Established acceptable intake for nitrosamines in medicines

Default class specific threshold of toxicological concern TTC

-

18.0

Default limit

-

3-((Ethyl(nitroso)amino)methyl) benzenesulfonate

(N-M8)

Dextromethorphan

18

1

29 July 2024

N-Nitroso-N-ethyl-benzylamine /
N-benzyl-N-ethylnitrous amide

(20689-96-7, NBEA)

-

18

1

29 July 2024

1-Methyl-4-nitrosopiperazine

(16339-07-4, MeNP/MNP)

Rifampicin

400

3

20 July 2022

Updated 24 August 2023

1-Nitroso-pyrrolopiperidine

-

1500

4

24 August 2023

2-Nitroso-octahydrocyclopenta(c)pyrrole

(54786-86-6)

Gliclazide

1700

24 August 2023

3-Amino-N-nitrosopiperidine

(2819242-71-0)

Alogliptin

400

3

16 October 2023

4-(Methylnitrosoamino)-1-(3-pyridinyl)-1-butanone

(64091-91-4, NNK)

-

100

5 January 2023

7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3-a]pyrazine

(2892260-32-9, NTTP)

Sitagliptin

100

2

20 July 2022

Updated 29 July 2024

Nitroso impurity C” [N-(2,6-dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide]

Ranolazine

400

3

24 August 2023

N-Nitroso-orphenadrine

(NMOA)

Orphenadrine

18

1

24 August 2023

N-Nitroso-praziquanamine / 
[2-nitroso-2,3,6,7-tetrahydro-1H-pyrazino[2,1-a]isoquinolin-4(11bH)-one]

(115822-46-3)

Arpraziquantel

1500

4

24 August 2023

N-Methyl-N-nitrosophenethylamine

(13256-11-6, NMPEA)

-

8.0

5 January 2023

N-Nitroso-1,2,3,6-tetrahydropyridine

(55556-92-8, NTHP)

-

37.0

20 July 2022

N-Nitroso derivative of rotigotine impurity B /
N-(5-hydroxy-1,2,3,4-tetrahydronaphthalen-2-yl)-N-propylnitrous amide

Rotigotine

400

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

Rotigotine

1500

4

16 October 2023

N-Nitroso-2,6-pipecoloxilidide

Ropivacaine

1500

4

24 August 2023

N-Nitroso-acebutolol

Acebutolol

1500

4

15 October 2024

N-Nitroso-2-(7-methoxy-1-naphthyl)-N-[2-(7-methoxy-1-naphthyl)ethyl]ethylamine

Agomelatine

100

2

29 July 2024

N-Nitroso-ambroxol

Ambroxol

1500

24 August 2023

Updated 31 January 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

Apixaban

1500

4

24 April 2024

1-(2,3-Dichlorophenyl)-4-nitrosopiperazine

(2221987-86-4)

Aripiprazole

400

3

31 January 2024

N-Nitroso-articaine /
methyl 4-methyl-3-(2-(nitroso(propyl)amino)propanamido)thiophene-2-carboxylate

Articaine

1500

4

29 July 2024

N-Nitroso-aryl piperazine /
N-nitroso-desalkylquetiapine

(NDAQ)

Quetiapine

400

3

24 August 2023

N-Nitroso-atomoxetine

Atomoxetine

100

24 August 2023

N-Nitroso-atenolol

(134720-04-0)

Atenolol

1500

4

24 August 2023

N-Nitroso-azacyclonol

(1038-06-8)

Azacyclonol

400

3

31 January 2024

N-Nitroso-desmethyl-azelastine

Azelastine

100

2

31 January 2024

N-Nitroso-azithromycin

Azithromycin

NMI

24 August 2023

N-Nitroso-benazepril

Benazepril

1500

5

24 August 2023

3-(Dimethylamino)propyl 2-[benzyl(nitroso)amino]benzoate

Benzydamine

400

3

29 July 2024

N-Nitroso-betahistine

(32635-81-7)

Betahistine

18

1

24 August 2023

N-Nitroso-betaxolol

Betaxolol

1500

4

31 January 2024

N-Nitroso-bilastine impurity 2 /
1-(2-ethoxyethyl)-2-(1-nitrosopiperidin-4-yl)-1H-benzo[d]imidazole

Bilastine

400

3

29 July 2024

N-Nitroso-bisoprolol

(2820170-76-9, NBP)

Bisoprolol

1500

4

24 August 2023

N-Nitroso-bumetanide

(2490432-02-3, NNB)

Bumetanide

1500

4

24 August 2023

N-Nitroso-bupropion /
N-tert-butyl-N-[1-(3-chlorophenyl)-1-oxopropan-2-yl]nitrous amide

(2763780-10-3)

Bupropion

NMI

24 August 2023

Updated 4 February 2025

N-Nitroso-buspirone Impurity 1 /
2-(4-nitrosopiperazine-1-yl)-pyrimidine

(872826-80-7)

Buspirone

400

3

15 October 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

Caspofungin

1500

4

29 July 2024

N-Nitroso-celiprolol

Celiprolol

1500

5

31 January 2024

N-Nitroso-cilazapril

(1053740-92-3)

Cilazapril

1500

5

24 August 2023

N-Nitroso-cinacalcet

Cinacalcet

400

3

31 January 2024

1-(Diphenylmethyl)-4-nitrosopiperazine /
1-benzhydryl-4-nitrosopiperazine

(1698-25-5)

Cinnarizine

400

3

29 July 2024

N-Nitroso-ciprofloxacin

(864443-44-7)

Ciprofloxacin

NMI

24 August 2023

Updated 15 October 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

Clarithromycin

NMI

29 July 2024

N-Nitroso-clozapine /
8-chloro-11-(4-methylpiperazin-1-yl)-5-nitroso-5H-dibenzo[b,e][1,4]diazepine

(156632-03-0)

Clozapine

1500

5

24 April 2024

N-Nitroso-clozapine EP Impurity C /
8-chloro-11-(4-nitrosopiperazin-1-yl)-5H-dibenzo[b, e][1, 4]diazepine

Clozapine

400

3

24 April 2024

N-Nitroso-didecylamine

Colesevelam

100

2

4 February 2025

2,2,5-Trimethyl-3-nitroso-1,3-oxazolidine

(77400-46-5, TMNO)

Cyanocobalamine

1500

4

24 April 2024

N-Nitroso-dabigatran etexilate

(NDAB)

Dabigatran etexilate

1500

5 January 2023 Updated 24 August 2023 and 24 April 2024

5-Chloro-4-methyl-2-[(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]-1H-benzimidazole

(IDOR-1135-8758)

Daridorexant

1500

5

31 January 2024

N-Nitroso-N-deshydroxyethyl-dasatinib

Dasatinib

400

3

4 February 2025

N-Nitroso-desloratadine

(1246819-22-6)

Desloratadine

400

3

24 August 2023

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)

Dextromethorphan

1500

4

29 July 2024

N-Nitroso-desmethyl-dimetindene /
N-methyl-N-(2-(3-(1-(pyridin-2-yl)ethyl)-1H-inden-2-yl)ethyl)nitrous amide

(NO-DDMT)

Dimetindene

18

1

15 October 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

Edoxaban

100

2

29 July 2024

N-Nitroso-desmethyl trimebutine

Trimebutine

1500

5

24 August 2023

N-Nitroso-trientine Impurity 1 /
N-(2-aminoethyl)-N-(2-((2-aminoethyl)amino)ethyl)nitrous amide

(2817316-41-7)

Trientine

18

1

29 July 2024

N-Nitroso-desmethylazithromycin

Azithromycin

NMI

24 August 2023

N-Nitroso-desmethyl-chloropyramine

(N-DMCP)

Chloropyramine

18

1

24 August 2023

N-Nitroso-desmethyl-chlorphenamine /
N-(3-(4-chlorophenyl)-3-(pyridin-2-yl)propyl)-N-methylnitrous amide

Chlorphenamine

18

1

4 February 2025

N-Nitroso-desmethyl-citalopram /
N-(3-(5-cyano-1-(4-fluorophenyl)-1, 3-dihydroisobenzofuran-1-yl)propyl)-N-methylnitrous amide

Citalopram

100

31 January 2024

Updated 29 July 2024

N-Nitroso-desmethyl-tripelennamine

Tripelennamine

18

1

24 August 2023

N-Nitroso-desvenlafaxine

Desvenlafaxine

18

1

31 January 2024

N-Nitroso-diclofenac

(66505-80-4)

Diclofenac

78000

24 August 2023

Updated 15 October 2024

N-Nitroso-diethanolamine

(1116-54-7, NDELA)

-

1900

5 January 2023

N-Nitroso-diethylamine

(55-18-5, NDEA)

-

26.5

15 September 2019

N-Nitroso-diisopropylamine /
N,N-di(propan-2-yl)nitrous amide

(601-77-4, DIPNA/NDIPA)

-

1500

5

15 September 2019

Updated 29 July 2024

N-Nitrosodiisopropanolamine /
1, 1'-(nitrosoimino)bis-2-propanol

(53609-64-6)

-

400

3

24 April 2024

N-Nitroso-dimethylamine

(62-75-9, NDMA)

-

96.0

15 September 2019

N-Nitroso-di-n-butylamine

(924-16-3, NDBA)

-

26.5

20 July 2022

N-Nitroso-N-desmethyl-diphenhydramine /
N-(2-benzhydryloxyethyl)-N-methylnitrous amide

(55855-43-1)

Diphenhydramine / Dimenhydrinate

18

1

29 July 2024

N-Nitroso-diphenylamine

(86-30-6, NDPh)

-

78000

5 January 2023

N-Nitroso-dipropylamine

(621-64-7, NDPA)

-

26.5

20 July 2022

N-Nitroso-dorzolamide

Dorzolamide

1500

31 January 2024

N-Nitroso-duloxetine

(2680527-91-5, NDLX)

Duloxetine

100.0

20 July 2022

N-Nitroso-desmethyl-eletriptan /
5-[2-(benzenesulfonyl)ethyl]-3-[[(2R)-1-nitrosopyrrolidin-2-yl]methyl]-1H-indole

Eletriptan

1500

4

4 February 2025

N-Nitroso-enalapril

Enalapril

1500

5

24 August 2023

N-Nitroso-epinephrine / N-nitroso-adrenaline

Epinephrine / Adrenaline

100

2

4 February 2025

N-Nitroso-esmolol

Esmolol

1500

4

31 January 2024

N-Nitroso-ethylisopropylamine /
N-ethyl-N-propan-2-ylnitrous amide

(16339-04-1, EIPNA/NEIPA)

-

400

3

15 September 2019

Updated 29 July 2024

N-Nitroso-felodipine

Felodipine

1500

5

24 August 2023

N-Nitroso-fenfluramine /
N-ethyl-N-[1-[3-(trifluoromethyl)phenyl]propan-2-yl]nitrous amide

(19023-40-6)

Fenfluramine

400

3

29 July 2024

N-Nitroso-flecainide /
N-((1-nitrosopiperidin-2-yl)methyl)-2, 5-bis(2, 2, 2-trifluoroethoxy)benzamide

(2901109-58-6)

Flecainide

1500

4

24 April 2024

N-Nitrosofluoxetine

(150494-06-7)

Fluoxetine

100

5 January 2023

N-Nitroso-folic acid /
2-[[4-[(2-amino-4-oxo-3H-pteridin-6-yl)methyl-nitrosoamino] benzoyl]amino]pentanedioic acid

(26360-21-4, NFA)

Folic acid

1500

4

24 August 2023

Updated 29 July 2024

N-Nitroso-calcium folinate

Calcium folinate / Calcium levofolinate

NMI

31 January 2024

N-Nitroso-furosemide /
4-chloro-2-[furan-2-ylmethyl(nitroso)amino]-5-sulfamoylbenzoic acid

(2708280-93-5)

Furosemide

1500

29 July 2024

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

Galantamine

18

1

4 February 2025

N-Nitroso-hydrochlorothiazide

(63779-86-2, NHCTZ)

Hydrochlorothiazide

NMI

24 August 2023

N-Nitroso imatinib

Imatinib

1500

5

31 January 2024

Indapamide impurity A /
2-methyl-1-nitroso-2,3-dihydroindole

(85440-79-5)

Indapamide

1500

5

31 January 2024

N-Nitroso-ethylenediamine-triacetic acid

(862542-34-5)

Isosorbide mononitrate

1500

4

31 January 2024

N-Nitroso-iminodiacetic acid

(25081-31-6)

Isosorbide mononitrate

1500

4

31 January 2024

N‐Nitroso‐ivacaftor /
N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1-nitroso-4-oxo-1,4-dihydroquinoline-3-carboxamide

Ivacaftor

1500

5

4 February 2025

N-Nitroso-ketamine /
N-[1-(2-chlorophenyl)-2-oxocyclohexyl]-N-methylnitrous amide

(86144-35-6)

Ketamine

1500

5

24 August 2023

N-Nitroso-labetalol

(2820170-74-7)

Labetalol

1500

4

24 August 2023

N-Nitroso-landiolol

Landiolol

400

3

24 August 2023

N-Nitroso-leniolisib

Leniolisib

1500

5

31 January 2024

N-Nitroso-levofloxacin

(1152314-62-9)

Levofloxacin

1500

4

24 August 2023

N-Nitroso-desethyllidocaine

Lidocaine / Lignocaine

100

2

31 January 2024

N-Nitroso-lisinopril /
N2-((S)-1-carboxy-3-phenylpropyl)-N2-nitroso-L-lysyl-L-proline

(519175-80-5, NLP)

Lisinopril

NMI

24 August 2023

Updated 29 July 2024

N-Nitroso-maprotiline /
N-(3-(9, 10-dihydro-9, 10-ethanoanthracen-9-yl)propyl)-N-methylnitrous amide

(204268-61-1)

Maprotiline

18

1

15 October 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

Masitinib

400

3

24 April 2024

N-Nitroso-mefenamic acid

(2114-63-8)

Mefenamic acid

78000

5 January 2023

N-Nitroso-iminodibenzyl /
10,11-dihydro-5-nitroso-5H-dibens[b,f]azepine /
2‐nitroso‐2‐azatricyclo[9.4.0.0³,⁸] pentadeca‐1(11),3(8),4,6,12,14‐hexaene)

(7458-08-4)

Melipramin (Imipramine)

78000

15 October 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

Meropenem

1500

4

24 April 2024

N-Nitroso-methylphenidate

(55557-03-4, NMPH)

Methylphenidate

1300

20 July 2022

N-Nitroso-ritalinic acid /
2-(1-nitrosopiperidin-2-yl)-2-phenylacetic acid

Methylphenidate

1500

4

24 April 2024

N-Nitroso-metoprolol

(138768-62-4)

Metoprolol

1500

4

24 August 2023

N-Nitroso-mirabegron

Mirabegron

400

3

24 August 2023

N-(2-Hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide /
(R)-N-(2-hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide

(MBL-2-NO)

Mirabegron

400

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)

Mirabegron

400

3

29 July 2024

N-Nitroso-mirtazapine

Mirtazapine

400

3

31 January 2024

N-Nitroso-morpholine

(59-89-2, NMOR)

-

127.0

20 July 2022

N-Nitroso-moxifloxacin

Moxifloxacin

1500

4

24 August 2023

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

Nalmefene

1500

4

4 February 2025

N-Nitroso-nebivolol

(1391051-68-5, NNEB)

Nebivolol

1500

4

24 August 2023

N-Nitroso-anabasine /
3-(1-nitrosopiperidin-2-yl)pyridine

(37620-20-5, NAB)

Nicotine

1500

4

4 February 2025

N-Nitroso-anatabine /
3-[(2S)-1-nitroso-3,6-dihydro-2H-pyridin-2-yl]pyridine

(71267-22-6, NAT)

Nicotine

1500

4

4 February 2025

N-Nitroso-nornicotine /
3-[(2S)-1-nitrosopyrrolidin-2-yl]pyridine

(16543-55-8, NNN)

Nicotine

100

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

(2925306-68-7)

Nilotinib

1500

5

4 February 2025

N-Nitroso desmethyl nintedanib

Nintedanib

400

3

31 January 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

Posaconazole

400

3

29 July 2024

N-Nitroso-propafenon /
N-(2-hydroxy-3-(2-(3-phenylpropanoyl)phenoxy)propyl)-N-propylnitrous amide

Propafenon

100

2

15 October 2024

N-Nitroso-N-ethyl-valaciclovir

Valaciclovir

400

3

24 August 2023

N-Nitroso-N-methyl-valaciclovir

Valaciclovir

400

3

24 April 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

Vibegron

1500

5

29 July 2024

N-Nitroso-N-methyl-4-aminobutyric acid /
4-[methyl(nitroso)amino]butanoic acid

(61445-55-4, NMBA)

-

1500

4

15 September 2019

Updated 29 July 2024

N-Nitroso-N-methylaniline /
N-methyl-N-phenylnitrous amide

(614-00-6, NMPA)

-

100

2

31 January 2024

N-Nitroso-nortriptyline

(55855-42-0, NNORT)

Amitriptyline, Nortriptyline

18

1

20 July 2022

Updated 15 October 2024

4-Nitroso-methyl piperazine-1-carboxylate

(N-nitroso PMEC)

Omecamtiv mecarbil

400

3

29 July 2024

2-(4-Nitrosopiperazin-1-yl)ethanol

(48121-20-6)

Opipramol

400

3

29 July 2024

N-Nitroso-paroxetine

(2361294-43-9)

Paroxetine

1300

5 January 2023

N-Nitroso-p-chloro-benzylamino-pyridine

(N-CBAP)

Chloropyramine

100

2

24 August 2023

N-Nitroso-perindopril

Perindopril

1500

5

24 August 2023

N-Nitroso-phenylephrine

(78658-64-7)

Phenylephrine

100

2

24 August 2023

N-Nitroso-piperazine

(5632-47-3, NPZ)

-

400

3

24 August 2023

N-Nitrosopiperidine

(100-75-4)

-

1300

20 July 2022

N-Nitroso-pramipexole

Pramipexole

400

3

24 August 2023

N-Nitroso-propranolol

(84418-35-9)

Propranolol

1500

4

24 August 2023

N-Nitroso-pseudoephedrine

(1850-88-0)

Pseudoephedrine

1500

4

24 August 2023

N-Nitroso-pyrrolidine

(930-55-2, NPYR)

-

1700

5 January 2023

N-Nitroso quetiapine HEEP impurity /
2-(2-(4-nitrosopiperazin-1-yl)ethoxy)ethan-1-ol

(73486-81-4)

Quetiapine

1500

31 January 2024

N-Nitroso-quinapril

Quinapril

NMI

24 August 2023

N-Nitroso-ramipril

Ramipril

1500

5

24 August 2023

N-nitroso ranolazine impurity 1 /
1-(2-methoxyphenoxy)-3-(4-nitrosopiperazin-1-yl)propan-2-ol

Ranolazine

400

3

31 January 2024

N-Nitrosorasagiline

(2470278-90-9) 

Rasagiline

100

2

20 July 2022

Updated 24 August 2023

N-Nitroso-reboxetine

Reboxetine

127

24 August 2023

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

Ribociclib

400

3

31 January 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

Riociguat

100

2

29 July 2024

N-Nitroso-2,4-thiazole amine /
N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide

(NNTA)

Ritonavir

18

1

15 October 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

Rivaroxaban

1500

4

31 January 2024

N-Nitroso-rivaroxaban amide /
(S)-5-chloro-N-(2-hydroxy-3-(nitroso (4-(3-oxomorpholino)phenyl)amino) propyl)thiophene-2-carboxamide

Rivaroxaban

1500

4

31 January 2024

Rivaroxaban Nitroso Impurity 1 /
N-(2-hydroxyethyl)-N-phenyl-nitrous amide
(25413-76-7, N-Nitroso KCR-1)

Rivaroxaban

1500

4

29 July 2024

Rivaroxaban Nitroso Impurity 2 /
N-(3-(1,3-dioxoisoindolin-2-yl)-2-hydroxypropyl)-N-(4-(3-oxomorpholino) phenyl)nitrous amide

Rivaroxaban

1500

4

29 July 2024

Rivaroxaban Nitroso Impurity 5 /
N-(3-chloro-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amide

(N-Nitroso RVR-A)

Rivaroxaban

1500

4

29 July 2024

N-Nitroso-desmethyl-rivastigmine /
[3-[(1S)-1-[methyl(nitroso)amino] ethyl]phenyl] N-ethyl-N-methyl carbamate

Rivastigmine

100

2

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

Rizatriptan

18

1

15 October 2024

N-Nitroso-salbutamol

(2919946-71-5)

Salbutamol

1500

5

24 August 2023

N-Nitroso-sertraline

Sertraline

100

2

24 August 2023

Updated 16 October 2023

Updated 15 October 2024

N-Nitroso-desmethyl-sildenafil

Sildenafil

400

3

31 January 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

Silodosin

1500

4

24 April 2024

N-Nitroso-sotalol

(134720-07-3)

Sotalol

1500

4

24 August 2023

N-Nitroso-desmethyl sumatriptan

Sumatriptan

18

1

31 January 2024

N-Nitroso-desmethyl-tamoxifen /
(Z)-N-(2-(4-(1, 2-diphenylbut-1-en-1-yl)phenoxy)ethyl)-N-methylnitrous amide

Tamoxifen

18

1

24 April 2024

N-Nitroso-tamsulosin

(2892260-31-8)

Tamsulosin

1500

4

20 July 2022

Updated 24 August 2023

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

Terazosin

400

3

24 April 2024

N-Nitroso terazosin impurity N /
(4-nitrosopiperazin-1-yl)(tetrahydrofuran-2-yl)methanone

(2470438-57-2)

Terazosin

400

3

24 April 2024

N-Nitroso-desmethyl-terbinafine /
(E)-N-(6,6-dimethylhept-2-en-4-yn-1-yl)-N-(naphthalen-1-ylmethyl)nitrous amide

(NDT / NHNA)

Terbinafine

18

1

31 January 2024

N-Nitroso-terbinafine impurity A
N-methyl-N-(napthalen-1-ylmethyl)nitrous amide

(296760-88-8, NTA / NMNA)

Terbinafine

18

1

31 January 2024

N-Nitroso-terbinafine degradant
N-[(2E)-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-nitrosomethanamine

(NTD / NHMA)

Terbinafine

18

1

31 January 2024

N-Nitroso-tetracaine

Tetracaine

400

3

31 January 2024

N‐Nitroso‐ticagrelor

(2476859-55-7)

Ticagrelor

1500

5

31 January 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

Tigecycline

NMI

29 July 2024

N-Nitroso-desmethyl-tramadol /
N-[[(1R,2R)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]methyl]-N-methylnitrous amide

Tramadol

18

1

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

Trandolapril

1500

5

29 July 2024

N-Nitroso-trimetazidine

(92432-50-3, NTMZ)

Trimetazidine

400

3

24 August 2023

N-Nitroso-urapidil

Urapidil

1500

4

31 January 2024

N-Nitroso-varenicline

(2755871-02-2, NNV)

Varenicline

400

3

20 July 2022

Updated 16 October 2023

N-Nitroso-desvaleryl-valsartan /
(S)-2-(((2'-(1H-tetrazol-5-yl)- [1,1′-biphenyl]-4-yl) methyl)(nitroso)amino)- 3-methylbutanoic acid

(2254485-68-0)

Valsartan

NMI

29 July 2024

N-Nitroso-valsartan cyano-desvalerylmethylester /
(S)-Methyl 2-(((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)(nitroso) amino)-3-methylbutanoate

Valsartan

100

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

Vanzacaftor

1500

4

15 October 2024

N-Nitroso-vildagliptin

Vildagliptin

1500

5

24 August 2023

N-Nitroso vildagliptin amide impurity /
(S)-1-(2-(((1R, 3R, 5R, 7S)-3-hydroxyadamantan-1-yl)(nitroso)amino)acetyl)pyrrolidine-2-carboxamide

Vildagliptin

1500

5

15 October 2024

N-Nitroso-L-prolinamide /
(S)-1-nitrosopyrrolidine-2-carboxamide

(79108-51-3)

Vildagliptin

1500

4

4 February 2025

N-Nitroso-L-prolinenitrile /
(S)-1-nitrosopyrrolidine-2-carbonitrile

Vildagliptin

1500

4

4 February 2025

N-Nitroso-vortioxetine

Vortioxetine

400

3

24 August 2023

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

Zolmitriptan

18

1

4 February 2025