The revision table below includes updates to nitrosamine and other nitroso-structure acceptable intake (AI) limit information published by the TGA.
- Acceptable intakes (AIs) for nitrosamine impurities in medicines are published at Established acceptable intake for nitrosamines in medicines.
- AIs for other nitroso-structure impurities in medicines are published at Established acceptable intake for other nitroso-structures in medicines.
Further updates related to nitrosamines in medicines include minor editorial amendments, changes to Information for sponsors and manufacturers regarding nitrosamine impurities in medicines and safety alerts for medicines affected by recalls and medicine shortages due to the presence of unacceptable levels of nitrosamines.
Safety advisories are published on our Safety alerts page. The safety alerts due to nitrosamines include:
- 'sartan' blood pressure medicines in 2018
- metformin products and ranitidine products in 2019
- varenicline products in 2021
- rifampicin products in 2021
- sitagliptin products and quinapril products in 2022
- fluoxetine products and duloxetine products in 2023
Recall actions are available by searching our Recall actions database . Medicine shortages are published on our Medicine shortage reports database.
Revision to nitrosamine and nitroso-compound information published by the TGA
Date published | Nitrosamine or other N-Nitroso-structure name | Update |
|---|---|---|
15 September 2019 | N-Nitroso-diethylamine (NDEA) | Include AI limit of 26.5 ng/day |
15 September 2019 | N-Nitroso-diisopropylamine / N,N-di(propan-2-yl)nitrous amide (DIPNA/NDIPA) | Include AI limit of 26.5 ng/day |
15 September 2019 | N-Nitroso-dimethylamine (NDMA) | Include AI limit of 96.0 ng/day |
15 September 2019 | N-Nitroso-ethylisopropylamine / N-ethyl-N-propan-2-ylnitrous amide (EIPNA/NEIPA) | Include AI limit of 26.5 ng/day |
15 September 2019 | N-Nitroso-N-methyl-4-aminobutyric acid / 4-[methyl(nitroso)amino]butanoic acid (NMBA) | Include AI limit of 96.0 ng/day |
20 July 2022 | 1-Methyl-4-nitrosopiperazine (MeNP/MNP) | Include AI limit of 26.5 ng/day |
20 July 2022 | 7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3-a]pyrazine (NTTP) | Include AI limit of 37.0 ng/day |
20 July 2022 | N-Nitroso-1,2,3,6-tetrahydropyridine (NTHP) | Include AI limit of 37.0 ng/day |
20 July 2022 | N-Nitroso-di-n-butylamine (NDBA) | Include AI limit of 26.5 ng/day |
20 July 2022 | N-Nitroso-dipropylamine (NDPA) | Include AI limit of 26.5 ng/day |
20 July 2022 | N-Nitroso-duloxetine (NDLX) | Include AI limit of 100.0 ng/day |
20 July 2022 | N-Nitroso-methylphenidate | Include AI limit of 1300 ng/day |
20 July 2022 | N-Nitroso-morpholine (NMOR) | Include AI limit of 127.0 ng/day |
20 July 2022 | N-Nitroso-nortriptyline (NNORT) | Include AI limit of 8.0 ng/day |
20 July 2022 | N-Nitroso-tamsulosin | Include AI limit of 18.0 ng/day |
20 July 2022 | N-Nitroso-varenicline | Include AI limit of 37.0 ng/day |
20 July 2022 | N-Nitrosopiperidine | Include AI limit of 1300 ng/day |
20 July 2022 | N-Nitrosorasagiline | Include AI limit of 18.0 ng/day |
5 January 2023 | 4-(Methylnitrosoamino)-1-(3-pyridinyl)-1-butanone (NNK) | Include AI limit of 100 ng/day |
5 January 2023 | N-Methyl-N-nitrosophenethylamine (NMPEA) | Include AI limit of 8.0 ng/day |
5 January 2023 | N-Nitroso-dabigatran etexilate (NDAB) | Include AI limit of 18.0 ng/day |
5 January 2023 | N-Nitroso-diethanolamine (NDELA) | Include AI limit of 1900 ng/day |
5 January 2023 | N-Nitroso-diphenylamine (NDPh) | Include AI limit of 78000 ng/day |
5 January 2023 | N-Nitroso-mefenamic acid | Include AI limit of 78000 ng/day |
5 January 2023 | N-Nitroso-paroxetine | Include AI limit of 1300 ng/day |
5 January 2023 | N-Nitroso-pyrrolidine (NPYR) | Include AI limit of 1700 ng/day |
5 January 2023 | N-Nitrosofluoxetine | Include AI limit of 100 ng/day |
24 August 2023 | 1-Methyl-4-nitrosopiperazine (MeNP/MNP) | Increase AI limit from 26.5 ng/day to 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-tamsulosin | Increase AI limit from 18.0 ng/day to 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitrosorasagiline | Increase AI limit from 18.0 ng/day to 100 ng/day based on CPCA potency category 2 |
24 August 2023 | 1-Nitroso-pyrrolopiperidine | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | 2-Nitroso-octahydrocyclopenta(c)pyrrole | Include AI limit of 1700 ng/day |
16 October 2023 | 3-Amino-N-nitrosopiperidine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-ambroxol | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-dabigatran etexilate (NDAB) | Increase AI limit from 18.0 ng/day to 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-2,6-pipecoloxilidide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-aryl piperazine / N-nitroso-desalkylquetiapine (NDAQ) | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-atenolol | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-atomoxetine | Include AI limit of 100 ng/day |
24 August 2023 | N-Nitroso-azithromycin | Include as non-mutagenic impurity (NMI) |
24 August 2023 | N-Nitroso-benazepril | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-betahistine | Include AI limit of 18 ng/day based on CPCA potency category 1 |
24 August 2023 | N-Nitroso-bisoprolol (NBP) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-bumetanide (NNB) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-bupropion | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-cilazapril | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-ciprofloxacin | Include AI limit of 1500 ng/day |
24 August 2023 | N-Nitroso-desloratadine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-desmethyl trimebutine | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-desmethyl-chloropyramine (N-DMCP) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
24 August 2023 | N-Nitroso-desmethyl-tripelennamine | Include AI limit of 18 ng/day based on CPCA potency category 1 |
24 August 2023 | N-Nitroso-desmethylazithromycin | Include as non-mutagenic impurity (NMI) |
24 August 2023 | N-Nitroso-diclofenac | Include AI limit of 1500 ng/day |
24 August 2023 | N-Nitroso-enalapril | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-felodipine | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-folic acid / 2-[[4-[(2-amino-4-oxo-3H-pteridin-6-yl)methyl-nitrosoamino] benzoyl]amino]pentanedioic acid (NFA) | Include AI limit of 1500 ng/day |
24 August 2023 | N-Nitroso-hydrochlorothiazide (NHCTZ) | Include as non-mutagenic impurity (NMI) |
24 August 2023 | N-Nitroso-ketamine | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-labetalol | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-landiolol | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-levofloxacin | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-lisinopril / N2-((S)-1-carboxy-3-phenylpropyl)-N2-nitroso-L-lysyl-L-proline (NLP) | Include AI limit of 1500 ng/day |
24 August 2023 | N-Nitroso-metoprolol | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-mirabegron | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-moxifloxacin | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-N-ethyl-valaciclovir | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-nebivolol (NNEB) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-orphenadrine (NMOA) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
24 August 2023 | N-Nitroso-p-chloro-benzylamino-pyridine (N-CBAP) | Include AI limit of 100 ng/day based on CPCA potency category 2 |
24 August 2023 | N-Nitroso-perindopril | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-phenylephrine | Include AI limit of 100 ng/day based on CPCA potency category 2 |
24 August 2023 | N-Nitroso-piperazine (NPZ) | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-pramipexole | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-praziquanamine / [2-nitroso-2,3,6,7-tetrahydro-1H-pyrazino[2,1-a]isoquinolin-4(11bH)-one] | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-propranolol | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-pseudoephedrine | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-quinapril | Include as non-mutagenic impurity (NMI) |
24 August 2023 | N-Nitroso-ramipril | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-reboxetine | Include AI limit of 127 ng/day |
24 August 2023 | N-Nitroso-salbutamol | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-sertraline | Include AI limit of 100 ng/day |
24 August 2023 | N-Nitroso-sotalol | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 August 2023 | N-Nitroso-trimetazidine (NTMZ) | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | N-Nitroso-vildagliptin | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 August 2023 | N-Nitroso-vortioxetine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 August 2023 | Nitroso impurity C” [N-(2,6-dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide] | Include AI limit of 400 ng/day based on CPCA potency category 3 |
16 October 2023 | 3-Amino-N-nitrosopiperidine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
16 October 2023 | N-Nitroso derivative of rotigotine impurity B / N-(5-hydroxy-1,2,3,4-tetrahydronaphthalen-2-yl)-N-propylnitrous amide | Include AI limit of 400 ng/day based on CPCA potency category 3 |
16 October 2023 | N-Nitroso derivative of rotigotine impurity C / N-(5-hydroxy-1,2,3,4-tetrahydronaphthalen-2-yl)-N-(-2-(thiophen-2-yl)ethyl)nitrous amide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
16 October 2023 | N-Nitroso-varenicline | Increase AI limit from 37.0 ng/day to 400 ng/day based on CPCA potency category 3 |
16 October 2023 | N-Nitroso-sertraline | Increase AI limit from 100 ng/day to 1500 ng/day |
31 January 2024 | N-Nitroso-ambroxol | Increase AI limit from 400 ng/day to 1500 ng/day |
31 January 2024 | 1-(2,3-Dichlorophenyl)-4-nitrosopiperazine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | 5-Chloro-4-methyl-2-[(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]-1H-benzimidazole (IDOR-1135-8758) | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
31 January 2024 | Indapamide impurity A / 2-methyl-1-nitroso-2,3-dihydroindole | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
31 January 2024 | N-Nitroso desmethyl nintedanib | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | N-Nitroso imatinib | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
31 January 2024 | N-Nitroso quetiapine HEEP impurity / 2-(2-(4-nitrosopiperazin-1-yl)ethoxy)ethan-1-ol | Include AI limit of 1500 ng/day |
31 January 2024 | N-nitroso ranolazine impurity 1 / 1-(2-methoxyphenoxy)-3-(4-nitrosopiperazin-1-yl)propan-2-ol | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | N-Nitroso-azacyclonol | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | N-Nitroso-betaxolol | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
31 January 2024 | N-Nitroso-calcium folinate | Include as non-mutagenic impurity (NMI) |
31 January 2024 | N-Nitroso-celiprolol | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
31 January 2024 | N-Nitroso-cinacalcet | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | N-Nitroso-desethyllidocaine | Include AI limit of 100 ng/day based on CPCA potency category 2 |
31 January 2024 | N-Nitroso-desmethyl sumatriptan | Include AI limit of 18 ng/day based on CPCA potency category 1 |
31 January 2024 | N-Nitroso-desmethyl-azelastine | Include AI limit of 100 ng/day based on CPCA potency category 2 |
31 January 2024 | N-Nitroso-desmethyl-citalopram / N-(3-(5-cyano-1-(4-fluorophenyl)-1, 3-dihydroisobenzofuran-1-yl)propyl)-N-methylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
31 January 2024 | N-Nitroso-desmethyl-sildenafil | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | N-Nitroso-desvenlafaxine | Include AI limit of 18 ng/day based on CPCA potency category 1 |
31 January 2024 | N-Nitroso-dorzolamide | Include AI limit of 1500 ng/day |
31 January 2024 | N-Nitroso-esmolol | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
31 January 2024 | N-Nitroso-ethylenediamine-triacetic acid | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
31 January 2024 | N-Nitroso-iminodiacetic acid | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
31 January 2024 | N-Nitroso-leniolisib | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
31 January 2024 | N-Nitroso-mirtazapine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | N-Nitroso-N-methylaniline / N-methyl-N-phenylnitrous amide (NMPA) | Include AI limit of 100 ng/day based on CPCA potency category 2 |
31 January 2024 | N-Nitroso-ribociclib impurity 1 / 7-cyclopentyl-N,N-dimethyl-2-((5-(4-nitrosopiperazin-1-yl)pyridine-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | N-Nitroso-rivaroxaban amide / (S)-5-chloro-N-(2-hydroxy-3-(nitroso (4-(3-oxomorpholino)phenyl)amino) propyl)thiophene-2-carboxamide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
31 January 2024 | N-Nitroso-rivaroxaban open-ring acid / (S)-2-(2-((4-(5-((5-chlorothiophene-2-carboxamido)methyl)-2-oxooxazolidin-3-yl)phenyl)(nitroso)amino)ethoxy) acetic acid | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
31 January 2024 | N-Nitroso-terbinafine degradant / N-[(2E)-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-nitrosomethanamine (NTD/NHTMA) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
31 January 2024 | N-Nitroso-desmethyl-terbinafine / (E)-N-(6,6-dimethylhept-2-en-4-yn-1-yl)-N-(naphthalen-1-ylmethyl)nitrous amide (NDT/NHNA) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
31 January 2024 | N-Nitroso-terbinafine impurity A / N-methyl-N-(napthalen-1-ylmethyl)nitrous amide (NTA / NMNA) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
31 January 2024 | N-Nitroso-tetracaine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 January 2024 | N-Nitroso-urapidil | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
31 January 2024 | N‐Nitroso‐ticagrelor | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 April 2024 | 2,2,5-Trimethyl-3-nitroso-1,3-oxazolidine (TMNO) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 April 2024 | N-Nitroso terazosin impurity C / N-nitroso 6,7-dimethoxy-2-(1-piperazinyl)-4-quinazolinamine / N-nitroso 2-(1-piperazinyl)-4-amino-6, 7-dimethoxyquinazoline | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 April 2024 | N-Nitroso terazosin impurity N / (4-nitrosopiperazin-1-yl)(tetrahydrofuran-2-yl)methanone | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 April 2024 | N-Nitroso-apixaban impurity B / 5-[4-[3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-4,5-dihydropyrazolo[3,4-c]pyridin-6-yl]-N-nitrosoanilino]pentanoic acid | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 April 2024 | N-Nitroso-clozapine / 8-chloro-11-(4-methylpiperazin-1-yl)-5-nitroso-5H-dibenzo[b,e][1,4]diazepine | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 April 2024 | N-Nitroso-clozapine EP Impurity C / 8-chloro-11-(4-nitrosopiperazin-1-yl)-5H-dibenzo[b, e][1, 4]diazepine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 April 2024 | N-Nitroso-dabigatran etexilate (NDAB) | Increase AI limit from 400 ng/day to 1500 ng/day |
24 April 2024 | N-Nitroso-desmethyl-tamoxifen / (Z)-N-(2-(4-(1, 2-diphenylbut-1-en-1-yl)phenoxy)ethyl)-N-methylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
24 April 2024 | N-Nitroso-flecainide / N-((1-nitrosopiperidin-2-yl)methyl)-2, 5-bis(2, 2, 2-trifluoroethoxy)benzamide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 April 2024 | N-Nitroso-masitinib / 4-[(4-nitrosopiperazin-1-yl)methyl]-N-(4-methyl-3-{[4-(pyridin-3-yl)-1,3-thiazol-2-yl]amino}phenyl)benzamide | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 April 2024 | N-Nitroso-meropenem / (4R, 5S, 6S)-3-(((3S, 5S)-5-(dimethylcarbamoyl)-1-nitrosopyrrolidin-3-yl)thio)-6-((R)-1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 April 2024 | N-Nitroso-N-methyl-valaciclovir | Include AI limit of 400 ng/day based on CPCA potency category 3 |
24 April 2024 | N-Nitroso-ritalinic acid / 2-(1-nitrosopiperidin-2-yl)-2-phenylacetic acid | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 April 2024 | N-Nitroso-silodosin / 1-(3-hydroxypropyl)-5-[(2R)-2-[nitroso-[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-dihydroindole-7-carboxamide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
24 April 2024 | N-Nitroso-trandolapril / (2S,3aR,7aS)-1-(N-((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)-N-nitroso-L-alanyl)octahydro-1H-indole-2-carboxylic acid | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
24 April 2024 | N-Nitrosodiisopropanolamine / 1, 1'-(nitrosoimino)bis-2-propanol | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | 1-(Diphenylmethyl)-4-nitrosopiperazine / 1-benzhydryl-4-nitrosopiperazine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | 2-(4-Nitrosopiperazin-1-yl)ethanol | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | 3-((Ethyl(nitroso)amino)methyl) benzenesulfonate (N-M8) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
29 July 2024 | 3-(Dimethylamino)propyl 2-[benzyl(nitroso)amino]benzoate | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | 4-Nitroso-methyl piperazine-1-carboxylate (N-nitroso PMEC) | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | N-(2-Hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide / (R)-N-(2-hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide (MBL-2-NO) | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | N-(4-Aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide / (R)-N-(4-aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide (MBL-3-NO) | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | N-Nitroso-2-(7-methoxy-1-naphthyl)-N-[2-(7-methoxy-1-naphthyl)ethyl]ethylamine | Include AI limit of 100 ng/day based on CPCA potency category 2 |
29 July 2024 | N-Nitroso-articaine / methyl 4-methyl-3-(2-(nitroso(propyl)amino)propanamido)thiophene-2-carboxylate | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
29 July 2024 | N-Nitroso-bilastine impurity 2 / 1-(2-ethoxyethyl)-2-(1-nitrosopiperidin-4-yl)-1H-benzo[d]imidazole | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | N-Nitroso-caspofungin / (10R,12S)-N-((2R,9S,11R,12S,14aS,15S,20S,25aS)-20-((R)-3-amino-1-hydroxypropyl)-12-((2-aminoethyl)(nitroso)amino)-23-((1S,2S)-1,2-dihydroxy-2-(4-hydroxyphenyl)ethyl)-2,11,15-trihydroxy-6-((R)-1-hydroxyethyl)-5,8,14,19,22,25-hexaoxotetracosahydro-1H-dipyrrolo[2,1-c:2’,1’-l][1,4,7,10,13,16]hexaazacyclohenicosin-9-yl)-10,12-dimethyltetradecanamide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
29 July 2024 | N-Nitroso-desformyl-riociguat / N-(4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl)-N-methylnitrous | Include AI limit of 100 ng/day based on CPCA potency category 2 |
29 July 2024 | N-Nitroso-desmethyl-edoxaban / N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-(dimethylcarbamoyl)-2-(5-nitroso-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide 4-methylbenzenesulfonate | Include AI limit of 100 ng/day based on CPCA potency category 2 |
29 July 2024 | N-Nitroso-desmethyl-tramadol / N-[[(1R,2R)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]methyl]-N-methylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
29 July 2024 | N-Nitroso-desvaleryl-valsartan / (S)-2-(((2'-(1H-tetrazol-5-yl)- [1,1′-biphenyl]-4-yl) methyl)(nitroso)amino)- 3-methylbutanoic acid | Include as non-mutagenic impurity (NMI) |
29 July 2024 | N-Nitroso-fenfluramine / N-ethyl-N-[1-[3-(trifluoromethyl)phenyl]propan-2-yl]nitrous amide | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | N-Nitroso-folic acid / 2-[[4-[(2-amino-4-oxo-3H-pteridin-6-yl)methyl-nitrosoamino] benzoyl]amino]pentanedioic acid (NFA) | Change AI limit of 1500 ng/day to 1500 ng/day based on CPCA potency category 4 |
29 July 2024 | N-Nitroso-furosemide / 4-chloro-2-[furan-2-ylmethyl(nitroso)amino]-5-sulfamoylbenzoic acid | Include AI limit of 1500 ng/day |
29 July 2024 | N-Nitroso-lisinopril / N2-((S)-1-carboxy-3-phenylpropyl)-N2-nitroso-L-lysyl-L-proline | Change from AI 1500 ng/day to non-mutagenic impurity (NMI) |
29 July 2024 | N-Nitroso-N-desmethyl dextromethorphan/ (4bS,8aS,9S)-3-methoxy-11-nitroso-6,7,8,8a,9,10-hexahydro-5H-9,4b-(epiminoethano)phenanthrene (N-DEX) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
29 July 2024 | N-Nitroso-N-desmethyl-clarithromycin / N-[(2S,3R,4S,6R)-2-[[(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-ethyl-12,13-dihydroxy-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-7-methoxy-3,5,7,9,11,13-hexamethyl-2,10-dioxo-oxacyclotetradec-6-yl]oxy]-3-hydroxy-6-methyloxan-4-yl]-N-methylnitrous amide | Include as non-mutagenic impurity (NMI) |
29 July 2024 | N-Nitroso-N-desmethyl-diphenhydramine / N-(2-benzhydryloxyethyl)-N-methylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
29 July 2024 | N-Nitroso-N-ethyl-benzylamine / N-benzyl-N-ethylnitrous amide (NBEA) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
29 July 2024 | N-Nitroso-posaconazole Impurity 1 / 1-(4-(((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)-4-nitrosopiperazine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
29 July 2024 | N-Nitroso-tigecycline / (4S, 4aS, 5aR, 12aS)-9-(2-(tert-butyl(nitroso)amino)acetamido)-4, 7-bis(dimethylamino)-3, 10, 12, 12a-tetrahydroxy-1, 11-dioxo-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydrotetracene-2-carboxamide | Include as non-mutagenic impurity (NMI) |
29 July 2024 | N-Nitroso-trandolapril / (2S,3aR,7aS)-1-(N-((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)-N-nitroso-L-alanyl)octahydro-1H-indole-2-carboxylic acid | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
29 July 2024 | N-Nitroso-trientine Impurity 1 / N-(2-aminoethyl)-N-(2-((2-aminoethyl)amino)ethyl)nitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
29 July 2024 | N-Nitroso-vibegron / (S)-N-(4-(((2R,5S)-5-((R)-hydroxy(phenyl)methyl)-1-nitrosopyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxamide | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
29 July 2024 | Rivaroxaban nitroso impurity 1 / N-(2-hydroxyethyl)-N-phenyl-nitrous amide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
29 July 2024 | Rivaroxaban nitroso impurity 2 / N-(3-(1,3-dioxoisoindolin-2-yl)-2-hydroxypropyl)-N-(4-(3-oxomorpholino) phenyl)nitrous amide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
29 July 2024 | Rivaroxaban nitroso impurity 5 / N-(3-chloro-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide (N-Nitroso RVR-A) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
29 July 2024 | N-Nitroso-diisopropylamine / N,N-di(propan-2-yl)nitrous amide (DIPNA/NDIPA) | Increase AI limit from 26.5 ng/day to 1500 ng/day based on CPCA potency category 5 |
29 July 2024 | N-Nitroso-ethylisopropylamine / N-ethyl-N-propan-2-ylnitrous amide (EIPNA/NEIPA) | Increase AI limit from 26.5 ng/day to 400 ng/day based on CPCA potency category 3 |
29 July 2024 | N-Nitroso-N-methyl-4-aminobutyric acid / 4-[methyl(nitroso)amino]butanoic acid (NMBA) | Increase AI limit from 96.0 ng/day to 1500 ng/day based on CPCA potency category 4 |
29 July 2024 | 7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3-a]pyrazine (NTTP) | Increase AI limit from 37.0 ng/day to 100 ng/day based on CPCA potency category 2 |
29 July 2024 | N-Nitroso-desmethyl-citalopram / N-(3-(5-cyano-1-(4-fluorophenyl)-1, 3-dihydroisobenzofuran-1-yl)propyl)-N-methylnitrous amide | Increase AI limit from 18.0 ng/day to 100 ng/day based on CPCA potency category 2 |
15 October 2024 | N-Nitroso vildagliptin amide impurity / (S)-1-(2-(((1R, 3R, 5R, 7S)-3-hydroxyadamantan-1-yl)(nitroso)amino)acetyl)pyrrolidine-2-carboxamide | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
15 October 2024 | N-Nitroso-2,4-thiazole amine / N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide (NNTA) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
15 October 2024 | N-Nitroso-acebutolol | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
15 October 2024 | N-Nitroso-buspirone Impurity 1 / 2-(4-nitrosopiperazine-1-yl)-pyrimidine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
15 October 2024 | N-Nitroso-desmethyl-dimetindene / N-methyl-N-(2-(3-(1-(pyridin-2-yl)ethyl)-1H-inden-2-yl)ethyl)nitrous amide (NO-DDMT) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
15 October 2024 | N-Nitroso-desmethyl-rivastigmine / [3-[(1S)-1-[methyl(nitroso)amino] ethyl]phenyl] N-ethyl-N-methyl carbamate | Include AI limit of 100 ng/day based on CPCA potency category 2 |
15 October 2024 | N-Nitroso-iminodibenzyl / | Include AI limit of 78000 ng/day |
15 October 2024 | N-Nitroso-maprotiline / N-(3-(9, 10-dihydro-9, 10-ethanoanthracen-9-yl)propyl)-N-methylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
15 October 2024 | N-Nitroso-N-desmethyl-rizatriptan / N-(2-(5-((1H-1,2,4-triazol-1-yl)methyl)-1H-indol-3-yl)ethyl)-N-methylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
15 October 2024 | N-Nitroso-propafenon / N-(2-hydroxy-3-(2-(3-phenylpropanoyl)phenoxy)propyl)-N-propylnitrous amide | Include AI limit of 100 ng/day based on CPCA potency category 2 |
15 October 2024 | N-Nitroso-valsartan cyano-desvalerylmethylester / (S)-Methyl 2-(((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)(nitroso) amino)-3-methylbutanoate | Include AI limit of 100 ng/day based on CPCA potency category 2 |
15 October 2024 | N-Nitroso-vanzacaftor / (13S,Z)-26-(3-(2-(dispiro[2.0.24.13]heptan-7-yl)ethoxy)-1H-pyrazol-1-yl)-15,15-dimethyl-61,62-dihydro-5-thia-4,7-diaza-2(2,3),6(6,2)-dipyridina-1(1,3)-pyrrolidinacyclodecaphan-3-one 5,5-dioxide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
15 October 2024 | N-Nitroso-nortriptyline (NNORT) | Increase AI limit from 8.0 ng/day to 18 ng/day based on CPCA potency category 1 |
15 October 2024 | N-Nitroso-ciprofloxacin | Increase AI limit from 1500 ng/day to non-mutagenic impurity (NMI) |
15 October 2024 | N-Nitroso-diclofenac | Increase AI limit from 1500 ng/day to 78000 ng/day |
15 October 2024 | N-Nitroso-sertraline | Decrease AI limit from 1500 ng/day to 100 ng/day based on CPCA potency category 2 |
4 February 2025 | N-Nitroso-bupropion | Change from AI 1500 ng/day to non-mutagenic impurity (NMI) |
4 February 2025 | N-Nitroso-anabasine / 3-(1-nitrosopiperidin-2-yl)pyridine (NAB) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
4 February 2025 | N-Nitroso-anatabine / 3-[(2S)-1-nitroso-3,6-dihydro-2H-pyridin-2-yl]pyridine (NAT) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
4 February 2025 | N-Nitroso-nornicotine / 3-[(2S)-1-nitrosopyrrolidin-2-yl]pyridine (NNN) | Include AI limit of 100 ng/day |
4 February 2025 | N-Nitroso-desmethyl-chlorphenamine / N-(3-(4-chlorophenyl)-3-(pyridin-2-yl)propyl)-N-methylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
4 February 2025 | N-Nitroso-didecylamine | Include AI limit of 100 ng/day based on CPCA potency category 2 |
4 February 2025 | N-Nitroso-N-deshydroxyethyl-dasatinib/ | Include AI limit of 400 ng/day based on CPCA potency category 3 |
4 February 2025 | N-Nitroso-desmethyl-eletriptan / 5-[2-(benzenesulfonyl)ethyl]-3-[[(2R)-1-nitrosopyrrolidin-2-yl]methyl]-1H-indole | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
4 February 2025 | N-Nitroso-epinephrine / N-nitroso-adrenaline | Include AI limit of 100 ng/day based on CPCA potency category 2 |
4 February 2025 | N-Nitroso-desmethyl-galantamine / (4aS,6R,8aS)-3-methoxy-11-nitroso-4a,5,9,10,11,12-hexahydro-6H-benzo[2,3]benzofuro[4,3-cd]azepin-6-ol | Include AI limit of 18 ng/day based on CPCA potency category 1 |
4 February 2025 | N‐Nitroso‐ivacaftor / N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1-nitroso-4-oxo-1,4-dihydroquinoline-3-carboxamide | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
4 February 2025 | N-Nitroso-nor-oxycodone / (4R,4aS,7aS,12bS)-4a,9-dihydroxy-3-nitroso-2,3,4,4a,5,6-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7aH)-one | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
4 February 2025 | N-Nitroso-nilotinib / 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(nitroso(4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
4 February 2025 | N-Nitroso-L-prolinamide / (S)-1-nitrosopyrrolidine-2-carboxamide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
4 February 2025 | N-Nitroso-L-prolinenitrile / (S)-1-nitrosopyrrolidine-2-carbonitrile | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
4 February 2025 | N‐Nitroso‐desmethyl‐zolmitriptan / N-methyl-N-[2-[5-[[(4S)-2-oxo-1,3-oxazolidin-4-yl]methyl]-1H-indol-3-yl]ethyl]nitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
24 January 2025 | N-Nitroso-biotin / 5-((3aS,4S,6aR)-1-nitroso-2-oxohexahydro-1H-thieno[3,4-d]imidazol-4-yl)pentanoic acid | Include AI limit of 1500 ng/day |
24 January 2025 | N-Nitroso-cimetidine / 3-cyano-1-methyl-2-[2-[(5-methyl-1H-imidazol-4-yl)methylsulfanyl]ethyl]-1-nitrosoguanidine | Include AI limit of 553 ng/day |
24 January 2025 | N-Nitroso-clonidine / N-(2,6-dichlorophenyl)-1-nitroso-4,5-dihydroimidazol-2-amine | Include AI limit of 553 ng/day |
24 January 2025 | N-Nitroso-clonidine-2 / N-(2,6-dichlorophenyl)-N-(4,5-dihydro-1H-imidazol-2-yl)nitrous amide | Include AI limit of 553 ng/day |
24 January 2025 | N-Nitroso-eletriptan / (S)-3-((1-methylpyrrolidin-2-yl)methyl)-1-nitroso-5-(2-(phenylsulfonyl)ethyl)-1H-indole | Include AI limit of 1500 ng/day |
24 January 2025 | N-Nitroso-melatonin / N-(2-(5-methoxy-1-nitroso-1H-indol-3-yl)ethyl)acetamide | Include AI limit of 1500 ng/day |
24 January 2025 | 1-Nitroso-moxonidine / N-(4-chloro-6-methoxy-2-methylpyrimidin-5-yl)-N-(4,5-dihydro-1H-imidazol-2-yl)nitrous amide | Include AI limit of 553 ng/day |
24 January 2025 | 1-Nitroso-moxonidine Impurity 3 / 4-chloro-6-methoxy-2-methyl-N-(1-nitroso-4,5-dihydro-1H-imidazol-2-yl)pyrimidin-5-amine | Include AI limit of 553 ng/day |
24 January 2025 | N-Nitroso-naraptriptan / N-methyl-2-[3-(1-methylpiperidin-4-yl)-1-nitrosoindol-5-yl]ethanesulfonamide | Include AI limit of 1500 ng/day |
24 January 2025 | N-Nitroso-sumatriptan / 1-(3-(2-(dimethylamino)ethyl)-1-nitroso-1H-indol-5-yl)-N-methylmethanesulfonamide | Include AI limit of 1500 ng/day |
24 January 2025 | N-Nitroso-rizatriptan / 2-(5-((1H-1,2,4-triazol-1-yl)methyl)-1-nitroso-1H-indol-3-yl)-N,N-dimethylethan-1-amine | Include AI limit of 1500 ng/day |
24 January 2025 | N-Nitroso-tadalafil / (2R,8R)-2-(1,3-benzodioxol-5-yl)-6-methyl-17-nitroso-3,6,17-triazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione | Include AI limit of 1500 ng/day |
24 January 2025 | N-Nitroso-tizanidine / N-(5-chlorobenzo[c][1,2,5]thiadiazol-4-yl)-N-(4,5-dihydro-1H-imidazol-2-yl)nitrous amide | Include AI limit of 553 ng/day |
24 January 2025 | N-Nitroso-tizanidine Impurity 3 / N-(5-chlorobenzo[c][1,2,5]thiadiazol-4-yl)-N-(4,5-dihydro-1H-imidazol-2-yl)nitrous amide | Include AI limit of 553 ng/day |
24 January 2025 | N-Nitroso-tryptophol / 2-(1-nitrosoindol-3-yl)ethanol | Include AI limit of 1500 ng/day |
24 January 2025 | N-Nitroso-zolmitriptan / (4S)-4-[[3-[2-(dimethylamino)ethyl]-1-nitrosoindol-5-yl]methyl]-1,3-oxazolidin-2-one | Include AI limit of 1500 ng/day |
24 January 2025 | N-Methyl-N’-nitro-N-nitrosoguanidine / 1-methyl-3-nitro-1-nitrosoguanidine (MNNG) | Include AI limit of 553 ng/day |
30 April 2025 | N-Nitroso-desmethyl-cabergoline / (6aR,9R,10aR)-7-allyl-N-(ethylcarbamoyl)-N-(3-(methyl(nitroso)amino)propyl)-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxamide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
30 April 2025 | N-Nitroso-dalbavancin / (2S,3S,4R,5R,6S)-6-[[(1S,2R,19R,22R,34S,37R,40R,52R)-5,32-dichloro-52-[3-(dimethylamino)propylcarbamoyl]-2,26,31,44,49-pentahydroxy-22-[methyl(nitroso)amino]-21,35,38,54,56,59-hexaoxo-47-[(2R,3S,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-7,13,28-trioxa-20,36,39,53,55,58-hexazaundecacyclo[38.14.2.23,6.214,17.219,34.18,12.123,27.129,33.141,45.010,37.046,51]hexahexaconta-3,5,8,10,12(64),14(63),15,17(62),23(61),24,26,29(60),30,32,41(57),42,44,46(51),47,49,65-henicosaen-64-yl]oxy]-3,4-dihydroxy-5-(10-methylundecanoylamino)oxane-2-carboxylic acid | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
30 April 2025 | N-Nitroso-dasatinib / N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)(nitroso)amino)thiazole-5-carboxamide | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
30 April 2025 | N-Nitroso-desmethyl-lercanidipine / 3-(1-((3,3-diphenylpropyl)(nitroso)amino)-2-methylpropan-2-yl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate | Include AI limit of 100 ng/day based on CPCA potency category 2 |
30 April 2025 | N-Nitroso-desmethyl-lercanidipine impurity C / 3-(1-((3,3-diphenylpropyl)(nitroso)amino)-2-methylpropan-2-yl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate | Include AI limit of 100 ng/day based on CPCA potency category 2 |
30 April 2025 | N-Nitroso-N-desmethyl-mianserin / 2-nitroso-1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
30 April 2025 | N-Nitroso-nirogacestat / (S)-2-(((S)-6, 8-difluoro-1, 2, 3, 4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentyl(nitroso)amino)propan-2-yl)-1H-imidazol-4-yl)pentanamide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
30 April 2025 | 2-(N-Nitrosomethylamino)-N-[6-(trifluoromethoxy)-1,3-benzothiazol-2-yl]acetamide (NNT) | Include AI limit of 100 ng/day based on CPCA potency category 2 |
30 April 2025 | N-Nitroso-sarcosine / 2-[methyl(nitroso)amino]acetic acid (NSAR) | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
30 April 2025 | N-Nitroso-vancomycin / (1S,2R,18R,19R,22S,25R,28R,40S)-48-[(2S,3R,4S,5S,6R)-3-[(2S,4S,5S,6S)-4-amino-5-hydroxy-4,6-dimethyloxan-2-yl]oxy-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-22-(2-amino-2-oxoethyl)-5,15-dichloro-2,18,32,35,37-pentahydroxy-19-[[(2R)-4-methyl-2-[methyl(nitroso)amino]pentanoyl]amino]-20,23,26,42,44-pentaoxo-7,13-dioxa-21,24,27,41,43-pentazaoctacyclo[26.14.2.23,6.214,17.18,12.129,33.010,25.034,39]pentaconta-3,5,8(48),9,11,14,16,29(45),30,32,34(39),35,37,46,49-pentadecaene-40-carboxylic acid | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
31 July 2025 | N-Nitroso-acarbose / N-nitroso-4,6-dideoxy-4-[(1S,2S,3R,4S,5S)-3,4,5-trihydroxy-2-(hydroxymethyl)cyclohexyl]-α-D-glucopyranosyl-(1→4)-α-D-glucopyranosyl-(1→4)-α-D-glucopyranosyl-(1→4)-D-glucopyranose | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
31 July 2025 | N-Nitroso-benzathine / N-nitroso-N,N'-dibenzylethanediamine / N-benzyl-N-(2-(benzylamino)ethyl)nitrous amide (NNB) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
31 July 2025 | N-Nitroso-brinzolamide / (R)-4-(ethyl(nitroso)amino)-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide | Include AI limit of 100 ng/day based on CPCA potency category 2 |
31 July 2025 | N-Nitroso-carvedilol / N-(3-((9H-carbazol-4-yl)oxy)-2-hydroxypropyl)-N-(2-(2-methoxyphenoxy)ethyl)nitrous amide | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 July 2025 | N-Nitroso-frovatriptan / (6R)-6-[methyl(nitroso)amino]-6,7,8,9-tetrahydro-5H-carbazole-3-carboxamide | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 July 2025 | N-Nitroso-nebivolol (NNEB) | Change from AI 1500 ng/day to non-mutagenic impurity (NMI) |
31 July 2025 | N-Nitroso-despropyl-ropinirole / N-(2-(2-oxoindolin-4-yl)ethyl)-N-propylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
31 July 2025 | N-Nitroso-safinamide / (2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methyl-nitrosoamino]propanamide | Include AI limit of 400 ng/day based on CPCA potency category 3 |
31 July 2025 | N-Nitroso-nirogacestat / (S)-2-(((S)-6, 8-difluoro-1, 2, 3, 4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentyl(nitroso)amino)propan-2-yl)-1H-imidazol-4-yl)pentanamide | Removed from the AI list aligning with the EMA |
31 July 2025 | N-Nitroso-norfloxacin / 1-ethyl-6-fluoro-7-(4-nitrosopiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid | Include as non-mutagenic impurity (NMI) |
3 November 2025 | N-Nitroso-berotralstat / (R)-1-(3-(aminomethyl)phenyl)-N-(5-((3-cyanophenyl)((cyclopropylmethyl) (nitroso)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide | Include AI limit of 100 ng/day based on CPCA potency category 2 |
3 November 2025 | N-Nitroso-desmethyl-doxylamine / N-methyl-N-(2-(1-phenyl-1-(pyridin-2-yl)ethoxy)ethyl)nitrous amide | Include AI limit of 100 ng/day |
3 November 2025 | N-Nitroso-doravirine dimer (NDD) | Include AI limit of 1500 ng/day |
3 November 2025 | N-Nitroso hydroxychloroquine EP Impurity C / N-(4-((7-chloroquinolin-4-yl)amino)pentyl)-N-(2-hydroxyethyl)nitrous amide | Include AI limit of 100 ng/day based on CPCA potency category 2 |
3 November 2025 | N-Nitroso hydroxychloroquine EP Impurity D / N-(4-((7-chloroquinolin-4-yl)amino)pentyl)-N-ethylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
3 November 2025 | N-Nitroso-hydroxyzine Impurity A / 1-((4-chlorophenyl)(phenyl)methyl)-4-nitrosopiperazine | Include AI limit of 400 ng/day based on CPCA potency category 3 |
3 November 2025 | N-Nitroso-methylaminoantipyrine / N-(1,5-dimethyl-3-oxo-2-phenylpyrazol-4-yl)-N-methylnitrous amide (NMAA) | Include AI limit of 100 ng/day based on CPCA potency category 2 |
3 November 2025 | N-Nitroso-methylethanolamine / N-(2-hydroxyethyl)-N-methylnitrous amide (NMELA) | Include AI limit of 100 ng/day based on CPCA potency category 2 |
3 November 2025 | N-Nitroso-mirdametinib / N-(2,3-dihydroxypropoxy)-3,4-difluoro-2-((2-fluoro-4-iodophenyl)(nitroso)amino)benzamide | Include AI limit of 78000 ng/day |
3 November 2025 | N-Nitroso-nirogacestat / (S)-2-(((S)-6, 8-difluoro-1, 2, 3, 4-tetrahydronaphthalen-2-yl)amino)-N-(1-(2-methyl-1-(neopentyl(nitroso)amino)propan-2-yl)-1H-imidazol-4-yl)pentanamide | Include AI limit of 1500 ng/day |
3 November 2025 | N-Nitroso-nirogacestat impurity 1 / (S)-2-(((S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)(nitroso)amino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
3 November 2025 | N-Nitroso-propafenone impurity B / (R,E)-N-(3-(2-cinnamoylphenoxy)-2-hydroxypropyl)-N-propylnitrous amide | Include AI limit of 100 ng/day based on CPCA potency category 2 |
3 November 2025 | N-Nitroso venlafaxine EP Impurity D / N-(2-(1-hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-methylnitrous amide | Include AI limit of 18 ng/day based on CPCA potency category 1 |
3 November 2025 | N-Nitroso venlafaxine EP Impurity H / N-(2-(1-hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-(4-methoxyphenethyl)nitrous amide | Include AI limit of 100 ng/day based on CPCA potency category 2 |
3 November 2025 | N-Nitroso-desmethyl-almotriptan | Include AI limit of 18 ng/day based on CPCA potency category 1 |
3 November 2025 | N-Nitroso-N-desethyl-amiodarone | Include AI limit of 18 ng/day based on CPCA potency category 1 |
3 November 2025 | (2S,4R)-N-(6-Bromopyridin-2-yl)-4-fluoro-1-nitrosopyrrolidine-2-carboxamide | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
3 November 2025 | N-Nitroso‐N-desmethyl‐diltiazem | Include AI limit of 100 ng/day |
3 November 2025 | N-Nitroso-nadolol | Include AI limit of 1500 ng/day based on CPCA potency category 5 |
3 November 2025 | 1-Methyl-4-nitrosopiperazine (MeNP/MNP) | Include AI limit of 400 ng/day based on CPCA potency category 3 |
3 November 2025 | N-Nitroso-2,6-pipecoloxilidide / desbutyl bupivacaine nitroso impurity | Include AI limit of 1500 ng/day based on CPCA potency category 4 |
3 November 2025 | N-Nitroso-diethylamine (NDEA) | Include AI limit of 26.5 ng/day |
3 November 2025 | N-Nitroso-morpholine (NMOR) | Include AI limit of 127.0 ng/day |
3 November 2025 | N-Nitroso-2,4-thiazole amine / N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide (NNTA) | Include AI limit of 18 ng/day based on CPCA potency category 1 |
Established acceptable intake for other N-nitroso-structures in medicines table.