Nitrosamine impurities in medications: Established acceptable intake limits
Established Acceptable Intake Limits (Excel version - (926.6 Kb))
Health Canada's table of established Acceptable Intake limits (Appendix 1) has been removed from the guidance document and placed in this tab.
- CAS RN
- Chemical Abstracts Service Registry Number
- CPCA
- Carcinogenic Potency Categorization Approach
- AI
- Acceptable Intake
- -
- Not applicable
Related Drug Substance | N-nitrosamine (and acronym, if available) |
Chemical Structure | CAS RN | CPCA Category | AI Limit (ng/day)Table 1 footnote * | Date Most Recently Published (YYYY-MM-DD) |
---|---|---|---|---|---|---|
- | N-nitroso-N-ethyl-benzylamine (NBEA) | 20689-96-7 | 1 | 18 | 2024-05-31 | |
Trientine | N-(2-aminoethyl)-N-(2-((2-aminoethyl)amino)ethyl)nitrous amide | - | 1 | 18 | 2024-05-31 | |
- | 3-((ethyl(nitroso)amino)methyl)benzenesulfonate | - | 1 | 18 | 2024-05-31 | |
Edoxaban | N-nitroso-N-desmethyl-edoxaban | - | 2 | 100 | 2024-05-31 | |
Mirabegron | (R)-N-(2-hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide | - | 3 | 400 | 2024-05-31 | |
Mirabegron | (R)-N-(4-aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide | - | 3 | 400 | 2024-05-31 | |
Posaconazole | 1-(4-(((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)-4-nitrosopiperazine | - | 3 | 400 | 2024-05-31 | |
Argatroban | N-nitroso-argatroban | - | 4 | 1500 | 2024-05-31 | |
Articaine | N-nitroso-articaine | - | 4 | 1500 | 2024-05-31 | |
Rivaroxaban | (S)-2-(2-((4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)(nitroso)amino)ethoxy)acetic acid | - | 4 | 1500 | 2024-05-31 | |
Rivaroxaban | (S)-N-(3-(1,3-dioxoisoindolin-2-yl)-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide | - | 4 | 1500 | 2024-05-31 | |
Rivaroxaban | N-(2-hydroxyethyl)-N-phenylnitrous amide | 25413-76-7 | 4 | 1500 | 2024-05-31 | |
Rivaroxaban | (R)-N-(3-chloro-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide | - | 4 | 1500 | 2024-05-31 | |
Clozapine | N-nitroso-clozapine EP Impurity C | - | 3 | 400 | 2024-03-28 | |
- | N-nitroso-meglumine | 62137-31-9 | - | 1500Table 1 footnote *** | 2024-03-28 | |
Silodosin | N-nitroso-silodosin | - | 4 | 1500 | 2024-03-28 | |
Methylphenidate | N-nitroso-ritalinic acid | - | 4 | 1500 | 2024-03-28 | |
Apixaban | N-nitroso-apixaban EP Impurity B | - | 4 | 1500 | 2024-03-28 | |
Terazosin | N-nitroso-terazosin EP Impurity C | - | 3 | 400 | 2024-03-28 | |
Gliclazide | 2-nitrosooctahydrocyclo-penta[c]pyrrole (Gliclazide EP Impurity B) | 54786-86-6 | - | 1700 | 2024-03-28 | |
Indapamide | (2RS)-2-methyl-1-nitroso-2,3-dihydro-1H-indole (Indapamide EP Impurity A) | 85440-79-5 | 5 | 1500 | 2024-03-28 | |
- | N-nitroso-piperazine | 5632-47-3 | 3 | 400 | 2023-07-24 | |
- | N-nitroso-pyrrolidine (NPYR) | 930-55-2 | - | 1700 | 2023-07-24 | |
- | N-nitroso-diethanolamine (NDELA) | 1116-54-7 | - | 1900 | 2023-04-17 | |
- | N-nitroso-diphenylamine (NDPh) | 86-30-6 | - | 78000 | 2023-04-17 | |
- | 4-(methylnitrosamino)-1-(3-pyridyl)-1-(butanone) (NNK) | 64091-91-4 | - | 100 | 2022-09-01 | |
- | N-methyl-N-nitroso-phenethylamine (NMPEA) | 13256-11-6 | - | 8 | 2022-05-27 | |
- | N-nitroso-1,2,3,6-tetrahydropyridine (NTHP) | 55556-92-8 | - | 37 | 2022-05-27 | |
- | N-nitroso-piperidine (NPIP) | 100-75-4 | - | 1300 | 2022-05-27 | |
- | N-nitroso-dipropylamine (NDPA) | 621-64-7 | - | 26.5 | 2021-12-06 | |
- | N-nitroso-morpholine (NMOR) | 59-89-2 | - | 127 | 2021-12-06 | |
- | N-nitroso-dibutylamine (NDBA) | 924-16-3 | - | 26.5 | 2020-12-15 | |
- | N-nitroso-4-(methylamino)butyric acid (NMBA) | 61445-55-4 | 4 | 1500 | 2024-05-31 | |
- | N-nitroso-diethylamine (NDEA) | 55-18-5 | - | 26.5 | 2019-10-02 | |
- | N-nitroso-diisopropylamine (NDIPA) | 601-77-4 | 5 | 1500 | 2024-05-31 | |
- | N-nitroso-dimethylamine (NDMA) | 62-75-9 | - | 96 | 2019-10-02 | |
- | N-nitroso-ethylisopropylamine (NEIPA) | 16339-04-1 | 3 | 400 | 2024-05-31 | |
- | 1-methyl-4-nitrosopiperazine (MNP) | 16339-07-4 | 3 | 400 | 2023-07-24 | |
Alogliptin | 3-amino-N-nitrosopiperidine | 2819242-71-0 | 3 | 400 | 2023-10-20 | |
Amitriptyline | N-nitroso-nortriptyline (NNORT) | 55855-42-0 | - | 8 | 2022-05-27 | |
Aripiprazole | 1-(2,3-dichlorophenyl)-4-nitrosopiperazine | 2221987-86-4 | 3 | 400 | 2024-03-15 | |
Atenolol | N-nitroso-atenolol | 134720-04-0 | 4 | 1500 | 2023-07-24 | |
Atomoxetine | N-nitroso-atomoxetine | - | - | 100 | 2023-07-24 | |
Azelastine | N-nitroso-desmethylazelastine | - | 2 | 100 | 2024-03-15 | |
Azithromycin | N-nitroso-azaerythromycin | - | - | -Table 1 footnote ** | 2023-07-24 | |
Azithromycin | N-nitroso-N- desmethylazithromycin | - | - | -Table 1 footnote ** | 2023-07-24 | |
Benazepril | N-nitroso-benazepril | - | 5 | 1500 | 2023-07-24 | |
Benzydamine | 2-[benzyl(nitroso)amino] benzoic acid | 1028-91-7 | 4 | 1500 | 2024-03-15 | |
Betahistine | N-nitroso-betahistine | 32635-81-7 | 1 | 18 | 2023-07-24 | |
Betaxolol | N-nitroso-betaxolol | - | 4 | 1500 | 2024-03-15 | |
Bilastine | 1-(2-ethoxyethyl)-2-(1-nitrosopiperidin-4-yl)-1H-benzo[d]imidazole | - | 3 | 400 | 2024-03-15 | |
Bisoprolol | N-nitroso-bisoprolol | 2820170-76-9 | 4 | 1500 | 2023-07-24 | |
Bumetanide | N-nitroso-bumetanide | 2490432-02-3 | 4 | 1500 | 2024-03-15 | |
Bupropion | N-nitroso-bupropion | 2763780-10-3 | 5 | 1500 | 2023-07-24 | |
Cilazapril | N-nitroso-cilazapril | 1053740-92-3 | 5 | 1500 | 2023-07-24 | |
Cinacalcet | N-nitroso-cinacalcet | - | 3 | 400 | 2023-10-20 | |
Ciprofloxacin | N,N'-dinitrosopiperazine | 140-79-4 | 3 | 400 | 2023-07-24 | |
Ciprofloxacin | N-nitroso-ciprofloxacin | 864443-44-7 | 4 | 1500 | 2023-07-24 | |
Citalopram | N-nitroso-desmethyl-citalopram | - | 1 | 18 | 2023-07-24 | |
Clarithromycin | N-nitroso-N-desmethyl-clarithromycin | - | - | Footnote ** | 2024-05-31 | |
Clozapine | N-nitroso-clozapine | 156632-03-0 | 5 | 1500 | 2023-07-24 | |
Dabigatran etexilate | N-nitroso-dabigatran etexilate | - | - | 1500Table 1 footnote *** | 2024-03-15 | |
Daridorexant | 5-chloro-4-methyl-2- [(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]- 1H-benzimidazole | - | 5 | 1500 | 2024-03-15 | |
Desloratadine | N-nitroso-desloratadine | 1246819-22-6 | 3 | 400 | 2023-07-24 | |
Desvenlafaxine | N-nitroso-N-desmethyl-desvenlafaxine | - | 1 | 18 | 2023-07-24 | |
Dextromethorphan | N-nitroso-N-desmethyl-dextromethorphan | - | 4 | 1500 | 2023-07-24 | |
Diclofenac | N-nitroso-diclofenac | 66505-80-4 | 5 | 1500 | 2023-07-24 | |
Diphenhydramine | N-nitroso-N-desmethyl-diphenhydramine | 55855-43-1 | 1 | 18 | 2023-07-24 | |
Dorzolamide | N-nitroso-dorzolamide | - | - | 1500Table 1 footnote *** | 2024-03-15 | |
Doxepin | N-nitroso-nordoxepin | - | 1 | 18 | 2023-07-24 | |
Doxycycline | N-nitroso-N-desmethyl-doxycycline | - | 3 | 400 | 2023-07-24 | |
Doxylamine | N-nitroso-N-desmethyl-doxylamine | - | 1 | 18 | 2023-07-24 | |
Doxylamine | N-nitroso-N-methyl-2- [1-phenyl-1-(2-pyridinyl) methoxy]ethanamine | - | 1 | 18 | 2023-07-24 | |
Duloxetine | N-nitroso-duloxetine (NDLX) | - | - | 100 | 2022-05-27 | |
Enalapril | N-nitroso-enalapril | - | 5 | 1500 | 2023-07-24 | |
Felodipine | N-nitroso-felodipine | - | 5 | 1500 | 2023-07-24 | |
Flecainide | N-nitroso-flecainide | - | 4 | 1500 | 2023-07-24 | |
Fluoxetine | N-nitroso-fluoxetine | 150494-06-7 | - | 100 | 2023-07-24 | |
Folic acid | N-nitroso-folic acid | 26360-21-4 | 4 | 1500 | 2023-07-24 | |
Frovatriptan | N-nitroso-frovatriptan | - | 3 | 400 | 2023-07-24 | |
Furosemide | N-nitroso-furosemide | 2708280-93-5 | 4 | 1500 | 2023-07-24 | |
Hydrochlorothiazide | N-nitroso-hydrochlorothiazide | 63779-86-2 | - | -Table 1 footnote ** | 2023-07-24 | |
Hydroxyzine | 2-(2-(4-nitrosopiperazin-1-yl) ethoxy)ethan-1-ol | 73486-81-4 | 3 | 400 | 2023-07-24 | |
Ketamine | N-nitroso-ketamine | 86144-35-6 | 5 | 1500 | 2023-07-24 | |
Labetalol | N-nitroso-labetalol | 2820170-74-7 | 4 | 1500 | 2023-07-24 | |
Landiolol | N-nitroso-landiolol | - | 3 | 400 | 2024-03-15 | |
Leucovorin | N-nitroso-folinic acid | 66505-80-4 | - | -Table 1 footnote ** | 2024-03-15 | |
Levofloxacin | (S)-10-((2-aminoethyl) (nitroso)amino)-9-fluoro- 3-methyl-7-oxo-2,3-dihydro- 7H-[1,4]oxazino[2,3,4-ij] quinoline-6-carboxylic acid | - | 4 | 1500 | 2023-07-24 | |
Levofloxacin | N-nitroso-N-desmethyl-levofloxacin | 1152314-62-9 | 4 | 1500 | 2023-07-24 | |
Lidocaine | N-nitroso-desethyl-lidocaine | - | 2 | 100 | 2023-07-24 | |
Lisinopril | N-nitroso-lisinopril | 519175-80-5 | - | Footnote ** | 2024-05-31 | |
Mefenamic acid | N-nitroso-mefenamic acid | 2114-63-8 | - | 78000 | 2023-04-17 | |
Meropenem | N-nitroso-meropenem | - | 4 | 1500 | 2023-07-24 | |
Methylphenidate | N-nitroso-methylphenidate (NMPH) | 55557-03-4 | - | 1300 | 2022-05-27 | |
Metoprolol | N-nitroso-metoprolol | 134720-05-1 | 4 | 1500 | 2023-07-24 | |
Mirabegron | N-nitroso-mirabegron | - | 3 | 400 | 2023-07-24 | |
Mirtazapine | N-nitroso-N-desmethyl- mirtazepine | - | 3 | 400 | 2024-03-15 | |
Moxifloxacin | N-nitroso-moxifloxacin | - | 4 | 1500 | 2023-07-24 | |
Nebivolol | N-nitroso-nebivolol | 1391051-68-5 | 4 | 1500 | 2023-07-24 | |
Nortriptyline | N-nitroso-nortriptyline (NNORT) | 55855-42-0 | - | 8 | 2022-05-27 | |
Orphenadrine | N-nitroso-N-desmethyl- orphenadrine (NMOA) | - | 1 | 18 | 2023-07-24 | |
Paroxetine | N-nitroso-paroxetine | 2361294-43-9 | - | 1300 | 2023-04-17 | |
Penicillin G benzathine | N,N'-dinitroso-N,N'- dibenzylethanediamine | - | 1 | 18 | 2023-07-24 | |
Penicillin G benzathine | N-nitroso-N,N'- dibenzylethanediamine | - | 1 | 18 | 2023-07-24 | |
Perindopril | N-nitroso-perindopril | - | 5 | 1500 | 2023-07-24 | |
Phenylephrine | N-nitroso-phenylephrine | 78658-64-7 | 2 | 100 | 2023-07-24 | |
Pramipexole | N-nitroso-pramipexole | - | 3 | 400 | 2023-07-24 | |
Propranolol | N-nitroso-propranolol | 84418-35-9 | 4 | 1500 | 2023-07-24 | |
Pseudoephedrine | N-nitroso-pseudoephedrine | 1850-88-0 | 4 | 1500 | 2023-07-24 | |
Quetiapine | N-nitroso-desalkyl- quetiapine (NDAQ) | - | 3 | 400 | 2023-07-24 | |
Quinapril | N-nitroso-quinapril | 158522-79-3 | - | -Table 1 footnote ** | 2023-07-24 | |
Ramipril | N-nitroso-ramipril | - | 5 | 1500 | 2023-07-24 | |
Ranolazine | 1-(2-methoxyphenoxy)- 3-(4-nitrosopiperazin-1-yl) propan-2-ol | - | 3 | 400 | 2024-03-15 | |
Ranolazine | N-(2,6-dimethylphenyl)- 2-(4-nitrosopiperazin-1-yl) acetamide | - | 3 | 400 | 2024-03-15 | |
Rasagiline | N-nitroso-rasagiline | 2470278-90-9 | 2 | 100 | 2023-07-24 | |
Ribociclib | N-nitroso-ribociclib | - | 3 | 400 | 2024-03-15 | |
Rifapentine | 1-cyclopentyl-4- nitrosopiperazine (CPNP) | 61379-66-6 | 3 | 400 | 2023-07-24 | |
Rivaroxaban | (S)-5-chloro-N-(2-hydroxy-3-(nitroso(4-(3-oxomorpholino)phenyl)amino)propyl)thiophene-2-carboxamide | - | 4 | 1500 | 2023-10-20 | |
Rivastigmine | N-nitroso-N-desmethyl- rivastigmine | - | 2 | 100 | 2023-07-24 | |
Salbutamol | N-nitroso-salbutamol | - | 5 | 1500 | 2023-07-24 | |
Sertraline | N-nitroso-sertraline | - | - | 1500Table 1 footnote *** | 2023-10-20 | |
Sildenafil | N-nitroso-N-desmethyl- sildenafil | - | 3 | 400 | 2024-03-15 | |
Sitagliptin | 7-nitroso-3-(trifluoromethyl)- 5,6,7,8-tetrahydro[1,2,4] triazolo-[4,3-a]pyrazine (NTTP) | 2892260-32-9 | 2 | 100 | 2024-05-31 | |
Sotalol | N-nitroso-sotalol | 134720-07-3 | 4 | 1500 | 2023-07-24 | |
Sumatriptan | N-nitroso-N-desmethyl- sumatriptan | - | 1 | 18 | 2023-07-24 | |
Tamsulosin | N-nitroso-tamsulosin | 2892260-31-8 | 4 | 1500 | 2023-07-24 | |
Terazosin | (4-nitrosopiperazin-1-yl) (tetrahydrofuran-2-yl)methanone | - | 3 | 400 | 2024-03-15 | |
Terbinafine | N-[(2E)-6,6-dimethyl- 2-hepten-4-yn-1-yl]- N-nitrosomethanamine | - | 1 | 18 | 2023-07-24 | |
Terbinafine | N-nitroso-N-desmethyl- terbinafine | - | 1 | 18 | 2023-07-24 | |
Terbinafine | N-nitroso-N-methyl-1- naphthylmethylamine | 269760-88-8 | 1 | 18 | 2023-07-24 | |
Tigecycline | N-nitroso-tigecycline | - | - | Footnote ** | 2024-05-31 | |
Tofacitinib | N-methyl-N-((3R,4R)- 4-methyl-1-nitrosopiperidin-3-yl) -7H-pyrrolo[2,3-d]pyrimidin-4-amine | - | 3 | 400 | 2024-03-15 | |
Trimebutine | N-nitroso-N-desmethyl- trimebutine | - | 5 | 1500 | 2023-07-24 | |
Tripelennamine | N-nitroso-N-desmethyl- tripelennamine | - | 1 | 18 | 2023-07-24 | |
Valacyclovir | N-nitroso-N-ethyl-valacyclovir | - | 3 | 400 | 2023-07-24 | |
Valacyclovir | N-nitroso-N-methyl-valacyclovir | - | 3 | 400 | 2023-07-24 | |
Valsartan | (S)-2-(((2'-(1H-tetrazol-5-yl)- [1,1′-biphenyl]-4-yl) methyl)(nitroso)amino)- 3-methylbutanoic acid | 2254485-68-0 | - | -Table 1 footnote ** | 2023-07-24 | |
Varenicline | N-nitroso-varenicline (NNV) | 2755871-02-2 | 3 | 400 | 2023-07-24 | |
Vortioxetine | N-nitroso-vortioxetine | - | 3 | 400 | 2023-07-24 | |
Table 1 Notes
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