 2024-07-29 | ||
| N-Nitroso-vancomycin | 155386-25-7 | Vancomycin | NMI | 2025-04-30 | 2026-08-14 | |
| N-Nitroso-vanzacaftor | Vanzacraftor | 1500 | 4 | 2024-10-15 | ||
| N-Nitroso-varenicline | 2755871-02-2, NNV | Varenicline | 400 | 3 | 2022-07-20 | 2023-10-16 |
| N-Nitroso-venlafaxine EP Impurity D | 2680662-11-5 | Venlafaxine | 18 | 1 | 2025-11-03 | |
| N-Nitroso-venlafaxine EP Impurity H | Venlafaxine | 100 | 2 | 2025-11-03 | ||
| N-Nitroso-vibegron | Vibegron | 1500 | 5 | 2024-07-29 | ||
| N-Nitroso vildagliptin amide impurity | Vildagliptin | 1500 | 5 | 2024-10-15 | ||
| N-Nitroso-vildagliptin | Vildagliptin | 1500 | 5 | 2023-08-24 | ||
| N-Nitroso-L-prolinamide | 79108-51-3 | Vildagliptin | 1500 | 4 | 2025-02-04 | |
| N-Nitroso-L-prolinenitrile | Vildagliptin | 1500 | 4 | 2025-02-04 | ||
| N-Nitroso-vortioxetine | Vortioxetine | 400 | 3 | 2023-08-24 | ||
| N?Nitroso?desmethyl?zolmitriptan | Zolmitriptan | 18 | 1 | 2025-02-04 | ||
| N-Nitroso-diethylamine | 55-18-5, NDEA | 26.5 | 2019-09-15 | |||
| N-Nitroso-dimethylamine | 62-75-9, NDMA | 96 | 2019-09-15 | |||
| N-Nitroso-diisopropylamine | 601-77-4, DIPNA/NDIPA | 1500 | 5 | 2019-09-15 | 2024-07-29 | |
| N-Nitroso-ethylisopropylamine | 16339-04-1, EIPNA/NEIPA | 400 | 3 | 2019-09-15 | 2024-07-29 | |
| N-Nitroso-N-methyl-4-aminobutyric acid | 61445-55-4, NMBA | 1500 | 4 | 2019-09-15 | 2024-07-29 | |
| N-Nitroso-1,2,3,6-tetrahydropyridine | 55556-92-8, NTHP | 37 | 2022-07-20 | |||
| N-Nitroso-di-n-butylamine | 924-16-3, NDBA | 26.5 | 2022-07-20 | |||
| N-Nitroso-dipropylamine | 621-64-7, NDPA | 26.5 | 2022-07-20 | |||
| N-Nitroso-morpholine | 59-89-2, NMOR | 127 | 2022-07-20 | |||
| N-Nitrosopiperidine | 100-75-4 | 1300 | 2022-07-20 | |||
| N-Nitrosodiisopropanolamine | 53609-64-6, NDIPLA | 1500 | 4 | 2024-04-24 | ||
| N-Nitroso-piperazine | 5632-47-3, NPZ | 400 | 3 | 2023-08-24 | ||
| 1-Nitroso-pyrrolopiperidine | 1500 | 4 | 2023-08-24 | |||
| N-Nitroso-N-ethyl-benzylamine | 20689-96-7, NBEA | 18 | 1 | 2024-07-29 | ||
| N-Nitroso-N-methylaniline | 614-00-6, NMPA | 100 | 2 | 2024-01-31 | ||
| 4-(Methylnitrosoamino)-1-(3-pyridinyl)-1-butanone | 64091-91-4, NNK | 100 | 2023-01-05 | |||
| N-Methyl-N-nitrosophenethylamine | 13256-11-6, NMPEA | 8 | 2023-01-05 | |||
| N-Nitroso-diethanolamine | 1116-54-7, NDELA | 1900 | 2023-01-05 | |||
| N-Nitroso-diphenylamine | 86-30-6, NDPh | 78000 | 2023-01-05 | |||
| N-Nitroso-pyrrolidine | 930-55-2, NPYR | 1700 | 2023-01-05 | |||
| N,N'-Dimethylethylenedinitrosamine | 13256-12-7, NDMEA / NNDMA | 18 | 1 | 2026-08-14 |
CPCA: Carcinogenic Potency Categorisation Approach.
NMI: Non mutagenic impurity should be controlled to ICH Q3A and ICH Q3B guideline limits.
* Potential presence of nitrosamine impurities with structures derived from drug substances or their related impurities. This does not mean that the impurity will be found in all products or pharmaceutical forms containing the drug substance. Please refer to EMA's Q&A on the risk factors for the presence of nitrosamines for details.
** Acceptable Intake (AI) Limit to be applied to maximum daily dose (MDD) of the drug product. These limits are applicable only if a product contains a single N-nitrosamine.
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