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Established acceptable intake for nitrosamines in medicines

Last updated

Below is a list of established AI limits for some nitrosamine impurities. These apply for all routes of administration.

Nitrosamine structures are available in the print version below.

Established AI limits for some other N-nitroso-structures. N-Nitroso-structures that include N-nitrosoguanidines, N-nitroso-indoles and N-nitrosoureas impurities are listed separately.

Established acceptable intake for nitrosamines in medicines

Nitrosamine

(CAS number, Abbreviation)

Source2

Nitrosamine structure

AI limit

(ng/day)1

CPCA

Potency category

First published

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

Acarbose
N-Nitroso-acarbose

1500

5

31 July 2025

1-Methyl-4-nitrosopiperazine

(16339-07-4, MeNP/MNP)

Sildenafil
1-Methyl-4-nitrosopiperazine (16339-07-4, MeNP/MNP)

400

3

3 November 2025

N-Nitroso-2,6-pipecoloxilidide /

desbutyl bupivacaine nitroso impurity

(3035512-94-5)

Bupivacaine
N-Nitroso-2 6-pipecoloxilidide

1500

4

3 November 2025

N-Nitroso-desmethyl-almotriptan

Almotriptan
N-Nitroso-desmethyl-almotriptan

18

1

3 November 2025

N-Nitroso-N-desethyl-amiodarone

(678982-38-2)

Amiodarone
N-Nitroso-N-desethyl-amiodarone

18

1

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

Berotralstat
N-Nitroso-berotralstat

100

2

3 November 2025

(2S,4R)-N-(6-Bromopyridin-2-yl)-4-fluoro-1-nitrosopyrrolidine-2-carboxamide

Danicopan
2S,4R-N-6-Bromopyridin-2-yl-4-fluoro-1-nitrosopyrrolidine-2-carboxamide

1500

4

3 November 2025

N-Nitroso‐N-desmethyl‐diltiazem

(3036581-85-5)

Diltiazem
N-Nitroso-desmethyl-diltiazem

100

 

3 November 2025

N-Nitroso-diethylamine

(55-18-5, NDEA)

Entacapone
N-Nitroso-diethylamine

26.5

 

3 November 2025

N-Nitroso-doravirine dimer

NDD

Doravirine
N-Nitroso-doravirine dimer

1500

 

3 November 2025

N-Nitroso-desmethyl-doxylamine /

N-methyl-N-(2-(1-phenyl-1-(pyridin-2-yl)ethoxy)ethyl)nitrous amide

Doxylamine
N-Nitroso-desmethyl-doxylamine

100

 

3 November 2025

N-Nitroso hydroxychloroquine EP Impurity C /

N-(4-((7-chloroquinolin-4-yl)amino)pentyl)-N-(2-hydroxyethyl)nitrous amide

Hydroxychloroquine
N-Nitroso hydroxychloroquine EP Impurity C

100

2

3 November 2025

N-Nitroso hydroxychloroquine EP Impurity D /

N-(4-((7-chloroquinolin-4-yl)amino)pentyl)-N-ethylnitrous amide

Hydroxychloroquine
N-Nitroso hydroxychloroquine EP Impurity D

18

1

3 November 2025

N-Nitroso-hydroxyzine Impurity A /

1-((4-chlorophenyl)(phenyl)methyl)-4-nitrosopiperazine

(2005-04-1)

Hydroxyzine
N-Nitroso-hydroxyzine Impurity A

400

3

3 November 2025

N-Nitroso-mirdametinib /

N-(2,3-dihydroxypropoxy)-3,4-difluoro-2-((2-fluoro-4-iodophenyl)(nitroso)amino)benzamide

Mirdametinib
N-Nitroso-mirdametinib

78000

 

3 November 2025

N-Nitroso-morpholine

(59-89-2, NMOR)

Molsidomine
N-Nitroso-morpholine

127.0

 

3 November 2025

N-Nitroso-nadolol

(134720-06-2)

Nadolol
N-Nitroso-nadolol

1500

5

3 November 2025

N-Nitroso-methylaminoantipyrine /
N-(1,5-dimethyl-3-oxo-2-phenylpyrazol-4-yl)-N-methylnitrous amide

(73829-38-6, NMAA)

Metamizole
N-Nitroso-methylaminoantipyrine

100

2

3 November 2025

N-Nitroso-methylethanolamine /
N-(2-hydroxyethyl)-N-methylnitrous amide

(26921-68-6, NMELA)

Nefopam
N-Nitroso-methylethanolamine

100

2

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

Nirogacestat
N-Nitroso-nirogacestat

1500

 

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

Nirogacestat
N-Nitroso-nirogacestat impurity 1

1500

5

3 November 2025

N-Nitroso-propafenone impurity B /
(R,E)-N-(3-(2-cinnamoylphenoxy)-2-hydroxypropyl)-N-propylnitrous amide

Propafenone
N-Nitroso-propafenone impurity B

100

2

3 November 2025

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

(NNTA)

Cobicistat
N-Nitroso-2,4-thiazole amine

18

1

3 November 2025

N-Nitroso venlafaxine EP Impurity D /
N-(2-(1-hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-methylnitrous amide

(2680662-11-5)

Venlafaxine
N-Nitroso venlafaxine EP Impurity D

18

1

3 November 2025

N-Nitroso venlafaxine EP Impurity H /
N-(2-(1-hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-(4-methoxyphenethyl)nitrous amide

Venlafaxine
N-Nitroso venlafaxine EP Impurity H

100

2

3 November 2025

N-Nitroso-dimethylamine

(62-75-9, NDMA)

Ranitidine
N-Nitroso-dimethylamine

96.0

 

15 September 2019 

 

N-Nitroso-dimethylamine

(62-75-9, NDMA)

Nizatidine
N-Nitroso-dimethylamine

96.0

 

15 September 2019 

N-Nitroso-dimethylamine

(62-75-9, NDMA)

Metformin
N-Nitroso-dimethylamine

96.0

 

15 September 2019 

N-Nitroso-benzathine /
N-nitroso-N,N'-dibenzylethanediamine /
N-benzyl-N-(2-(benzylamino)ethyl)nitrous amide

(NNB)

Benzathine
N-Nitroso-benzathine

18

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

Brinzolamide
N-Nitroso-brinzolamide

100

2

31 July 2025

N-Nitroso-carvedilol /
N-(3-((9H-carbazol-4-yl)oxy)-2-hydroxypropyl)-N-(2-(2-methoxyphenoxy)ethyl)nitrous amide

(2248746-67-8)

Carvedilol
N-Nitroso-carvedilol

400

3

31 July 2025

N-Nitroso-frovatriptan /
(6R)-6-[methyl(nitroso)amino]-6,7,8,9-tetrahydro-5H-carbazole-3-carboxamide

Frovatriptan
N-Nitroso-frovatriptan

400

3

31 July 2025

N-Nitroso-norfloxacin /
1-ethyl-6-fluoro-7-(4-nitrosopiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 

(74011-53-3) 

Norfloxacin
N-Nitroso-norfloxacin

NMI

 

31 July 2025

N-Nitroso-despropyl-ropinirole /
N-(2-(2-oxoindolin-4-yl)ethyl)-N-propylnitrous amide

Ropinirole
N-Nitroso-despropyl-ropinirole

18

1

31 July 2025

N-Nitroso-safinamide /
(2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methyl-nitrosoamino]propanamide

(2657645-00-4)

Safinamide
N-Nitroso-safinamide

400

3

31 July 2025

Default class specific threshold of toxicological concern TTC

-

18.0

Default limit

-

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

(N-M8)

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

18

1

29 July 2024

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

(20689-96-7, NBEA)

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

18

1

29 July 2024

1-Methyl-4-nitrosopiperazine

(16339-07-4, MeNP/MNP)

Rifampicin
1-Methyl-4-nitrosopiperazine

400

3

20 July 2022

Updated 24 August 2023

1-Nitroso-pyrrolopiperidine

-
1-Nitroso-pyrrolopiperidine

1500

4

24 August 2023

2-Nitroso-octahydrocyclopenta(c)pyrrole

(54786-86-6)

Gliclazide
2-Nitroso-octahydrocyclopenta(c)pyrrole

1700

24 August 2023

3-Amino-N-nitrosopiperidine

(2819242-71-0)

Alogliptin
3-Amino-N-nitrosopiperidine

400

3

16 October 2023

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

(64091-91-4, NNK)

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

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

100

2

20 July 2022

Updated 29 July 2024

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

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

400

3

24 August 2023

N-Nitroso-orphenadrine

(NMOA)

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

1500

4

24 August 2023

N-Methyl-N-nitrosophenethylamine

(13256-11-6, NMPEA)

-
N-Methyl-N-nitrosophenethylamine

8.0

5 January 2023

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

(55556-92-8, NTHP)

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

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

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
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

1500

4

16 October 2023

N-Nitroso-2,6-pipecoloxilidide /

desbutyl bupivacaine nitroso impurity

(3035512-94-5)

Ropivacaine
N-Nitroso-2,6-pipecoloxilidide

1500

4

24 August 2023

N-Nitroso-acebutolol

Acebutolol
N-Nitroso-acebutolol

1500

4

15 October 2024

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

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

100

2

29 July 2024

N-Nitroso-ambroxol

Ambroxol
N-Nitroso-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
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

1500

4

24 April 2024

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

(2221987-86-4)

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

400

3

31 January 2024

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

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

1500

4

29 July 2024

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

(NDAQ)

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

400

3

24 August 2023

N-Nitroso-atomoxetine

Atomoxetine
N-Nitroso-atomoxetine

100

24 August 2023

N-Nitroso-atenolol

(134720-04-0)

Atenolol
N-Nitroso-atenolol

1500

4

24 August 2023

N-Nitroso-azacyclonol

(1038-06-8)

Azacyclonol
N-Nitroso-azacyclonol

400

3

31 January 2024

N-Nitroso-desmethyl-azelastine

Azelastine
N-Nitroso-desmethyl-azelastine

100

2

31 January 2024

N-Nitroso-azithromycin

Azithromycin
N-Nitroso-azithromycin

NMI

24 August 2023

N-Nitroso-benazepril

Benazepril
N-Nitroso-benazepril

1500

5

24 August 2023

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

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

400

3

29 July 2024

N-Nitroso-betahistine

(32635-81-7)

Betahistine
N-Nitroso-betahistine

18

1

24 August 2023

N-Nitroso-betaxolol

Betaxolol
N-Nitroso-betaxolol

1500

4

31 January 2024

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

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

400

3

29 July 2024

N-Nitroso-bisoprolol

(2820170-76-9, NBP)

Bisoprolol
N-Nitroso-bisoprolol

1500

4

24 August 2023

N-Nitroso-bumetanide

(2490432-02-3, NNB)

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

NMI

24 August 2023

Updated 4 February 2025

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

(872826-80-7)

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

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
N-Nitroso-caspofungin

1500

4

29 July 2024

N-Nitroso-celiprolol

Celiprolol
N-Nitroso-celiprolol

1500

5

31 January 2024

N-Nitroso-cilazapril

(1053740-92-3)

Cilazapril
N-Nitroso-cilazapril

1500

5

24 August 2023

N-Nitroso-cinacalcet

Cinacalcet
N-Nitroso-cinacalcet

400

3

31 January 2024

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

(1698-25-5)

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

400

3

29 July 2024

N-Nitroso-ciprofloxacin

(864443-44-7)

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

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

400

3

24 April 2024

N-Nitroso-didecylamine

Colesevelam
N-Nitroso-didecylamine

100

2

4 February 2025

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

(77400-46-5, TMNO)

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

1500

4

24 April 2024

N-Nitroso-dabigatran etexilate

(NDAB)

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

1500

5

31 January 2024

N-Nitroso-N-deshydroxyethyl-dasatinib
N-(2-chloro-6-methylphenyl)-2-((2-methyl-6-(4-nitrosopiperazin-1-yl)pyrimidin-4-yl)amino)thiazole-5-carboxamide

(2135905-86-9)

Dasatinib
N-Nitroso-N-deshydroxyethyl-dasatinib

400

3

4 February 2025

N-Nitroso-desloratadine

(1246819-22-6)

Desloratadine
N-Nitroso-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
N-Nitroso-N-desmethyl 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
N-Nitroso-desmethyl-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
N-Nitroso-desmethyl-edoxaban

100

2

29 July 2024

N-Nitroso-desmethyl trimebutine

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

18

1

29 July 2024

N-Nitroso-desmethylazithromycin

Azithromycin
N-Nitroso-desmethylazithromycin

NMI

24 August 2023

N-Nitroso-desmethyl-chloropyramine

(N-DMCP)

Chloropyramine
N-Nitroso-desmethyl-chloropyramine

18

1

24 August 2023

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

Chlorphenamine
N-Nitroso-desmethyl-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
N-Nitroso-desmethyl-citalopram

100

31 January 2024

Updated 29 July 2024

N-Nitroso-desmethyl-tripelennamine

Tripelennamine
N-Nitroso-desmethyl-tripelennamine

18

1

24 August 2023

N-Nitroso-desvenlafaxine

Desvenlafaxine
N-Nitroso-desvenlafaxine

18

1

31 January 2024

N-Nitroso-diclofenac

(66505-80-4)

Diclofenac
N-Nitroso-diclofenac

78000

24 August 2023

Updated 15 October 2024

N-Nitroso-diethanolamine

(1116-54-7, NDELA)

-
N-Nitroso-diethanolamine

1900

5 January 2023

N-Nitroso-diethylamine

(55-18-5, NDEA)

-
N-Nitroso-diethylamine

26.5

15 September 2019

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

(601-77-4, DIPNA/NDIPA)

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

1500

5

15 September 2019

Updated 29 July 2024

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

(53609-64-6)

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

400

3

24 April 2024

N-Nitroso-dimethylamine

(62-75-9, NDMA)

-
N-Nitroso-dimethylamine

96.0

15 September 2019

N-Nitroso-di-n-butylamine

(924-16-3, NDBA)

-
N-Nitroso-di-n-butylamine

26.5

20 July 2022

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

(55855-43-1)

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

18

1

29 July 2024

N-Nitroso-diphenylamine

(86-30-6, NDPh)

-
N-Nitroso-diphenylamine

78000

5 January 2023

N-Nitroso-dipropylamine

(621-64-7, NDPA)

-
N-Nitroso-dipropylamine

26.5

20 July 2022

N-Nitroso-dorzolamide

Dorzolamide
N-Nitroso-dorzolamide

1500

31 January 2024

N-Nitroso-duloxetine

(2680527-91-5, NDLX)

Duloxetine
N-Nitroso-duloxetine

100

20 July 2022

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

Eletriptan
N-Nitroso-desmethyl-eletriptan

1500

4

4 February 2025

N-Nitroso-enalapril

Enalapril
N-Nitroso-enalapril

1500

5

24 August 2023

N-Nitroso-epinephrine / N-nitroso-adrenaline

Epinephrine / Adrenaline
N-Nitroso-epinephrine / N-nitroso-adrenaline

100

2

4 February 2025

N-Nitroso-esmolol

Esmolol
N-Nitroso-esmolol

1500

4

31 January 2024

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

(16339-04-1, EIPNA/NEIPA)

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

400

3

15 September 2019

Updated 29 July 2024

N-Nitroso-felodipine

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

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

1500

4

24 April 2024

N-Nitrosofluoxetine

(150494-06-7)

Fluoxetine
N-Nitrosofluoxetine

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
N-Nitroso-folic acid

1500

4

24 August 2023

Updated 29 July 2024

N-Nitroso-calcium folinate

Calcium folinate / Calcium levofolinate
N-Nitroso-calcium folinate

NMI

31 January 2024

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

(2708280-93-5)

Furosemide
N-Nitroso-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
N-nitroso-desmethyl-galantamine

18

1

4 February 2025

N-Nitroso-hydrochlorothiazide

(63779-86-2, NHCTZ)

Hydrochlorothiazide
N-Nitroso-hydrochlorothiazide

NMI

24 August 2023

N-Nitroso imatinib

Imatinib
N-Nitroso imatinib

1500

5

31 January 2024

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

(85440-79-5)

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

1500

5

31 January 2024

N-Nitroso-ethylenediamine-triacetic acid

(862542-34-5)

Isosorbide mononitrate
N-Nitroso-ethylenediamine-triacetic acid

1500

4

31 January 2024

N-Nitroso-iminodiacetic acid

(25081-31-6)

Isosorbide mononitrate
N-Nitroso-iminodiacetic acid (25081-31-6)

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

1500

5

4 February 2025

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

(86144-35-6)

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

1500

5

24 August 2023

N-Nitroso-labetalol

(2820170-74-7)

Labetalol
N-Nitroso-labetalol

1500

4

24 August 2023

N-Nitroso-landiolol

Landiolol
N-Nitroso-landiolol

400

3

24 August 2023

N-Nitroso-leniolisib

Leniolisib
N-Nitroso-leniolisib

1500

5

31 January 2024

N-Nitroso-levofloxacin

(1152314-62-9)

Levofloxacin
N-Nitroso-levofloxacin

1500

4

24 August 2023

N-Nitroso-desethyllidocaine

Lidocaine / Lignocaine
N-Nitroso-desethyllidocaine

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
N-Nitroso-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
N-Nitroso-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
N-Nitroso-masitinib

400

3

24 April 2024

N-Nitroso-mefenamic acid

(2114-63-8)

Mefenamic acid
N-Nitroso-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)
N-Nitroso-iminodibenzyl

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
N-Nitroso-meropenem

1500

4

24 April 2024

N-Nitroso-methylphenidate

(55557-03-4, NMPH)

Methylphenidate
N-Nitroso-methylphenidate

1300

20 July 2022

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

Methylphenidate
N-Nitroso-ritalinic acid

1500

4

24 April 2024

N-Nitroso-metoprolol

(138768-62-4)

Metoprolol
N-Nitroso-metoprolol

1500

4

24 August 2023

N-Nitroso-mirabegron

Mirabegron
N-Nitroso-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
N-(2-Hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide

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
N-(4-Aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide

400

3

29 July 2024

N-Nitroso-mirtazapine

Mirtazapine
N-Nitroso-mirtazapine

400

3

31 January 2024

N-Nitroso-morpholine

(59-89-2, NMOR)

-
N-Nitroso-morpholine

127.0

20 July 2022

N-Nitroso-moxifloxacin

Moxifloxacin
N-Nitroso-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
N-Nitroso-nor-oxycodone

1500

4

4 February 2025

N-Nitroso-nebivolol

(1391051-68-5, NNEB)

Nebivolol
N-Nitroso-nebivolol

NMI

 

24 August 2023

Updated 31 July 2025

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

(37620-20-5, NAB)

Nicotine
N-Nitroso-anabasine

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
N-Nitroso-anatabine

1500

4

4 February 2025

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

(16543-55-8, NNN)

Nicotine
N-Nitroso-nornicotine

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
N-Nitroso-nilotinib

1500

5

4 February 2025

N-Nitroso desmethyl nintedanib

Nintedanib
N-Nitroso desmethyl 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
N-Nitroso-posaconazole Impurity 1

400

3

29 July 2024

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

Propafenone
N-Nitroso-propafenon

100

2

15 October 2024

N-Nitroso-N-ethyl-valaciclovir

Valaciclovir
N-Nitroso-N-ethyl-valaciclovir

400

3

24 August 2023

N-Nitroso-N-methyl-valaciclovir

Valaciclovir
N-Nitroso-N-methyl-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
N-Nitroso-vibegron

1500

5

29 July 2024

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

(61445-55-4, NMBA)

-
N-Nitroso-N-methyl-4-aminobutyric acid

1500

4

15 September 2019

Updated 29 July 2024

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

(614-00-6, NMPA)

-
N-Nitroso-N-methylaniline

100

2

31 January 2024

N-Nitroso-nortriptyline

(55855-42-0, NNORT)

Amitriptyline, Nortriptyline
N-Nitroso-nortriptyline

18

1

20 July 2022

Updated 15 October 2024

4-Nitroso-methyl piperazine-1-carboxylate

(N-nitroso PMEC)

Omecamtiv mecarbil
4-Nitroso-methyl piperazine-1-carboxylate

400

3

29 July 2024

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

(48121-20-6)

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

400

3

29 July 2024

N-Nitroso-paroxetine

(2361294-43-9)

Paroxetine
N-Nitroso-paroxetine

1300

5 January 2023

N-Nitroso-p-chloro-benzylamino-pyridine

(N-CBAP)

Chloropyramine
N-Nitroso-p-chloro-benzylamino-pyridine

100

2

24 August 2023

N-Nitroso-perindopril

Perindopril
N-Nitroso-perindopril

1500

5

24 August 2023

N-Nitroso-phenylephrine

(78658-64-7)

Phenylephrine
N-Nitroso-phenylephrine

100

2

24 August 2023

N-Nitroso-piperazine

(5632-47-3, NPZ)

-
N-Nitroso-piperazine

400

3

24 August 2023

N-Nitrosopiperidine

(100-75-4)

-
N-Nitrosopiperidine

1300

20 July 2022

N-Nitroso-pramipexole

Pramipexole
N-Nitroso-pramipexole

400

3

24 August 2023

N-Nitroso-propranolol

(84418-35-9)

Propranolol
N-Nitroso-propranolol

1500

4

24 August 2023

N-Nitroso-pseudoephedrine

(1850-88-0)

Pseudoephedrine
N-Nitroso-pseudoephedrine

1500

4

24 August 2023

N-Nitroso-pyrrolidine

(930-55-2, NPYR)

-
N-Nitroso-pyrrolidine

1700

5 January 2023

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

(73486-81-4)

Quetiapine
N-Nitroso quetiapine HEEP impurity

1500

31 January 2024

N-Nitroso-quinapril

Quinapril
N-Nitroso-quinapril

NMI

24 August 2023

N-Nitroso-ramipril

Ramipril
N-Nitroso-ramipril

1500

5

24 August 2023

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

Ranolazine
N-nitroso ranolazine impurity 1

400

3

31 January 2024

N-Nitrosorasagiline

(2470278-90-9) 

Rasagiline
N-Nitrosorasagiline

100

2

20 July 2022

Updated 24 August 2023

N-Nitroso-reboxetine

Reboxetine
N-Nitroso-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
N-Nitroso-ribociclib impurity 1

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
N-Nitroso-desformyl-riociguat

100

2

29 July 2024

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

(NNTA)

Ritonavir
N-Nitroso-2,4-thiazole amine

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
N-Nitroso-rivaroxaban open-ring acid

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
N-Nitroso-rivaroxaban amide

1500

4

31 January 2024

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

Rivaroxaban
Rivaroxaban Nitroso Impurity 1

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
Rivaroxaban Nitroso Impurity 2

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
Rivaroxaban Nitroso Impurity 5

1500

4

29 July 2024

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

Rivastigmine
N-Nitroso-desmethyl-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
N-Nitroso-N-desmethyl-rizatriptan

18

1

15 October 2024

N-Nitroso-salbutamol

(2919946-71-5)

Salbutamol
N-Nitroso-salbutamol

1500

5

24 August 2023

N-Nitroso-sertraline

Sertraline
N-Nitroso-sertraline

100

2

24 August 2023

Updated 16 October 2023

Updated 15 October 2024

N-Nitroso-desmethyl-sildenafil

Sildenafil
N-Nitroso-desmethyl-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
N-Nitroso-silodosin

1500

4

24 April 2024

N-Nitroso-sotalol

(134720-07-3)

Sotalol
N-Nitroso-sotalol

1500

4

24 August 2023

N-Nitroso-desmethyl sumatriptan

Sumatriptan
N-Nitroso-desmethyl 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
N-Nitroso-desmethyl-tamoxifen

18

1

24 April 2024

N-Nitroso-tamsulosin

(2892260-31-8)

Tamsulosin
N-Nitroso-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
N-Nitroso terazosin impurity C / N-nitroso 6,7-dimethoxy-2-(1-piperazinyl)-4-quinazolinamine

400

3

24 April 2024

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

(2470438-57-2)

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

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

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

18

1

31 January 2024

N-Nitroso-tetracaine

Tetracaine
N-Nitroso-tetracaine

400

3

31 January 2024

N‐Nitroso‐ticagrelor

(2476859-55-7)

Ticagrelor
N‐Nitroso‐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
N-Nitroso-tigecycline

NMI

29 July 2024

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

Tramadol
N-Nitroso-desmethyl-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
N-Nitroso-trandolapril

1500

5

29 July 2024

N-Nitroso-trimetazidine

(92432-50-3, NTMZ)

Trimetazidine
N-Nitroso-trimetazidine

400

3

24 August 2023

N-Nitroso-urapidil

Urapidil
N-Nitroso-urapidil

1500

4

31 January 2024

N-Nitroso-varenicline

(2755871-02-2, NNV)

Varenicline
N-Nitroso-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
N-Nitroso-desvaleryl-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
N-Nitroso-valsartan cyano-desvalerylmethylester

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
N-Nitroso-vanzacaftor

1500

4

15 October 2024

N-Nitroso-vildagliptin

Vildagliptin
N-Nitroso-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
N-Nitroso vildagliptin amide impurity

1500

5

15 October 2024

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

(79108-51-3)

Vildagliptin
N-Nitroso-L-prolinamide

1500

4

4 February 2025

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

Vildagliptin
N-Nitroso-L-prolinenitrile

1500

4

4 February 2025

N-Nitroso-vortioxetine

Vortioxetine
N-Nitroso-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
N‐Nitroso‐desmethyl‐zolmitriptan

18

1

4 February 2025

2-(N-Nitrosomethylamino)-N-[6-(trifluoromethoxy)-1,3-benzothiazol-2-yl]acetamide 
(NNT)

Troriluzole
2-N-Nitrosomethylamino-N-6-trifluoromethoxy-1,3-benzothiazol-2-yl acetamide

100

2

30 April 2025

N-Nitroso-sarcosine /
2-[methyl(nitroso)amino]acetic acid 
(13256-22-9, NSAR)

Troriluzole
N-Nitroso-sarcosine

1500

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

(155386-25-7)

Vancomycin
N-Nitroso-vancomycin

1500

4

30 April 2025

N-Nitroso-N-desmethyl-mianserin /
2-nitroso-1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine

Mianserin
N-Nitroso-N-desmethyl-mianserin

400

3

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

Lercanidipine
N-Nitroso-desmethyl-lercanidipine

100

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

Lercanidipine
N-Nitroso-desmethyl-lercanidipine impurity D

100

2

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

Dasatinib
N-Nitroso-dasatinib

1500

5

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

Dalbavancin
N-Nitroso-dalbavancin

1500

4

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

Cabergoline
N-Nitroso-desmethyl-cabergoline

18

1

30 April 2025

CPCA: Carcinogenic Potency Categorisation Approach
NMI: Non mutagenic impurity should be controlled to ICH Q3A and ICH Q3B guideline limits  

  1. 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.
  2. 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.

Nitrosamine structures are available print version

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