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EMA 亚硝胺指南与技术附件·· 2 天前精选AI 评分74

EMA 更新 N-亚硝胺可接受摄入量附录 Rev.14（EMA/CHMP/219920/2026/Rev. 14）

EMA 亚硝胺：Appendix 1: Acceptable intakes established for N-nitrosamines

AI 导读

EMA 非临床工作组（NcWP）更新 N-亚硝胺可接受摄入量（AI）附录，本次为 Rev.14，工作簿版本日期 2026-10-01，官方目录更新日 2026-10-13。

推荐理由

工作簿按 CPCA 分类列出各 N-亚硝胺的可接受摄入量及其来源活性成分与发布日期，可对照 Rev.14 的新增条目。

正文 · 原文

EMA 亚硝胺技术文件：Appendix 1: Acceptable intakes established for N-nitrosamines

官方目录首次发布：2023-07-07。本次目录更新：2026-10-13。

目录文件编号：EMA/42261/2025 Rev.14。

本文排序日期采用官方目录更新日；文件版本日与实施日分别保留，不以采集日替代。

工作簿版本日期：2026-10-01；工作簿文件编号：EMA/CHMP/219920/2026/Rev. 14。两者按文件原文保留。

官方工作簿表格版；保留两张工作表的文字、数据和化学结构图。原始排版及标色请查看官方 XLSX。

N-nitrosamines

2026-10-01

EMA/CHMP/219920/2026/Rev. 14

Non-clincal Working Party (NcWP)

Acceptable intakes (AIs) established for N-nitrosamines

Appendix 1 to Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for

the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us
Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000
An agency of the European Union

The below acceptable intake levels (AIs) have been established by the Non-clinical Working Party (NcWP) and, where applicable, determined using the Carcinogenic Potency Categorization Approach (CPCA).
These limits are applicable only if a FP contains a single N-nitrosamine.
The source refers to potential presence of nitrosamine impurities with structures derived from active substances or their related impurities. This does not mean that the impurity will be found in all products or pharmaceutical forms containing the named API. Please refer to Q&A on the risk factors for the presence of nitrosamines for further details.

The below acceptable intake levels (AIs) have been established by the Non-clinical Working Party (NcWP) and, where applicable, determined using the Carcinogenic Potency Categorization Approach (CPCA).
These limits are applicable only if a FP contains a single N-nitrosamine.
The source refers to potential presence of nitrosamine impurities with structures derived from active substances or their related impurities. This does not mean that the impurity will be found in all products or pharmaceutical forms containing the named API.
Please refer to Q&A on the risk factors for the presence of nitrosamines for further details.

StructureNameIUPAC nameSMILESCAS RNSynonym/ AcronymSourceCPCA CategoryAI (ng/day)NotePublication date
N-nitrosamines A21 化学结构1-cyclopropylmethyl-4-nitrosopiperazine1-(cyclopropylmethyl)-4-nitrosopiperazineC1CC1CN2CCN(CC2)N=O57184-25-5Mitapivat34002023-07-01
N-nitrosamines A22 化学结构1-diphenylmethyl-4-nitrosopiperazine1-benzhydryl-4-nitrosopiperazineC1CN(CCN1C(C2=CC=CC=C2)C3=CC=CC=C3)N=O1698-25-5Cinnarizine34002024-07-01
N-nitrosamines A23 化学结构1-methyl-4-nitrosopiperazine1-methyl-4-nitrosopiperazineCN1CCN(CC1)N=O16339-07-4MeNPRifampicin34002023-07-01
N-nitrosamines A24 化学结构1-Nitroso-3-piperidinamine1-nitrosopiperidin-3-amineC1CC(CN(C1)N=O)N2819242-71-0Alogliptin34002023-10-01
N-nitrosamines A25 化学结构1-nitroso-pyrrolopiperidine1-nitroso-2,3,4,4a,5,6,7,7a-octahydropyrrolo[3,4-b]pyridineC1CC2CNCC2N(C1)N=ONAMoxifloxacin415002023-07-01
N-nitrosamines A26 化学结构2-(4-nitrosopiperazin-1-yl)ethanol2-(4-nitrosopiperazin-1-yl)ethanolC1CN(CCN1CCO)N=O48121-20-6Opipramol34002024-05-01
N-nitrosamines A27 化学结构2,2,5-trimethyl-3-nitroso-1,3-oxazolidine2,2,5-trimethyl-3-nitroso-1,3-oxazolidineCC1CN(C(O1)(C)C)N=O77400-46-5TMNOCyanocobalamine415002024-02-15
N-nitrosamines A28 化学结构2-nitroso-octahydrocyclopenta(c)pyrrole2-nitroso-3,3a,4,5,6,6a-hexahydro-1H-cyclopenta[c]pyrroleC1CC2CN(CC2C1)N=O54786-86-6Gliclazide1700Limit derived using structure-activity- relationship (SAR)/read-across approach using the TD50 of NPYR as point of departure.2023-07-01
N-nitrosamines A29 化学结构3-[[ethyl(nitroso)amino]methyl] benzenesulfonic acid3-[[ethyl(nitroso)amino]methyl] benzenesulfonic acidCCN(CC1=CC(=CC=C1)S(=O)(=O)O)N=ONABrilliant blue FCF1182024-05-01
N-nitrosamines A30 化学结构4-(methylnitrosoamino)-1-(3-pyridyl)-1-butanoneN-methyl-N-(4-oxo-4-pyridin-3-ylbutyl)nitrous amideCN(CCCC(=O)C1=CN=CC=C1)N=O64091-91-4NNK100Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from the Lhasa Carcinogenicity Database (LCDB).2023-07-01
N-nitrosamines A31 化学结构6,7-dichloro-4-nitroso-1,3,4,5-tetrahydro-2H-benzo[e][1,4] diazepin-2-one6,7-dichloro-4-nitroso-1,3,4,5-tetrahydro-2H-benzo[e][1,4] diazepin-2-oneO=C2CN(N=O)Cc1c(Cl)c(Cl)ccc1N2NAAnagrelide210001 October 2026 (new)
N-nitrosamines A32 化学结构6-nitro-N-nitrosoadrenalineN-[2-(4,5-dihydroxy-2-nitrophenyl)-2-hydroxyethyl]-N-methylnitrous amideCN(CC(C1=CC(=C(C=C1[N+](=O)[O-])O)O)O)N=ONAAdrenaline21002026-03-01
N-nitrosamines A33 化学结构Aripiprazole Nitroso Impurity1-(2,3-dichlorophenyl)-4-nitrosopiperazineC1CN(CCN1C2=C(C(=CC=C2)Cl)Cl)N=O2989508-28-1Aripiprazole34002024-01-15
N-nitrosamines A34 化学结构Ethyl N-(2,3-dichloro-6-nitrobenzyl)-N-nitrosoglycinateEthyl N-(2,3-dichloro-6-nitrobenzyl)-N-nitrosoglycinateClC1=CC=C([N+]([O-])=O)C(CN(N=O)CC(OCC)=O)=C1ClNAAnagrelide210001 October 2026 (new)
N-nitrosamines A35 化学结构Ethyl N-(6-amino-2,3-dichlorobenzyl)-N-nitrosoglycinateEthyl N-(6-amino-2,3-dichlorobenzyl)-N-nitrosoglycinateNC1=CC=C(Cl)C(Cl)=C1CN(N=O)CC(OCC)=ONAAnagrelide210001 October 2026 (new)
N-nitrosamines A36 化学结构Indapamide EP impurity A2-methyl-1-nitroso-2,3-dihydroindoleCC1CC2=CC=CC=C2N1N=O85440-79-5Indapamide515002023-11-15
N-nitrosamines A37 化学结构Methyl 2-(methylnitrosoamino) benzoatemethyl 2-[methyl(nitroso)amino]benzoateCN(C1=CC=CC=C1C(=O)OC)N=O68061-82-5NO-MMA21002025-12-01
N-nitrosamines A38 化学结构methyl 4-nitrosopiperazine-1-carboxylatemethyl 4-nitrosopiperazine-1-carboxylateCOC(=O)N1CCN(CC1)N=ONAN-nitroso-PMECOmecamtiv mecarbil34002024-05-01
N-nitrosamines A39 化学结构Mirabegron Nitroso Impurity 12N-(2-hydroxy-2-phenylethyl)-N-[2-(4-nitrophenyl)ethyl]nitrous amideC1=CC=C(C=C1)C(CN(CCC2=CC=C(C=C2)[N+](=O)[O-])N=O)ONAMBL-2-NOMirabegron34002024-05-01
N-nitrosamines A40 化学结构N,N'-dimethylethylenedinitrosamineN-methyl-N-[2-[methyl(nitroso)amino]ethyl]nitrous amideCN(CCN(C)N=O)N=O13256-12-7NDMEA, NNDMA1182026-03-01
N-nitrosamines A41 化学结构N,N-dinitroso-desmethyl-sumatriptanN-methyl-1-(3-(2-(methyl(nitroso)amino)ethyl)-1-nitroso-1H-indol-5-yl)methanesulfonamideCNS(=O)(=O)CC1=CC2=C(C=C1)N(C=C2CCN(C)N=O)N=OSumatriptan11801 October 2026 (new)
N-nitrosamines A42 化学结构Nitroso-STG-197-nitroso-3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazineC1CN2C(=NN=C2C(F)(F)F)CN1N=O2892260-32-9NTTPSitagliptin2100CPCA derived AI as substance tested positive in in vivo mutagenicity study2022-05-01
N-nitrosamines A43 化学结构N-Nitroso Benzydamine EP Impurity A3-(dimethylamino)propyl 2-[benzyl(nitroso)amino]benzoateCN(C)CCCOC(=O)C1=CC=CC=C1NCC2=CC=CC=C2NA3DPNBenzydamine1500Limit based on negative bacterial reverse mutation test2024-07-01
N-nitrosamines A44 化学结构N-Nitroso derivative of rotigotine impurity BN-(5-hydroxy-1,2,3,4-tetrahydronaphthalen-2-yl)-N-propylnitrous amideC1=CC(=C2C(=C1)CC(CC2)N(CCC)N=O)ONARotigotine34002023-10-01
N-nitrosamines A45 化学结构N-nitroso derivative of rotigotine impurity CN-[5-hydroxy-1,2,3,4-tetrahydronaphthalen-2-yl]-N-(2-thiophen-2-ylethyl)nitrous amideC1CC=3C(CC1N(CCC=2SC=CC=2)N=O)=CC=CC=3ONARotigotine415002023-10-01
N-nitrosamines A46 化学结构N-Nitroso Ranolazine USP Related Compound CN-(2,6-dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamideCC1=C(C(=CC=C1)C)NC(=O)CN2CCN(CC2)N=ONARanolazine34002023-07-01
N-nitrosamines A47 化学结构N-nitroso-1,2,3,6-tetrahydropyridine1-nitroso-3,6-dihydro-2H-pyridineC1CN(CC=C1)N=O55556-92-8NTHP37Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from the Lhasa Carcinogenicity Database (LCDB).2022-05-01
N-nitrosamines A48 化学结构N-nitroso-2,4-thiazoleamineN-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amideCC(C)C1=NC(=CS1)CN(C)N=ONANNTARitonavir/ Cobicistat118CPCA derived AI as substance tested positive in in vivo mutagenicity study2024-09-01
N-nitrosamines A49 化学结构N-nitroso-2,6-pipecoloxilidideN-(2,6-dimethylphenyl)-1-nitrosopiperidine-2-carboxamideC1=CC=C(C(=C1C)NC(C2CCCCN2N=O)=O)CNARopivacaine415002023-07-01
N-nitrosamines A50 化学结构N-nitroso-4-phenylpiperazine1-nitroso-4-phenylpiperazineC1CN(CCN1C2=CC=CC=C2)N=O14340-33-1Levodropropizine34002025-12-01
N-nitrosamines A51 化学结构N-nitroso-abacavirN-[2-amino-9-[4-(hydroxymethyl)cyclopent-2-en-1-yl]purin-6-yl]-N-cyclopropylnitrous amideC1CC1N(C2=NC(=NC3=C2N=CN3C/4CC(\C=C/4)CO)N)N=ONAAbacavir515002026-06-01
N-nitrosamines A52 化学结构N-nitroso-acarboseN-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-glucopyranoseC[C@H]1O[C@@H]([C@@H]([C@H]([C@@H]1N(N=O)[C@@H]/2[C@@H]([C@H]([C@@H](\C(CO)=C/2)O)O)O)O)O)O[C@H]3[C@@H]([C@H]([C@H](O[C@@H]3CO)O[C@H]4[C@@H]([C@H](C(OC4CO)O)O)O)O)ONAAcarbose515002025-05-15
N-nitrosamines A53 化学结构N-nitroso-acebutololN-(3-acetyl-4-(2-hydroxy-3-(isopropyl(nitroso)amino)propoxy)phenyl)butyramideC1=C(C=CC(=C1C(C)=O)OCC(CN(C(C)C)N=O)O[H])N(C(CCC)=O)[H]NAAcebutolol415002024-09-01
N-nitrosamines A54 化学结构N-nitroso-adrenalineN-[(2R)-2-(3,4-dihydroxyphenyl)-2-hydroxyethyl]-N-methylnitrous amideCN(C[C@@H](C1=CC(=C(C=C1)O)O)O)N=O3006789-99-4N-nitroso-epinephrineAdrenaline21002026-03-01
N-nitrosamines A55 化学结构N-nitroso-alprazolam EP Impurity HN,N-bis((4-(2-benzoyl-4-chlorophenyl)-5-methyl-4H-1,2,4-triazol-3-yl)methyl)nitrous amideCC=1N(C(=NN=1)CN(CC=4N(C3=C(C(=O)C=2C=CC=CC=2)C=C(Cl)C=C3)C(=NN=4)C)N=O)C6=C(C(=O)C=5C=CC=CC=5)C=C(Cl)C=C6NAAlprazolam1500Limit based on negative bacterial reverse mutation test2026-06-01
N-nitrosamines A56 化学结构N-nitroso-ambroxolN-[(2-amino-3,5-dibromophenyl)methyl]-N-[4-hydroxycyclohexyl]nitrous amideC1CC(CCC1N(CC2=C(C(=CC(=C2)Br)Br)N)N=O)ONAAmbroxol1500Limit based on negative bacterial reverse mutation test2023-07-01
N-nitrosamines A57 化学结构N-nitroso-anabasine3-(1-nitrosopiperidin-2-yl)pyridineC1CCN(C(C1)C2=CN=CC=C2)N=O37620-20-5NABNicotine415002024-12-01
N-nitrosamines A58 化学结构N-nitroso-anatabine3-[1-nitroso-3,6-dihydro-2H-pyridin-2-yl] pyridineO=NN1CC=CCC1C=2C=NC=CC271267-22-6NATNicotine415002024-12-01
N-nitrosamines A59 化学结构N-nitroso-apixaban impurity B5-[4-[3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-4,5-dihydropyrazolo[3,4-c]pyridin-6-yl]-N-nitrosoanilino]pentanoic acidCOC1=CC=C(C=C1)N2C3=C(CCN(C3=O)C4=CC=C(C=C4)N(CCCCC(=O)O)N=O)C(=N2)C(=O)NNAApixaban415002024-02-15
N-nitrosamines A60 化学结构N-nitroso-articainemethyl 4-methyl-3-(2-(nitroso(propyl)amino)propanamido)thiophene-2-carboxylateCCCN(C(C)C(=O)NC1=C(SC=C1C)C(=O)OC)N=ONAArticaine415002024-05-01
N-nitrosamines A61 化学结构N-nitroso-aryl piperazine11-(4-Nitrosopiperazin-1-yl)dibenzo[b,f][1,4]thiazepineC1CN(CCN1N=O)C/3=N\C2=CC=CC=C2SC4=CC=CC=C/34NAN-nitroso-desalkyl-quetiapine/ NDAQQuetiapine34002023-07-01
N-nitrosamines A62 化学结构N-nitroso-atenolol2-[4-[2-hydroxy-3-[nitroso(propan-2-yl)amino]propoxy]phenyl]acetamideCC(C)N(CC(COC1=CC=C(C=C1)CC(=O)N)O)N=O134720-04-0Atenolol41500CPCA derived AI as substance tested positive in in vivo mutagenicity study2023-07-01
N-nitrosamines A63 化学结构N-nitroso-atomoxetineN-methyl-N-[(3R)-3-(2-methylphenoxy)-3-phenylpropyl]nitrous amideCC1=CC=CC=C1O[C@@H](C2=CC=CC=C2)CCN(N=O)CNAAtomoxetine100Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure as substance tested positive in in vivo mutagenicity study2023-07-01
N-nitrosamines A64 化学结构N-nitroso-azacyclonolN-nitroso-diphenyl(piperidin-4-yl)methanolOC(C1=CC=CC=C1)(C2CCN(N=O)CC2)C3=CC=CC=C31038-06-8Azacyclonol34002024-01-15
N-nitrosamines A65 化学结构N-nitroso-azaerythromycin(2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-11-(((2S, 3R, 4S, 6R)-4-(dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2-ethyl-3, 4, 10-trihydroxy-13-(((2R, 4R, 5S, 6S)-5-hydroxy-4-methoxy-4, 6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-3, 5, 8, 10, 12, 14-hexamethyl-6-nitroso-1-oxa-6-azacyclopentadecan-15-oneO=NN1C[C@H](C)C[C@@](C)(O)[C@H](O[C@@H]2O[C@H](C)C[C@@H]([C@H]2O)N(C)C)[C@@H](C)[C@@H]([C@H](C(=O)O[C@@H]([C@@]([C@@H]([C@H]1C)O)(C)O)CC)C)O[C@@H]1O[C@@H](C)[C@@H]([C@](C1)(C)OC)ONAAzithromycinNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A66 化学结构N-nitroso-benazepril2-((S)-3-(((S)-1-Ethoxy-1-oxo-4-phenylbutan-2-yl)(nitroso)amino)-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetic acidCCOC(=O)[C@H](CCC1=CC=CC=C1)N([C@H]3CCC2=CC=CC=C2N(C3=O)CC(=O)O)N=ONABenazepril515002023-07-01
N-nitrosamines A67 化学结构N-nitroso-benzathineN-benzyl-N-(2-(benzylamino)ethyl)nitrous amideO=NN(CC1=CC=CC=C1)CCNCC2=CC=CC=C2NANNBBenzathine1182025-05-15
N-nitrosamines A68 化学结构N-nitroso-berotralstat(R)-1-(3-(Aminomethyl)phenyl)-N-(5-((3-cyanophenyl)((cyclopropylmethyl) (nitroso)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamideNCC1=CC(=CC=C1)N2N=C(C=C2C(=O)NC3=CC(=CC=C3F)[C@H](N(CC4CC4)N=O)C5=CC=CC(=C5)C#N)C(F)(F)FNABerotralstat1500Limit based on negative bacterial reverse mutation test2025-08-01
N-nitrosamines A69 化学结构N-nitroso-betahistineN-methyl-N-(2-pyridin-2-ylethyl)nitrous amideCN(CCC1=CC=CC=N1)N=O32635-81-7Betahistine118CPCA derived AI as substance tested positive in in vivo mutagenicity study2023-07-01
N-nitrosamines A70 化学结构N-nitroso-betaxololN-(3-(4-(2-(cyclopropylmethoxy)ethyl)phenoxy)-2-hydroxypropyl)-N-isopropylnitrous amideCC(C)N(CC(COC1=CC=C(C=C1)CCOCC2CC2)O)N=ONABetaxolol415002024-01-15
N-nitrosamines A71 化学结构N-nitroso-bilastine impurity 21-(2-Ethoxyethyl)-2-(1-nitrosopiperidin-4-yl)-1H-benzo[d]imidazoleO=NN(CC1)CCC1C2=NC3=CC=CC=C3N2CCOCCNABilastine34002024-07-01
N-nitrosamines A72 化学结构N-nitroso-bisoprololN-[2-hydroxy-3-[4-(2-propan-2-yloxyethoxymethyl)phenoxy]propyl]-N-propan-2-ylnitrous amideCC(C)N(CC(COC1=CC=C(C=C1)COCCOC(C)C)O)N=O2820170-76-9NBPBisoprolol415002023-07-01
N-nitrosamines A73 化学结构N-nitroso-brensocatib(S)-N-((S)-1-cyano-2-(4-(3-methyl-2-oxo-2,3-dihydrobenzo[d]oxazol-5-yl)phenyl)ethyl)-4-nitroso-1,4-oxazepane-2-carboxamideCN1C(=O)OC2=C1C=C(C=C2)C3=CC=C(C=C3)C[C@@H](C#N)NC(=O)[C@@H]4CN(CCCO4)N=ONABrensocatib1500Limit based on negative bacterial reverse mutation test2026-03-01
N-nitrosamines A74 化学结构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-dioxideCCN(N=O)C1CN(CCCOC)S(=O)(=O)C=2SC(S(N)(=O)=O)=CC1=2NABrinzolamide21002025-05-15
N-nitrosamines A75 化学结构N-nitroso-bumetanide3-[butyl(nitroso)amino]-4-phenoxy-5-sulfamoylbenzoic acidCCCCN(C1=C(C(=CC(=C1)C(=O)O)S(=O)(=O)N)OC2=CC=CC=C2)N=O2490432-02-3NNBBumetanide1500Limit based on negative bacterial reverse mutation test2023-07-01
N-nitrosamines A76 化学结构N-nitroso-bupropionN-tert-butyl-N-[1-(3-chlorophenyl)-1-oxopropan-2-yl]nitrous amideCC(N(N=O)C(C)(C)C)C(C1=CC=CC(Cl)=C1)=O2763780-10-3BupropionNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A77 化学结构N-nitroso-buspirone Impurity 12-(4-nitrosopiperazine-1-yl)-pyrimidineC1=NC(=NC=C1)N2CCN(CC2)N=O872826-80-7Buspirone34002024-09-01
N-nitrosamines A78 化学结构N-nitroso-calcium folinateN-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl](nitroso)amino]benzoyl]-L-glutamic acidC1C(N(C2=C(N1)N=C(NC2=O)N)C=O)CN(C3=CC=C(C=C3)C(=O)N[C@H](CCC(=O)[O-])C(=O)[O-])N=ONAN-nitroso-leucovorin-2Calcium folinate/ Calcium levofolinateNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-11-15
N-nitrosamines A79 化学结构N-nitrosamines A79 化学结构N-nitroso-carvedilolN-(3-((9H-Carbazol-4-yl)oxy)-2-hydroxypropyl)-N-(2-(2-methoxyphenoxy)ethyl)nitrous amideCOC=1C=CC=CC=1OCCN(N=O)CC(O)COC2=CC=CC4=C2C=3C=CC=CC=3N42248746-67-8Carvedilol34002025-05-15
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-dimethyltetradecanamideC(CCCCCCCC(=O)N[C@@H]1C(NC(C(N4[C@H](C(NC(C(N[C@@H](C(N2[C@H](C(N[C@@H]([C@@H](CC1)O)N(CCN)N=O)=O)[C@H](CC2)O)=O)[C@H](CCN)O)=O)[C@@H]([C@H](C3=CC=C(C=C3)O)O)O)=O)C[C@H](C4)O)=O)[C@H](C)O)=O)[C@H](C[C@H](CC)C)CNACaspofungin415002024-07-01
N-nitrosamines A81 化学结构N-nitroso-celiprolol3-(3-Acetyl-4-(3-(tert-butyl(nitroso)amino)-2-hydroxypropoxy)phenyl)-1,1-diethylureaCC(C1=C(OCC(O)CN(N=O)C(C)(C)C)C=CC(NC(N(CC)CC)=O)=C1)=ONACeliprolol515002023-11-15
N-nitrosamines A82 化学结构N-nitroso-cilazapril(1S, 9S)-9-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]nitrosoamino]octahydro-10-oxo-6H-pyridazino[1, 2-a][1, 2]diazepine-1-carboxylic AcidO=C([C@@H]1CCCN2N1C([C@@H](N([C@H](C(OCC)=O)CCC3=CC=CC=C3)N=O)CCC2)=O)O1053740-92-3Cilazapril515002023-07-01
N-nitrosamines A83 化学结构N-nitroso-cinacalcet(R)-N-(1-(naphthalen-1-yl)ethyl)-N-(3-(3-(trifluoromethyl)phenyl)propyl)nitrous amideC[C@H](C1=CC=CC2=CC=CC=C12)N(CCCC3=CC(=CC=C3)C(F)(F)F)N=ONACinacalcet34002023-12-15
N-nitrosamines A84 化学结构N-nitroso-ciprofloxacin1-cyclopropyl-6-fluoro-7-(4-nitrosopiperazin-1-yl)-4-oxoquinoline-3-carboxylic acidC1CC1N2C=C(C(=O)C3=CC(=C(C=C32)N4CCN(CC4)N=O)F)C(=O)O864443-44-7CiprofloxacinNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A85 化学结构N-nitroso-clozapine8-chloro-11-(4-methylpiperazin-1-yl)-5-nitroso-5H-dibenzo[b,e][1,4]diazepineCN1CCN(CC1)C/3=N\C2=C(C=CC(=C2)Cl)N(C4=CC=CC=C/34)N=O156632-03-0Clozapine515002024-02-15
N-nitrosamines A86 化学结构N-nitroso-clozapine EP Impurity C8-chloro-11-(4-nitrosopiperazin-1-yl)-5H-dibenzo[b, e][1, 4]diazepineN(N1CCN(CC1)C/3=N\C2=C(C=CC(=C2)Cl)NC4=CC=CC=C/34)=ONAClozapine34002024-02-15
N-nitrosamines A87 化学结构N-nitroso-cytisine(1R,5R)-3-Nitroso-1,2,3,4,5,6-hexahydro-8H-1,5-methanopyrido[1,2-a][1,5]diazocin-8-oneO=C3N2C([C@]1(CN(N=O)C[C@](C1)([H])C2)[H])=CC=C319634-60-7Cytisine34002025-12-01
N-nitrosamines A88 化学结构N-nitroso-dabigatran etexilateEthyl3-(2-(((4-(N-((hexyloxy)carbonyl)carbamimidoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoateC1=C3C(=CC=C1C(N(C2=NC=CC=C2)CCC(OCC)=O)=O)N(C(=N3)CN(N=O)C=4C=CC(=CC=4)C(=N)NC(=O)OCCCCCC)CNANNDDabigatran Etexilate1500Limit based on negative bacterial reverse mutation test2023-07-01
N-nitrosamines A89 化学结构N-nitroso-dabigatran etexilate amideEthyl 3-(2-(((4-(((hexyloxy)carbonyl)carbamoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N- (pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoateCN1C2=CC=C(C(N(C3=CC=CC=N3)CCC(OCC)=O)=O)C=C2N=C1CN(N=O)C4=CC=C(C(NC(OCCCCCC)=O)=O)C=C4NANNDHDabigatran Etexilate1500Limit derived using structure-activity-relationship (SAR)/read-across and weight of evidence approach using N-nitroso-dabigatran etexilate as a surrogate.2026-03-01
N-nitrosamines A90 化学结构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 acidClC8=C9OC=3C(O[C@@H]1O[C@@H]([C@@H](O)[C@H](O)[C@H]1NC(=O)CCCCCCCCC(C)C)C(O)=O)=C4OC%13=CC=C(CC2NC(=O)[C@@H](C%12=CC=C(OC%11=CC(C(NC2=O)C(=O)NC(C(C=3)=C4)C(=O)NC7C%10=CC(C=6C(O[C@H]5O[C@@H]([C@@H](O)[C@@H](O)[C@@H]5O)CO)=CC(O)=CC=6C(NC(=O)C(NC7=O)[C@H](O)C(=C8)C=C9)C(NCCCN(C)C)=O)=C(O)C=C%10)=C(Cl)C(O)=C%11)C(O)=C%12)N(C)N=O)C=C%13NADalbavancin415002025-02-01
N-nitrosamines A91 化学结构N-nitroso-daridorexant amine impurity5-chloro-4-methyl-2-(2-methyl-1-nitrosopyrrolidin-2-yl)-1H-benzo[d]imidazoleN1(C(CCC1)(C=2NC=3C(N=2)=C(C(=CC=3)Cl)C)C)N=ONAIDOR-1135-8758Daridorexant515002023-11-15
N-nitrosamines A92 化学结构N-nitroso-dasatinibN-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)(nitroso)amino)thiazole-5-carboxamideO=C(C3=CN=C(N(C1=NC(C)=NC(=C1)N2CCN(CC2)CCO)N=O)S3)NC4=C(C)C=CC=C4ClNADasatinib515002025-02-01
N-nitrosamines A93 化学结构N-nitroso-demethyl-roxithromycinN-((2S,3R,4S,6R)-2-(((3R,4S,5S,6R,7R,9R,11S,12R,13S,14R,E)-14-ethyl-7,12,13-trihydroxy-4-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-10-(((2-methoxyethoxy)methoxy)imino)-3,5,7,9,11,13-hexamethyl-2-oxooxacyclotetradecan-6-yl)oxy)-3-hydroxy-6-methyltetrahydro-2H-pyran-4-yl)-N-methylnitrous amideO=NN([C@@H]3[C@@H](O)[C@H](O[C@H]1[C@](C)(O)C[C@@H](C)/C([C@@H]([C@H]([C@@]([C@H](OC([C@@H]([C@H]([C@@H]1C)O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)C)=O)CC)(C)O)O)C)=N\OCOCCOC)O[C@H](C)C3)CNARoxithromycinNMILimit derived using structure-activity-relationship, physicochemical features and weight of evidence approach for N-nitroso-demethyl- roxithromycin based on N-nitroso-desmethyl-azithromycin. Can be controlled according to ICH Q3A/B.01 October 2026 (new)
N-nitrosamines A94 化学结构N-nitroso-desbutyldronedaron+B97:B139eN-(2-butyl-3-(4-(3-(butyl(nitroso)amino)propoxy)benzoyl)benzofuran-5-yl)methanesulfonamideCS(=O)(NC3=CC=C2OC(CCCC)=C(C(C1=CC=C(OCCCN(CCCC)N=O)C=C1)=O)C2=C3)=ONADronedarone1500Limit based on negative bacterial reverse mutation test2026-03-01
N-nitrosamines A95 化学结构N-nitroso-desbutyllumefantrine(Z)-N-Butyl-N-(2-(2,7-dichloro-9-(4-chlorobenzylidene)-9H-fluoren-4-yl)-2-hydroxyethyl)nitrous amideOC(C4=C3C1=CC=C(Cl)C=C1/C(=C/C2=CC=C(Cl)C=C2)C3=CC(Cl)=C4)CN(N=O)CCCCNALumefantrine1500Limit based on negative bacterial reverse mutation test2025-12-01
N-nitrosamines A96 化学结构N-nitroso-desethyl lidocaineN-(2,6-dimethylphenyl)-2-[ethyl(nitroso)amino]acetamideC1=CC=C(C(=C1C)NC(CN(CC)N=O)=O)CNALidocaine21002023-11-15
N-nitrosamines A97 化学结构N-nitroso-desformyl-riociguatN-(4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl)-N-methylnitrousCN(C1=C(N=C(N=C1N)C2=NN(C3=C2C=CC=N3)CC4=CC=CC=C4F)N)N=ONARiociguat21002024-07-01
N-nitrosamines A98 化学结构N-nitroso-desloratadine13-chloro-2-(1-nitrosopiperidin-4-ylidene)-4-azatricyclo [9.4.0.03,8]pentadeca-1(11),3(8),4,6,12,14-hexaeneC1CC2=C(C=CC(=C2)Cl)C(=C3CCN(CC3)N=O)C4=C1C=CC=N41246819-22-6Desloratadine34002023-07-01
N-nitrosamines A99 化学结构N-nitroso-desmethyl-azelastine4-(4-Chlorobenzyl)-2-(1-nitrosoazepan-4-yl)phthalazin-1(2H)-oneC1(CCN(CCC1)N=O)N/N=C(\C=2C(C(=O)C)=CC=CC=2)CC=3C=CC(=CC=3)ClNAAzelastine21002023-11-15
N-nitrosamines A100 化学结构N-nitroso-desmethyl-azithromycin(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-11-[(2S,3R,4S,6R)-3-hydroxy-6-methyl-4-(methylamino)oxan-2-yl]oxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-azacyclopentadecan-15-oneO=NN([C@H]1C[C@@H](C)O[C@H]([C@@H]1O)O[C@@H]1[C@@H](C)[C@H](O[C@@H]2O[C@@H](C)[C@@H]([C@](C2)(C)OC)O)[C@@H](C)C(=O)O[C@H](CC)[C@@]([C@@H]([C@H](N(C[C@@H](C[C@@]1(C)O)C)C)C)O)(C)O)CNAAzithromycinNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A101 化学结构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-carboxamideO=C([C@@H]1C[C@@]3([H])[C@@](N(C1)CC=C)([H])CC2=CNC4=C2C3=CC=C4)N(C(NCC)=O)CCCN(C)N=ONACabergoline1182025-02-01
N-nitrosamines A102 化学结构N-nitroso-desmethyl-chloropyramineN-[2-[(4-chlorophenyl)methyl-pyridin-2-ylamino]ethyl]-N-methylnitrous amideN(N(C)CCN(CC1=CC=C(C=C1)Cl)C2=CC=CC=N2)=ONAChloropyramine1182023-07-01
N-nitrosamines A103 化学结构N-nitroso-desmethyl-chlorphenamineN-(3-(4-Chlorophenyl)-3-(pyridin-2-yl)propyl)-N-methylnitrous AmideC1(=CC=C(C=C1)C(C=2N=CC=CC=2)CCN(C)N=O)ClNAChlorphenamine1182024-12-01
N-nitrosamines A104 化学结构N-nitroso-desmethyl-cidoxepinN-[(3Z)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)propyl]-N-methylnitrous amideCN(CC/C=C\1/C2=CC=CC=C2COC3=CC=CC=C31)N=ONADoxepin1182026-03-01
N-nitrosamines A105 化学结构N-nitroso-desmethyl-citalopram/ N-nitroso-desmethyl-escitalopramN-(3-(5-cyano-1-(4-fluorophenyl)-1, 3-dihydroisobenzofuran-1-yl)propyl)-N-methylnitrous amideC1=C(C=CC2=C1COC2(C3=CC=C(C=C3)F)CCCN(N=O)C)C#NNACitalopram100Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure.2023-12-15
N-nitrosamines A106 化学结构N-nitroso-desmethyl-clarithromycinN-[(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 amideCC[C@@H]1[C@@]([C@@H]([C@H](C(=O)[C@@H](C[C@@]([C@@H]([C@H]([C@@H]([C@H](C(=O)O1)C)O[C@H]2C[C@@]([C@H]([C@@H](O2)C)O)(C)OC)C)O[C@H]3[C@@H]([C@H](C[C@H](O3)C)N(C)N=O)O)(C)OC)C)C)O)(C)ONAClarithromycinNMILimit derived using structure-activity-relationship (SAR)/read-across and weight of evidence approach using N-nitroso-desmethyl-azithromycin as a surrogate. Can be controlled according to ICH Q3A/B.2024-07-01
N-nitrosamines A107 化学结构N-nitroso-desmethyl-diltiazem[(2S,3S)-2-(4-methoxyphenyl)-5-[2-[methyl(nitroso)amino]ethyl]-4-oxo-2,3-dihydro-1,5-benzothiazepin-3-yl] acetateCC(=O)O[C@@H]1[C@@H](SC2=CC=CC=C2N(C1=O)CCN(C)N=O)C3=CC=C(C=C3)OCNADiltiazem100Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure as substance tested positive in in vivo mutagenicity study01 March 2026 (note updated)
N-nitrosamines A108 化学结构N-nitroso-desmethyl-dimetindeneN-methyl-N-(2-(3-(1-(pyridin-2-yl)ethyl)-1H-inden-2-yl)ethyl)nitrous amideC1=CC=CC/2=C1C(\C(=C/2)CCN(C)N=O)C(C=3C=CC=CN=3)CNANO-DDMTDimetindene1182024-09-01
N-nitrosamines A109 化学结构N-nitroso-desmethyl-doxycycline(4S,5S,6R,12aR)-1,5,10,11,12a-pentahydroxy-6-methyl-4-[methyl(nitroso)amino]-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamideC[C@@H]1C2[C@@H](C3[C@@H](C(=O)C(=C([C@]3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)N=O)ONADoxycycline34002026-06-01
N-nitrosamines A110 化学结构N-nitroso-desmethyl-doxylamineN-methyl-N-(2-(1-phenyl-1-(pyridin-2-yl)ethoxy)ethyl)nitrous amideC1=CC=CC(=C1)C(C)(OCCN(N=O)C)C2=NC=CC=C2NADoxylamine100Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure.2025-08-01
N-nitrosamines A111 化学结构N-nitroso-desmethyl-edoxabanN-1-(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) oxalamideO=NN1CCC2=C(SC(C(N[C@H]3[C@@H](NC(C(NC4=NC=C(Cl)C=C4)=O)=O)CC[C@H](C(N(C)C)=O)C3)=O)=N2)C1NAEdoxaban21002024-05-01
N-nitrosamines A112 化学结构N-nitroso-desmethyl-eletriptan5-[2-(benzenesulfonyl)ethyl]-3-[[(2R)-1-nitrosopyrrolidin-2-yl]methyl]-1H-indoleC1C[C@@H](N(C1)N=O)CC2=CNC3=C2C=C(C=C3)CCS(=O)(=O)C4=CC=CC=C4NAEletriptan415002024-12-01
N-nitrosamines A113 化学结构N-nitroso-desmethyl-erythromycinN-[(2S,3R,4S,6R)-2-[[(3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-ethyl-7,12,13-trihydroxy-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-3,5,7,9,11,13-hexamethyl-2,10-dioxo-oxacyclotetradec-6-yl]oxy]-3-hydroxy-6-methyloxan-4-yl]-N-methylnitrous amideCC[C@@H]1[C@@]([C@@H]([C@H](C(=O)[C@@H](C[C@@]([C@@H]([C@H]([C@@H]([C@H](C(=O)O1)C)O[C@H]2C[C@@]([C@H]([C@@H](O2)C)O)(C)OC)C)O[C@H]3[C@@H]([C@H](C[C@H](O3)C)N(C)N=O)O)(C)O)C)C)O)(C)ONAErythromycinNMILimit derived using structure-activity-relationship, physicochemical features and weight of evidence approach for N-nitroso-desmethyl-erythromycin using N-nitroso-desmethyl-azithromycin as a surrogate. Can be controlled according to ICH Q3A/B.01 October 2026 (new)
N-nitrosamines A114 化学结构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[C@@]12(C[C@H](/C=C\[C@@]14C3=C(O2)C(OC)=CC=C3CN(CC4)N=O)O[H])[H]NAGalantamine1182024-12-01
N-nitrosamines A115 化学结构N-nitroso-desmethyl-lercanidipine3-(1-((3,3-diphenylpropyl)(nitroso)amino)-2-methylpropan-2-yl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylateO=C(C/1=C(/C)N/C(C)=C(/C(OC)=O)C/1C2=CC=CC([N+]([O-])=O)=C2)OC(C)(C)CN(CCC(C3=CC=CC=C3)C4=CC=CC=C4)N=ONALercanidipine21002025-02-01
N-nitrosamines A116 化学结构N-nitroso-desmethyl-lercanidipine impurity D3-(1-((3,3-diphenylpropyl)(nitroso)amino)-2-methylpropan-2-yl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylateO=C(C1=C(C)N=C(C)C(C(OC)=O)=C1C2=CC=CC([N+]([O-])=O)=C2)OC(C)(C)CN(CCC(C3=CC=CC=C3)C4=CC=CC=C4)N=ONALercanidipine21002025-02-01
N-nitrosamines A117 化学结构N-nitroso-desmethyl-maralixibat1-(4-((4-((4R,5R)-3,3-Dibutyl-4-hydroxy-7-(methyl(nitroso)amino)-1,1-dioxido-2,3,4,5-tetrahydrobenzo[b]thiepin-5-yl)phenoxy)methyl)benzyl)-1,4-diazabicyclo[2.2.2]octan-1-iumCCCCC6([C@@H]([C@H](C=1C=CC(=CC=1)OCC=2C=CC(=CC=2)C[N+]34CCN(CC3)CC4)C5=CC(N(N=O)C)=CC=C5S(C6)(=O)=O)O)CCCCNAMaralixibat1500Limit based on negative bacterial reverse mutation test01 October 2026 (new)
N-nitrosamines A118 化学结构N-nitroso-desmethyl-mifepristoneN-[4-[(8S,11R,13S,14S,17S)-17-hydroxy-13-methyl-3-oxo-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-11-yl]phenyl]-N-methylnitrous amideO=NN(C5=CC=C([C@H]\3C[C@]1(C)[C@@](C#CC)(O)CC[C@@]1([H])[C@]4([H])CCC/2=C\C(CCC/2=C\34)=O)C=C5)CNAMifepristone21002025-12-01
N-nitrosamines A119 化学结构N-nitroso-desmethyl-nintedanibMethyl (Z)-3-(((4-(N-methyl-2-(4-nitrosopiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylateN(N1CCN(CC1)CC(=O)N(C)C2=CC=C(C=C2)N\C(C3=CC=CC=C3)=C/4C(NC5=C/4C=CC(=C5)C(=O)OC)=O)=ONANintedanib34002023-12-15
N-nitrosamines A120 化学结构N-nitroso-desmethyl-rifampicinN-nitroso-desmethyl-rifampicinC=25C(/C=N/N1CCN(CC1)N=O)=C(C=3C(C=2O)=C(C(=C4C=3C([C@](O4)(C)O/C=C/[C@H](OC)[C@H]([C@@H](C)[C@@H]([C@H](O)[C@H](C)[C@@H](O)[C@@H](/C=C\C=C(\C(N5)=O)C)C)C)C)=O)C)O)O.OC(=O)CNARifampicin34002026-06-01
N-nitrosamines A121 化学结构N-nitroso-desmethyl-rivastigmine[3-[(1S)-1-[methyl(nitroso)amino] ethyl]phenyl] N-ethyl-N-methyl carbamateO(C1=CC=CC(C(N(N=O)C)C)=C1)C(N(C)CC)=ONARivastigmine21002024-09-01
N-nitrosamines A122 化学结构N-nitroso-desmethyl-rizatriptanN-methyl-N-[2-[5-(1,2,4-triazol-1-ylmethyl)-1H-indol-3-yl]ethyl]nitrous amideCN(CCC1=CNC2=C1C=C(C=C2)CN3C=NC=N3)N=ONARizatriptan1182024-12-01
N-nitrosamines A123 化学结构N-nitroso-desmethyl-sildenafil5-(2-ethoxy-5-((4-nitrosopiperazin-1-yl)sulfonyl)phenyl)-1-methyl-3-propyl-1H-pyrazolo[4, 3-d]pyrimidin-7(6H)-oneCCCC1=NN(C2=C1N=C(NC2=O)C3=C(C=CC(=C3)S(=O)(=O)N4CCN(CC4)N=O)OCC)CNASildenafil34002024-01-15
N-nitrosamines A124 化学结构N-nitroso-desmethyl-sumatriptanN-methyl-1-(3-(2-(methyl(nitroso)amino)ethyl)-1H-indol-5-yl)methanesulfonamideCNS(=O)(=O)CC1=CC2=C(C=C1)NC=C2CCN(N=O)CNASumatriptan1182024-01-15
N-nitrosamines A125 化学结构N-nitroso-desmethyl-tamoxifen(Z)-N-(2-(4-(1, 2-diphenylbut-1-en-1-yl)phenoxy)ethyl)-N-methylnitrous amideCC/C(=C(\C1=CC=CC=C1)C2=CC=C(C=C2)OCCN(N=O)C)C3=CC=CC=C3NATamoxifen1182024-02-15
N-nitrosamines A126 化学结构N-nitroso-desmethyl-tapentadolN-[3-(3-hydroxyphenyl)-2-methylpentyl]-N-methylnitrous amideCCC(C1=CC(=CC=C1)O)C(C)CN(C)N=ONATapentadol1182025-12-01
N-nitrosamines A127 化学结构N-nitroso-desmethyl-terbinafine(E)-N-(6,6-Dimethylhept-2-en-4-yn-1-yl)-N-(naphthalen-1-ylmethyl)nitrous amideCC(C)(C)C#C/C=C/CN(N=O)CC1=CC=CC2=CC=CC=C12NANDT, NHNATerbinafine1182024-01-15
N-nitrosamines A128 化学结构N-nitroso-desmethyl-tramadolN-[[(1R,2R)-2-hydroxy-2-(3-methoxyphenyl)cyclohexyl]methyl]-N-methylnitrous amideCN(C[C@H]1CCCC[C@@]1(C2=CC(=CC=C2)OC)O)N=ONATramadol1182024-07-01
N-nitrosamines A129 化学结构N-nitroso-desmethyl-trimebutine2-(Methyl(nitroso)amino)-2-phenylbutyl 3, 4, 5-trimethoxybenzoateCCC(COC(=O)C1=CC(=C(C(=C1)OC)OC)OC)(C2=CC=CC=C2)N(C)N=ONATrimebutine515002023-07-01
N-nitrosamines A130 化学结构N-nitroso-desmethyl-tripelennamineN-[2-[benzyl(pyridin-2-yl)amino]ethyl]-N-methylnitrous amideN(C)(CCN(CC1=CC=CC=C1)C2=CC=CC=N2)N=ONATripelennamine1182023-07-01
N-nitrosamines A131 化学结构N-nitroso-desmethyl-ulipristal acetate[(8S,11R,13S,14S,17R)-17-acetyl-13-methyl-11-[4-[methyl(nitroso)amino]phenyl]-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl] acetateCC(=O)[C@]1(CC[C@@H]2[C@@]1(C[C@@H](C3=C4CCC(=O)C=C4CC[C@@H]23)C5=CC=C(C=C5)N(C)N=O)C)OC(=O)CNDUPAUlipristal acetate21002026-03-01
N-nitrosamines A132 化学结构N-nitroso-desmethyl-zolmitriptanN-methyl-N-[2-[5-[[(4S)-2-oxo-1,3-oxazolidin-4-yl]methyl]-1H-indol-3-yl]ethyl]nitrous amideCN(CCC1=CNC2=C1C=C(C=C2)C[C@H]3COC(=O)N3)N=ONAZolmitriptan1182024-12-01
N-nitrosamines A133 化学结构N-nitroso-despropyl-ropiniroleN-(2-(2-oxoindolin-4-yl)ethyl)-N-propylnitrous amideO=C1NC2=C(C1)C(=CC=C2)CCN(N=O)CCCNARopinirole1182025-05-15
N-nitrosamines A134 化学结构N-nitroso-desvaleryl-valsartan(S)-2-(((2'-(1H-tetrazol-5-yl)- [1,1′-biphenyl]-4-yl) methyl)(nitroso)amino)- 3-methylbutanoic acidCC(C)[C@H](C(=O)O)N(CC1=CC=C(C=C1)C2=CC=CC=C2C3=NNN=N3)N=O2254485-68-0ValsartanNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2024-07-01
N-nitrosamines A135 化学结构N-nitroso-desvenlafaxineN-(2-(1-Hydroxycyclohexyl)-2-(4-hydroxyphenyl)ethyl)-N-methylnitrous amideC1=CC(=CC=C1C(CN(N=O)C)C2(CCCCC2)O)ONADesvenlafaxine1182023-11-15
N-nitrosamines A136 化学结构N-nitroso-diazepam Impurity DN-(2-benzoyl-4-chlorophenyl)-N-methylnitrous amideO=NN(C1=CC=C(Cl)C=C1C(C2=CC=CC=C2)=O)C51145-18-7Diazepam21002026-03-01
N-nitrosamines A137 化学结构N-nitroso-diclofenac2-[2-(2,6-dichloro-N-nitrosoanilino)phenyl]acetic acidC1=CC=C(C(=C1)CC(=O)O)N(C2=C(C=CC=C2Cl)Cl)N=O66505-80-4Diclofenac78000Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDPh as point of departure.2023-07-01
N-nitrosamines A138 化学结构N-nitroso-diethanolamineN,N-bis(2-hydroxyethyl)nitrous amideC(CO)N(CCO)N=O1116-54-7NDELA1900Low molecular weight nitrosamines with sufficiently robust toxicological data. Not all of these impurities have been found in medicines. Others have been found in 1 or more medicines, not necessarily related to the structure of the active substance or its related impurities. Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from carcinogenic potency database (CPDB) or Lhasa Carcinogenicity Database (LCD).2022-12-01
N-nitrosamines A139 化学结构N-nitroso-diethylamineN,N-diethylnitrous amideCCN(CC)N=O55-18-5NDEA26.5Low molecular weight nitrosamines with sufficiently robust toxicological data to serve as points of departure for derivation of other AIs by SAR and read-across. Not all of these impurities have been found in medicines. Others have been found in 1 or more medicines, not necessarily related to the structure of the active substance or its related impurities. Limit based on the harmonic mean TD50 database included on the carcinogenic potency database (CPDB).2020-06-01
N-nitrosamines A140 化学结构N-nitroso-diisopropanolamine1, 1'-(Nitrosoimino)bis-2-propanolC(N(CC(O)C)N=O)C(O)C53609-64-6NDIPLA34002024-02-15
N-nitrosamines A141 化学结构N-nitroso-diisopropylamineN,N-di(propan-2-yl)nitrous amideCC(C)N(C(C)C)N=O601-77-4NDIPA515002020-06-01
N-nitrosamines A142 化学结构N-nitroso-dimethylamineN,N-dimethylnitrous amideCN(C)N=O62-75-9NDMA96Low molecular weight nitrosamines with sufficiently robust toxicological data to serve as points of departure for derivation of other AIs by SAR and read-across. Not all of these impurities have been found in medicines. Others have been found in 1 or more medicines, not necessarily related to the structure of the active substance or its related impurities. Limit based on the harmonic mean TD50 database included on the carcinogenic potency database (CPDB).2020-06-01
N-nitrosamines A143 化学结构N-nitroso-di-n-butylamineN,N-dibutylnitrous amideCCCCN(CCCC)N=O924-16-3NDBA26.5Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDEA as point of departure.2020-06-01
N-nitrosamines A144 化学结构N-nitroso-diphenylamineN,N-diphenylnitrous amideC1=CC=C(C=C1)N(C2=CC=CC=C2)N=O86-30-6NDPh78000Nitrosamines with sufficiently robust toxicological data to serve as points of departure for derivation of other AIs by SAR and read-across. Not all of these impurities have been found in medicines. Others have been found in 1 or more medicines, not necessarily related to the structure of the active substance or its related impurities. Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from carcinogenic potency database (CPDB) applying the lower boundary of the 99% CI for the TD50 estimate (TD50L01).2022-12-01
N-nitrosamines A145 化学结构N-nitroso-donepezil impurity A5,6-dimethoxy-2-[(1-nitrosopiperidin-4-yl)methyl]-2,3-dihydro-1H-inden-1-oneCOC1=C(C=C2C(=C1)CC(C2=O)CC3CCN(CC3)N=O)OCNADonepezil340001 October 2026 (new)
N-nitrosamines A146 化学结构N-nitroso-dipropylamineN,N-dipropylnitrous amideCCCN(CCC)N=O621-64-7NDPA26.5Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDEA as point of departure.2021-10-01
N-nitrosamines A147 化学结构N-nitroso-doravirine dimerC1(=CC(=CC(=C1)Cl)C#N)OC2=C(C=CN(C2=O)CC=3N(C(N(N=3)CN(N=O)CN4N=C(N(C4=O)C)CN5C(C(=C(C=C5)C(F)(F)F)OC=6C=C(C=C(C=6)C#N)Cl)=O)=O)C)C(F)(F)FNANDDDoravirine1500Limit based on negative bacterial reverse mutation test2025-08-01
N-nitrosamines A148 化学结构N-nitroso-dorzolamide(4S, 6S)-4-(ethyl(nitroso)amino)-6-methyl-5, 6-dihydro-4H-thieno[2, 3-b]thiopyran-2-sulfonamide 7, 7-dioxideO=S(C(S1)=CC([C@@H](N(CC)N=O)C[C@@H]2C)=C1S2(=O)=O)(N)=ONADorzolamide1500Limit based on negative bacterial reverse mutation test2024-01-15
N-nitrosamines A149 化学结构N-nitroso-duloxetine(S)-N-methyl-N-(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)nitrous amideCN(N=O)CCC(OC1=C2C(C=CC=C2)=CC=C1)C3=CC=CS3NADuloxetine100Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure as substance tested positive in in vivo mutagenicity study2022-12-01
N-nitrosamines A150 化学结构N-nitroso-enalapril(2S)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]-nitrosoamino]propanoyl]pyrrolidine-2-carboxylic acidO=C(O)[C@H]1N(C([C@H](C)N([C@@H](CCC2=CC=CC=C2)C(OCC)=O)N=O)=O)CCC1NAEnalapril515002023-07-01
N-nitrosamines A151 化学结构N-nitroso-esmololMethyl 3-(4-(2-hydroxy-3-(isopropyl(nitroso)amino)propoxy)phenyl)propanoateCC(C)N(CC(COC1=CC=C(C=C1)CCC(=O)OC)O)N=ONAEsmolol415002023-11-15
N-nitrosamines A152 化学结构N-nitroso-ethylenediamine-triacetic acid2-[carboxymethyl-[2-[carboxymethyl(nitroso)amino] ethyl]amino]acetic acidOC(CN(CCN(N=O)CC(O)=O)CC(O)=O)=O862542-34-5Isosorbide mononitrate415002023-11-15
N-nitrosamines A153 化学结构N-nitroso-ethylisopropylamineN-ethyl-N-propan-2-ylnitrous amideCCN(C(C)C)N=O16339-04-1NEIPA34002020-06-01
N-nitrosamines A154 化学结构N-nitroso-fenfluramineN-ethyl-N-[1-[3-(trifluoromethyl)phenyl]propan-2-yl]nitrous amideCCN(C(C)CC1=CC(=CC=C1)C(F)(F)F)N=O19023-40-6Fenfluramine34002024-05-01
N-nitrosamines A155 化学结构N-nitroso-flecainideN-((1-Nitrosopiperidin-2-yl)methyl)-2, 5-bis(2, 2, 2-trifluoroethoxy)benzamideC1CCN(C(C1)CNC(=O)C2=C(C=CC(=C2)OCC(F)(F)F)OCC(F)(F)F)N=ONAFlecainide415002024-02-15
N-nitrosamines A156 化学结构N-nitroso-fluoxetineN-methyl-N-[3-phenyl-3-[4-(trifluoromethyl)phenoxy]propyl]nitrous amideCN(CCC(C1=CC=CC=C1)OC2=CC=C(C=C2)C(F)(F)F)N=O150494-06-7Fluoxetine100Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure as substance tested positive in in vivo mutagenicity study2022-12-01
N-nitrosamines A157 化学结构N-nitroso-folic acid(4-(((2-Amino-4-oxo-4,8-dihydropteridin-6-yl)methyl)(nitroso)amino)benzoyl)-L-glutamic acidC1=CC(=CC=C1C(=O)N[C@@H](CCC(=O)O)C(=O)O)N(CC2=CN=C3C(=N2)C(=O)NC(=N3)N)N=O26360-21-4NFAFolic acidNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2024-05-01
N-nitrosamines A158 化学结构N-nitroso-frovatriptan(6R)-6-[methyl(nitroso)amino]-6,7,8,9-tetrahydro-5H-carbazole-3-carboxamideCN([C@@H]1CCC2=C(C1)C3=C(N2)C=CC(=C3)C(=O)N)N=ONAFrovatriptan34002025-05-15
N-nitrosamines A159 化学结构N-nitroso-furosemide4-chloro-2-[furan-2-ylmethyl(nitroso)amino]-5-sulfamoylbenzoic acidC1=COC(=C1)CN(C2=CC(=C(C=C2C(=O)O)S(=O)(=O)N)Cl)N=ONAFurosemide1500Limit based on negative bacterial reverse mutation test2024-05-01
N-nitrosamines A160 化学结构N-nitroso-hydrochlorothiazide6-chloro-4-nitroso-1,1-dioxo-2,3-dihydro-1λ6,2,4-benzothiadiazine-7-sulfonamideC1NS(=O)(=O)C2=CC(=C(C=C2N1N=O)Cl)S(=O)(=O)N63779-86-2HydrochlorothiazideNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A161 化学结构N-nitroso-hydroxychloroquine EP Impurity CN-(4-((7-Chloroquinolin-4-yl)amino)pentyl)-N-(2-hydroxyethyl)nitrous amideOCCN(N=O)CCCC(NC1=CC=NC2=CC(Cl)=CC=C12)CNAHydroxychloroquine21002025-08-01
N-nitrosamines A162 化学结构N-nitroso-hydroxychloroquine EP Impurity DN-(4-((7-Chloroquinolin-4-yl)amino)pentyl)-N-ethylnitrous amideCC(NC2=C1C(C=C(Cl)C=C1)=NC=C2)CCCN(N=O)CCNSHydroxychloroquine1182025-08-01
N-nitrosamines A163 化学结构N-nitroso-hydroxyzine Impurity A1-((4-Chlorophenyl)(phenyl)methyl)-4-nitrosopiperazineClC3=CC=C(C(C1=CC=CC=C1)N2CCN(N=O)CC2)C=C32005-04-01Hydroxyzine34002025-08-01
N-nitrosamines A164 化学结构N-nitroso-imatinibN-(4-methyl-3-(nitroso(4-(pyridin-3-yl)pyrimidin-2-yl)amino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamideCC1=C(C=C(C=C1)NC(=O)C2=CC=C(C=C2)CN3CCN(CC3)C)N(C4=NC=CC(=N4)C5=CN=CC=C5)N=ONAImatinib515002023-12-15
N-nitrosamines A165 化学结构N-nitroso-iminodiacetic acid2-[carboxymethyl(nitroso)amino] acetic acidC(C(=O)O)N(CC(=O)O)N=O25081-31-6Isosorbide mononitrate415002023-11-15
N-nitrosamines A166 化学结构N-nitroso-iminodibenzyl2‐nitroso‐2‐azatricyclo[9.4.0.0³,⁸] pentadeca‐1(11),3(8),4,6,12,14‐hexaene)C1CC2=CC=CC=C2N(C3=CC=CC=C31)N=ONAMelipramin78000Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDPh as point of departure.2024-09-01
N-nitrosamines A167 化学结构N-nitroso-ivacaftorN-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1-nitroso-4-oxo-1,4-dihydroquinoline-3-carboxamideC1=CC=CC2=C1N(C=C(C2=O)C(N(C=3C(=CC(=C(C=3)O[H])C(C)(C)C)C(C)(C)C)[H])=O)N=ONAIvacaftor515002024-12-01
N-nitrosamines A168 化学结构N-nitroso-ketamineN-[1-(2-chlorophenyl)-2-oxocyclohexyl]-N-methylnitrous amideN(N(C1(CCCCC1=O)C2=CC=CC=C2Cl)C)=O86144-35-6Ketamine51500CPCA derived AI as substance tested positive in in vivo mutagenicity study. LTL cannot be applied and the AI will be capped at 1500ng2023-07-01
N-nitrosamines A169 化学结构N-nitroso-labetalol2-hydroxy-5-[1-hydroxy-2-[nitroso(4-phenylbutan-2-yl)amino]ethyl]benzamideCC(CCC1=CC=CC=C1)N(CC(C2=CC(=C(C=C2)O)C(=O)N)O)N=O2820170-74-7Labetalol1500Limit based on negative bacterial reverse mutation test2023-07-01
N-nitrosamines A170 化学结构N-nitroso-landiolol[(4S)-2,2-dimethyl-1,3-dioxolan-4-yl]methyl 3-[4-[(2S)-2-hydroxy-3-[2-(morpholine-4-carbonylamino)ethyl-nitrosoamino]propoxy]phenyl]propanoateCC1(OC[C@H](O1)COC(=O)CCC2=CC=C(C=C2)OC[C@H](CN(CCNC(=O)N3CCOCC3)N=O)O)CNALandiolol1500Limit based on negative bacterial reverse mutation test01 July 2023 (update of AI and notes)
N-nitrosamines A171 化学结构N-nitroso-leniolisibN-[6-[6-methoxy-5-(trifluoromethyl)pyridin-3-yl]-7,8-dihydro-5H-pyrido[4,3-d]pyrimidin-4-yl]-N-(1-propanoylpyrrolidin-3-yl)nitrous amideCCC(=O)N1CC[C@@H](C1)N(C2=NC=NC3=C2CN(CC3)C4=CC(=C(N=C4)OC)C(F)(F)F)N=ONAE6NALeniolisib515002023-11-15
N-nitrosamines A172 化学结构N-nitroso-levofloxacin(2S)-7-fluoro-2-methyl-6-(4-nitrosopiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.05,13]trideca-5(13),6,8,11-tetraene-11-carboxylic acidCC1COC2=C3N1C=C(C(=O)C3=CC(=C2N4CCN(CC4)N=O)F)C(=O)O1152314-62-9Levofloxacin415002023-07-01
N-nitrosamines A173 化学结构N-nitroso-lisinoprilN2-((S)-1-carboxy-3-phenylpropyl)-N2-nitroso-L-lysyl-L-prolineC1C[C@H](N(C1)C(=O)[C@H](CCCCN)N([C@@H](CCC2=CC=CC=C2)C(=O)O)N=O)C(=O)O519175-80-5LisinoprilNMILimit derived using structure-activity-relationship, physicochemical features and weight of evidence approach for N-nitroso-lisinopril based on N-nitroso-quinapril and N-nitroso-quinaprilat. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A174 化学结构N-nitroso-maprotilineN-(3-(9, 10-dihydro-9, 10-ethanoanthracen-9-yl)propyl)-N-methylnitrous amideCN(CCCC13CCC(C2=CC=CC=C12)C4=CC=CC=C34)N=O204268-61-1Maprotiline1182024-09-01
N-nitrosamines A175 化学结构N-nitroso-masitinib4-[(4-Nitrosopiperazin-1-yl)methyl]-N-(4-methyl-3-{[4-(pyridin-3-yl)-1,3-thiazol-2-yl]amino}phenyl)benzamideCC1=C(C=C(C=C1)NC(=O)C2=CC=C(C=C2)CN3CCN(CC3)N=O)NC4=NC(=CS4)C5=CN=CC=C5NAMasitinib34002024-02-15
N-nitrosamines A176 化学结构N-nitroso-mefenamic acid2-(2,3-dimethyl-N-nitrosoanilino)benzoic acidCC1=C(C(=CC=C1)N(C2=CC=CC=C2C(=O)O)N=O)C2114-63-8Mefenamic acid78000Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDPh as point of departure.2022-12-01
N-nitrosamines A177 化学结构N-nitroso-meglumineN-methyl-N-(2,3,4,5,6-pentahydroxyhexyl)nitrous amideCN(CC(C(C(C(CO)O)O)O)O)N=O62137-31-9Meglumine2100CPCA derived AI as substance tested positive in in vivo mutagenicity study2024-02-15
N-nitrosamines A178 化学结构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 acidC[C@H]/2C1C(C(=O)N1\C(=C/2S[C@H]3C[C@H](N(C3)N=O)C(=O)N(C)C)C(=O)O)[C@@H](C)ONAMeropenem415002024-02-15
N-nitrosamines A179 化学结构N-nitroso-metamizole impurity E[(1,5-dimethyl-3-oxo-2-phenylpyrazol-4-yl)-nitrosoamino]methanesulfonic acidCC1=C(C(=O)N(N1C)C2=CC=CC=C2)N(CS(=O)(=O)O)N=ONAMetamizole415002026-06-01
N-nitrosamines A180 化学结构N-nitroso-methylaminoantipyrineN-(1,5-dimethyl-3-oxo-2-phenylpyrazol-4-yl)-N-methylnitrous amideN(C1=C(N(C)N(C1=O)C2=CC=CC=C2)C)(C)N=O73829-38-6NMAAMetamizole21002025-08-01
N-nitrosamines A181 化学结构N-nitroso-methylethanolamineN-(2-hydroxyethyl)-N-methylnitrous amideCN(CCO)N=O26921-68-6NMELANefopam21002025-08-01
N-nitrosamines A182 化学结构N-nitroso-methylethylamineN-ethyl-N-methylnitrous amideCCN(C)N=O10595-95-6NMEAAmphotericin B26.5Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDEA as point of departure.2026-03-01
N-nitrosamines A183 化学结构N-nitroso-methylphenidatemethyl 2-(1-nitrosopiperidin-2-yl)-2-phenylacetateCOC(=O)C(C1CCCCN1N=O)C2=CC=CC=C255557-03-4NMPHMethylphenidate1300Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of N-nitrosopiperidine as point of departure.2022-05-01
N-nitrosamines A184 化学结构N-nitroso-metoprololN-[2-hydroxy-3-[4-(2-methoxyethyl)phenoxy]propyl]-N-propan-2-ylnitrous amideCC(C)N(CC(COC1=CC=C(C=C1)CCOC)O)N=O134720-05-1Metoprolol415002023-07-01
N-nitrosamines A185 化学结构N-nitroso-mirabegron(R)-2-(2-Aminothiazol-4-yl)-N-(4-(2-((2-hydroxy-2-phenylethyl)(nitroso)amino)ethyl)phenyl)acetamideO=C(CC1=CSC(N)=N1)NC(C=C2)=CC=C2CCN(N=O)C[C@H](O)C3=CC=CC=C3NAMirabegron3400CPCA derived AI as substance tested positive in in vivo mutagenicity study2023-07-01
N-nitrosamines A186 化学结构N-nitroso-mirabegron EP Impurity BN-(4-aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amideC1=CC=C(C=C1)C(CN(CCC2=CC=C(C=C2)N)N=O)ONAMBL-3-NOMirabegron34002024-05-01
N-nitrosamines A187 化学结构N-nitroso-mirdametinibN-(2,3-dihydroxypropoxy)-3,4-difluoro-2-((2-fluoro-4-iodophenyl)(nitroso)amino)benzamideOCC(O)CONC(=O)C1=C(N(N=O)C2=C(F)C=C(I)C=C2)C(F)=C(F)C=C1NAMirdametinib78000Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDPh as point of departure2025-08-01
N-nitrosamines A188 化学结构N-nitroso-mirtazapine2-nitroso-1, 2, 3, 4, 10, 14b-hexahydrobenzo[c]pyrazino[1, 2-a]pyrido[3, 2-f]azepineN(N1CCN3C(C1)C2=CC=CC=C2CC4=C3N=CC=C4)=ONAMirtazapine34002024-01-15
N-nitrosamines A189 化学结构N-nitroso-morpholine4-nitrosomorpholineC1COCCN1N=O59-89-2NMOR127Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from carcinogenic potency database (CPDB) or Lhasa Carcinogenicity Database (LCD). Low molecular weight nitrosamines with sufficiently robust toxicological data to serve as points of departure for derivation of other AIs by SAR and read-across. Not all of these impurities have been found in medicines. Others have been found in 1 or more medicines, not necessarily related to the structure of the active substance or its related impurities.2021-06-01
N-nitrosamines A190 化学结构N-nitroso-moxifloxacin1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-1-nitrosooctahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acidO=C(C1=CN(C2CC2)C3=C(C=C(F)C(N(C4)C[C@]5([H])[C@@]4([H])CCCN5N=O)=C3OC)C1=O)ONAMoxifloxacin41500CPCA derived AI as substance showed inconclusive results in in vivo mutagenicity study2023-07-01
N-nitrosamines A191 化学结构N-nitroso-N-des(prop-2-enoyl)-remibrutinibN-(3-(6-Amino-5-(2-(methyl(nitroso)amino)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamideCN(CCOC1=C(C2=C(C)C(NC(C3=CC=C(C4CC4)C=C3F)=O)=CC(F)=C2)N=CN=C1N)N=ONALOU064-F8-NORemibrutinib100Limit derived using structure-activity-relationship, physicochemical features and weight of evidence approach using the TD50 of NNK as point of departure2026-06-01
N-nitrosamines A192 化学结构N-nitroso-N-descyclopropanecarbaldehyde olaparib4-(4-Fluoro-3-(4-nitrosopiperazine-1-carbonyl)benzyl)phthalazin-1(2H)-oneO=C3NN=C(CC2=CC=C(F)C(C(N1CCN(N=O)CC1)=O)=C2)C4=C3C=CC=C42742659-74-9OlaparibActive substance itself is clastogenic. Can be controlled according to ICH Q3A/B.2026-03-01
N-nitrosamines A193 化学结构N-nitroso-N-deshydroxyethyl-dasatinibN-(2-chloro-6-methylphenyl)-2-[[2-methyl-6-(4-nitrosopiperazin-1-yl)pyrimidin-4-yl]amino]-1,3-thiazole-5-carboxamideCC1=C(C(=CC=C1)Cl)NC(=O)C2=CN=C(S2)NC3=CC(=NC(=N3)C)N4CCN(CC4)N=ONADasatinib34002025-02-01
N-nitrosamines A194 化学结构N-nitroso-N-desmethyl-dextromethorphan(4bS,8aS,9S)-3-methoxy-11-nitroso-6,7,8,8a,9,10-hexahydro-5H-9,4b-(epiminoethano)phenanthreneN(N2CC[C@@]13CCCC[C@@H]1[C@@H]2CC4=C3C=C(C=C4)OC)=ONADextromethorphan415002020-05-01
N-nitrosamines A195 化学结构N-nitroso-N-desmethyl-diphenhydramineN-(2-benzhydryloxyethyl)-N-methylnitrous amideCN(CCOC(C1=CC=CC=C1)C2=CC=CC=C2)N=O55855-43-1Dimenhydrinate/ Diphenhydramine100Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure.2024-07-01
N-nitrosamines A196 化学结构N-nitroso-N-desmethyl-mianserin2-Nitroso-1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepineO=NN1CCN2C3=CC=CC=C3CC4=C(C=CC=C4)C2C1NANAMianserin34002025-02-01
N-nitrosamines A197 化学结构N-nitroso-nebivololN,N-bis[2-(6-fluoro-3,4-dihydro-2H-chromen-2-yl)-2-hydroxyethyl]nitrous amideC1CC2=C(C=CC(=C2)F)OC1C(CN(CC(C3CCC4=C(O3)C=CC(=C4)F)O)N=O)O1391051-68-5NNEBNebivololNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A198 化学结构N-nitroso-N-ethyl-benzylamineN-benzyl-N-ethylnitrous amideCCN(CC1=CC=CC=C1)N=O20689-96-7NBEA1182024-05-01
N-nitrosamines A199 化学结构N-nitroso-N-ethyl-valaciclovir2-[(2-amino-6-oxo-1H-purin-9-yl)methoxy]ethyl 2-[ethyl(nitroso)amino]-3-methylbutanoateO=NN(CC)C(C(C)C)C(OCCOCN1C=NC2=C1N=C(N)NC2=O)=ONAValaciclovir34002023-07-01
N-nitrosamines A200 化学结构N-nitroso-N-methyl-benzylamineN-benzyl-N-methylnitrous amideCN(CC1=CC=CC=C1)N=O937-40-6NMBzA11801 October 2026 (new)
N-nitrosamines A201 化学结构N-nitroso-nilotinib4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-(nitroso(4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamideO=C(C3=CC(N(N=O)C2=NC(C1=CN=CC=C1)=CC=N2)=C(C)C=C3)NC5=CC(C(F)(F)F)=CC(N4C=NC(C)=C4)=C52925306-68-7Nilotinib515002024-12-01
N-nitrosamines A202 化学结构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)pentanamideC1(=CC(=CC2=C1C[C@@H](CC2)N[C@H](C(NC=3N=CN(C=3)C(CN(CC(C)(C)C)N=O)(C)C)=O)CCC)F)FNANirogacestat1500Limit based on negative bacterial reverse mutation test2025-08-01
N-nitrosamines A203 化学结构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)pentanamideFC1=C(C[C@H]2N(N=O)[C@@H](CCC)C(NC(N=C3)=CN3C(C)(C)CNCC(C)(C)C)=O)C(CC2)=CC(F)=C1NANirogacestat515002025-08-01
N-nitrosamines A204 化学结构N-nitroso-N-methyl-2-phenylethylamineN-methyl-N-(2-phenylethyl)nitrous amideCN(CCC1=CC=CC=C1)N=O13256-11-6NMPEA8Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from the Lhasa Carcinogenicity Database (LCDB).2022-05-01
N-nitrosamines A205 化学结构N-nitroso-N-methyl-4-aminobutyric acid4-[methyl(nitroso)amino]butanoic acidCN(CCCC(=O)O)N=O61445-55-4NMBA415002020-06-01
N-nitrosamines A206 化学结构N-nitroso-N-methylanilineN-methyl-N-phenylnitrous amideCN(C1=CC=CC=C1)N=O614-00-6NMPA21002020-08-01
N-nitrosamines A207 化学结构N-nitroso-N-methyl-valaciclovir2-[(2-amino-6-oxo-1H-purin-9-yl)methoxy]ethyl 3-methyl-2-[methyl(nitroso)amino]butanoateCC(C)[C@@H](C(=O)OCCOCN1C=NC2=C1N=C(NC2=O)N)N(C)N=ONAValaciclovir1500Limit based on negative bacterial reverse mutation test2023-07-01
N-nitrosamines A208 化学结构N-nitroso-norfloxacin1-Ethyl-6-fluoro-7-(4-nitrosopiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acidO=C(C1=CN(CC)C2=C(C=C(F)C(N3CCN(N=O)CC3)=C2)C1=O)O74011-53-3NorfloxacinNMILimit derived using structure-activity-relationship (SAR)/read-across approach using the negative in vivo mutagenicity study of n-nitroso-ciprofloxacin as point of departure. Can be controlled according to ICH Q3A/B.2025-02-01
N-nitrosamines A209 化学结构N-nitroso-nornicotine3-[(2S)-1-nitrosopyrrolidin-2-yl]pyridineC1C[C@H](N(C1)N=O)C2=CN=CC=C216543-55-8Nicotine100Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NNK as point of departure as substance is considered a human carcinogen by the International Agency for Research on Cancer2024-12-01
N-nitrosamines A210 化学结构N-nitroso-nor-oxycodone(4R,4aS,7aS,12bS)-4a-hydroxy-9-methoxy-3-nitroso-2,3,4,4a,5,6-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7aH)-oneC1=CC(=C2C3=C1C[C@@]5([C@@]4(CCC([C@@](O2)([C@@]34CC(N5N=O)([H])[H])[H])=O)O[H])[H])OC([H])[H]NANalmefene415002024-12-01
N-nitrosamines A211 化学结构N-nitroso-nortriptylineN-methyl-N-[3-(2-tricyclo[9.4.0.0^3,8] pentadeca-1(15),3,5,7,11,13-hexaenylidene)propyl]nitrous amideCN(CCC=C1C2=CC=CC=C2CCC3=CC=CC=C31)N=O55855-42-0Amitriptyline, Nortryptyline118CPCA derived AI as substance tested positive in in vivo mutagenicity study2022-05-01
N-nitrosamines A212 化学结构N-nitroso-orphenadrineN-Methyl-N-(2-(phenyl(o-tolyl)methoxy)ethyl)nitrous AmideCC1=CC=CC=C1C(C2=CC=CC=C2)OCCN(N=O)CNAOrphenadrine1182023-07-01
N-nitrosamines A213 化学结构N-nitroso-paroxetine(3S,4R)-3-(1,3-benzodioxol-5-yloxymethyl)-4-(4-fluorophenyl)-1-nitrosopiperidineC1CN(CC(C1C2=CC=C(C=C2)F)COC3=CC4=C(C=C3)OCO4)N=O2361294-43-9Paroxetine1500Limit based on negative bacterial reverse mutation test2022-12-01
N-nitrosamines A214 化学结构N-nitroso-p-chloro-benzylamino-pyridineN-[(4-chlorophenyl)methyl]-N-pyridin-2-ylnitrous amideC1(=CC=C(C=C1)CN(C2=NC=CC=C2)N=O)ClNAN-CBAPChloropyramine21002023-07-01
N-nitrosamines A215 化学结构N-nitroso-perindopril(2S,3aS,7aS)-1-[(2S)-2-[[(2S)-1-ethoxy-1-oxopentan-2-yl]-nitrosoamino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic acidCCC[C@H](N([C@H](C(=O)N1[C@H]2CCCC[C@H]2C[C@H]1C(=O)O)C)N=O)C(=O)OCCNAPerindoprilNMILimit derived using structure-activity-relationship (SAR)/read-across approach using the negative in vivo mutagenicity study of n-nitroso-ramipril as point of departure. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A216 化学结构N-nitroso-phenoxybenzamine HCl impurity A N-(2-Hydroxyethyl)-N-(1-phenoxypropan-2-yl)nitrous amideC1=CC=CC(=C1)OCC(N(CCO)N=O)CNANDB-APhenoxybenzamine HCl4150001 October 2026 (new)
N-nitrosamines A217 化学结构N-nitroso-phenoxybenzamine HCl impurity BN-Benzyl-N-(1-phenoxypropan-2-yl)nitrous amideC1=CC=CC(=C1)OCC(N(CC=2C=CC=CC=2)N=O)CNANDB-BPhenoxybenzamine HCl340001 October 2026 (new)
N-nitrosamines A218 化学结构N-nitroso-phenylephrineN-[(2R)-2-hydroxy-2-(3-hydroxyphenyl)ethyl]-N-methylnitrous amideCN(N=O)CC(O)C1=CC(O)=CC=C178658-64-7Phenylephrine21002023-07-01
N-nitrosamines A219 化学结构N-nitroso-piperazine1-nitrosopiperazineC1CN(CCN1)N=O5632-47-3NPZ34002023-07-01
N-nitrosamines A220 化学结构N-nitroso-piperidine1-nitrosopiperidineC1CCN(CC1)N=O100-75-4Piperidine1300Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from carcinogenic potency database (CPDB) or Lhasa Carcinogenicity Database (LCD). Low molecular weight nitrosamines with sufficiently robust toxicological data to serve as points of departure for derivation of other AIs by SAR and read-across. Not all of these impurities have been found in medicines. Others have been found in 1 or more medicines, not necessarily related to the structure of the active substance or its related impurities.2022-05-01
N-nitrosamines A221 化学结构N-nitroso-posaconazole impurity 11-(4-(((3R,5R)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)-4-nitrosopiperazineN(=O)N1CCN(CC1)C2=CC=C(C=C2)OC[C@H]3C[C@](OC3)(CN4C=NC=N4)C5=C(C=C(C=C5)F)FNAPosaconazole34002024-05-01
N-nitrosamines A222 化学结构N-nitroso-pramipexoleN-(2-amino-4, 5, 6, 7-tetrahydrobenzo[d]thiazol-6-yl)-N-propylnitrous amideC=12CC[C@@H](CC=1SC(=N2)N)N(CCC)N=ONAPramipexole34002023-07-01
N-nitrosamines A223 化学结构N-nitroso-praziquanamine2-Nitroso-2,3,6,7-tetrahydro-1H-pyrazino[2,1-a]isoquinolin-4(11bH)-oneO=C(CN(N=O)C1)N2C1C3=CC=CC=C3CC2NAArpraziquantel415002023-07-01
N-nitrosamines A224 化学结构N-nitroso-prolinamide(S)-1-Nitrosopyrrolidine-2-carboxamideC1C[C@H](N(C1)N=O)C(=O)NNAVildagliptin415002026-06-01
N-nitrosamines A225 化学结构N-nitroso-prolinenitrile(S)-1-Nitrosopyrrolidine-2-carbonitrileC1C[C@H](N(C1)N=O)C#NNAVildagliptin415002026-06-01
N-nitrosamines A226 化学结构N-nitroso-propafenonN-(2-hydroxy-3-(2-(3-phenylpropanoyl)phenoxy)propyl)-N-propylnitrous amideO=C(CCC1=CC=CC=C1)C2=CC=CC=C2OCC(CN(N=O)CCC)ONAPropafenon21002024-09-01
N-nitrosamines A227 化学结构N-nitroso-propafenone impurity B(R,E)-N-(3-(2-cinnamoylphenoxy)-2-hydroxypropyl)-N-propylnitrous amideO=NN(C[C@@H](O)COC1=CC=CC=C1C(/C=C/C2=CC=CC=C2)=O)CCCNAPropafenon21002025-08-01
N-nitrosamines A228 化学结构N-nitroso-propranololN-(2-hydroxy-3-naphthalen-1-yloxypropyl)-N-propan-2-ylnitrous amideCC(C)N(CC(COC1=CC=CC2=CC=CC=C21)O)N=O84418-35-9Propranolol415002023-07-01
N-nitrosamines A229 化学结构N-nitroso-pseudoephedrine/ N-nitrosoephedrineN-(1-hydroxy-1-phenylpropan-2-yl)-N-methylnitrous amideCC(C(C1=CC=CC=C1)O)N(C)N=OPseudoephedrine415002023-07-01
N-nitrosamines A230 化学结构N-nitroso-pyrrolidine1-nitrosopyrrolidineC1CCN(C1)N=O930-55-2NPYR1700Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from carcinogenic potency database (CPDB) or Lhasa Carcinogenicity Database (LCD). Low molecular weight nitrosamines with sufficiently robust toxicological data to serve as points of departure for derivation of other AIs by SAR and read-across. Not all of these impurities have been found in medicines. Others have been found in 1 or more medicines, not necessarily related to the structure of the active substance or its related impurities.2022-12-01
N-nitrosamines A231 化学结构N-nitroso-quetiapine HEEP impurity2-(2-(4-nitrosopiperazin-1-yl)ethoxy)ethan-1-olC1CN(CCN1CCOCCO)N=O73486-81-4Quetiapine1500Limit based on negative bacterial reverse mutation test2023-12-15
N-nitrosamines A232 化学结构N-nitroso-quinapril(3S)-2-[(2S)-2-[[(2S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl]-nitrosoamino]propanoyl]-3,4-dihydro-1H-isoquinoline-3-carboxylic acidCCOC(=O)C(CCC1=CC=CC=C1)N(C(C)C(=O)N2CC3=CC=CC=C3CC2C(=O)O)N=O158522-79-3QuinaprilNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A233 化学结构N-nitroso-ramipril(2S,3aS,6aS)-1-(N-((S)-1-ethoxy-1-oxo-4-phenylbutan-2-yl)-N-nitroso-L-alanyl)octahydrocyclopenta[b]pyrrole-2-carboxylic acidCCOC([C@@H](N(N=O)[C@@H](C)C(N1[C@](CCC2)([H])[C@]2([H])C[C@H]1C(O)=O)=O)CCC3=CC=CC=C3)=ONARamiprilNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2023-07-01
N-nitrosamines A234 化学结构N-nitroso-ranolazine impurity 11-(2-Methoxyphenoxy)-3-(4-nitrosopiperazin-1-yl)propan-2-olC1=C(C(=CC=C1)OCC(CN2CCN(CC2)N=O)O)OCNARanolazine34002024-01-15
N-nitrosamines A235 化学结构N-nitroso-rasagilineN-[(1R)-2,3-dihydro-1H-inden-1-yl]-N-prop-2-ynylnitrous amideC#CCN(C1CCC2=CC=CC=C12)N=O
C		2470278-90-9Rasagiline21002023-07-01
N-nitrosamines A236 化学结构N-nitroso-reboxetine(R)-2-((R)-(2-ethoxyphenoxy)(phenyl)methyl)-4-nitrosomorpholineCCOC1=CC=CC=C1O[C@@H]([C@H]2CN(CCO2)N=O)C3=CC=CC=C3NAReboxetine127Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NMOR as point of departure, as substance tested positive in in vivo mutagenicity study.2023-07-01
N-nitrosamines A237 化学结构N-nitroso-relebactam(1S,2R,5R)-2-((1-nitrosopiperidin-4-yl)carbamoyl)-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl hydrogen sulfateO=S(O)(ON3[C@]2([H])CC[C@H](C(NC1CCN(N=O)CC1)=O)N(C2)C3=O)=ONARelebactam34002026-06-01
N-nitrosamines A238 化学结构N-nitroso-remibrutinibN-(3-(6-Amino-5-(2-(methyl(nitroso)amino)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamideCN(CCOC1=C(C2=C(C)C(NC(C3=CC=C(C4CC4)C=C3F)=O)=CC(F)=C2)N=CN=C1N)N=ONARemibrutinib100Limit derived using structure-activity-relationship, physicochemical features and weight of evidence approach using the TD50 of NNK as point of departure2026-03-01
N-nitrosamines A239 化学结构N-nitroso-ribociclib impurity 17-cyclopentyl-N,N-dimethyl-2-((5-(4-nitrosopiperazin-1-yl)pyridine-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamideCN(C)C(=O)C2=CC1=CN=C(N=C1N2C3CCCC3)NC4=NC=C(C=C4)N5CCN(CC5)N=ONARibociclib3400CPCA derived AI as substance tested positive in in vivo mutagenicity study2024-01-15
N-nitrosamines A240 化学结构N-nitroso-ritalinic acid2-(1-nitrosopiperidin-2-yl)-2-phenylacetic acidC1CCN(C(C1)C(C2=CC=CC=C2)C(=O)O)N=ONAMethylphenidate415002024-02-15
N-nitrosamines A241 化学结构N-nitroso-rivaroxaban amide(S)-5-chloro-N-(2-hydroxy-3-(nitroso (4-(3-oxomorpholino)phenyl)amino) propyl)thiophene-2-carboxamideC1COCC(=O)N1C2=CC=C(C=C2)N(C[C@@H](O)CNC(=O)C3=CC=C(S3)Cl)N=ONARivaroxaban415002024-01-15
N-nitrosamines A242 化学结构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 acidC(COCCN(C1=CC=C(C=C1)N2CC(OC2=O)CNC(=O)C3=CC=C(S3)Cl)N=O)(=O)ONARivaroxaban415002024-01-15
N-nitrosamines A243 化学结构N-nitroso-safinamide(2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methyl-nitrosoamino]propanamideC[C@@H](C(=O)N)N(CC1=CC=C(C=C1)OCC2=CC(=CC=C2)F)N=O2657645-00-4Safinamide34002025-05-15
N-nitrosamines A244 化学结构N-nitroso-salbutamolN-tert-butyl-N-[2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethyl]nitrous amideCC(C)(C)N(CC(C1=CC(=C(C=C1)O)CO)O)N=ONASalbutamol515002023-07-01
N-nitrosamines A245 化学结构N-nitroso-sarcosine2-[methyl(nitroso)amino]acetic acidCN(CC(=O)O)N=ONANSARTroriluzole415002025-02-01
N-nitrosamines A246 化学结构N-nitroso-selumetinib6-(4-bromo-2-chloro-N-nitrosoanilino)-7-fluoro-N-(2-hydroxyethoxy)-3-methylbenzimidazole-5-carboxamideCN1C=NC2=C1C=C(C(=C2F)N(C3=C(C=C(C=C3)Br)Cl)N=O)C(=O)NOCCONASelumetinib78000Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of NDPh as point of departure.2025-12-01
N-nitrosamines A247 化学结构N-nitroso-sertralineN-(4-(3, 4-dichlorophenyl)-1, 2, 3, 4-tetrahydronaphthalen-1-yl)-N-methylnitrous amideN(C1CCC(C2=CC=CC=C12)C3=CC(=C(C=C3)Cl)Cl)(C)N=ONASertraline2100CPCA derived AI as substance tested positive in in vivo mutagenicity study2023-07-01
N-nitrosamines A248 化学结构N-nitroso-silodosin1-(3-hydroxypropyl)-5-[(2R)-2-[nitroso-[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-dihydroindole-7-carboxamideCC(CC1=CC2=C(C(=C1)C(=O)N)N(CC2)CCCO)N(CCOC3=CC=CC=C3OCC(F)(F)F)N=ONASilodosin415002024-02-15
N-nitrosamines A249 化学结构N-nitroso-sotalolN-[4-[1-hydroxy-2-[nitroso(propan-2-yl)amino]ethyl]phenyl]methanesulfonamideCC(C)N(CC(C1=CC=C(C=C1)NS(=O)(=O)C)O)N=O134720-07-3Sotalol415002023-07-01
N-nitrosamines A250 化学结构N-nitroso-tamsulosin5-[(2R)-2-[2-(2-ethoxyphenoxy)ethyl-nitrosoamino]propyl]-2-methoxybenzenesulfonamideCCOC1=CC=CC=C1OCCN(C(C)CC2=CC(=C(C=C2)OC)S(=O)(=O)N)N=O2892260-31-8Tamsulosin415002023-07-01
N-nitrosamines A251 化学结构N-nitroso-terazosin impurity C6, 7-Dimethoxy-2-(1-piperazinyl)-4-quinazolinamine; 2-(1-Piperazinyl)-4-amino-6, 7-dimethoxyquinazolineCOC1=C(C=C2C(=C1)C(=NC(=N2)N3CCN(CC3)N=O)N)OC60547-97-9Terazosin34002024-02-15
N-nitrosamines A252 化学结构N-nitroso-terazosin impurity N(4-Nitrosopiperazin-1-yl) (tetrahydrofuran-2-yl)methanoneC1CC(OC1)C(=O)N2CCN(CC2)N=O2470438-57-2Terazosin34002024-02-15
N-nitrosamines A253 化学结构N-nitroso-terbinafine degradantN-[(2E)-6,6-dimethyl-2-hepten-4-yn-1-yl]-N-nitrosomethanamineC(N(C)N=O)/C=C/C#CC(C)(C)CNANTD, NHMA1182024-01-15
N-nitrosamines A254 化学结构N-nitroso-terbinafine impurity AN-methyl-N-(napthalen-1-ylmethyl)nitrous amideC1=CC=CC2=C1C(=CC=C2)CN(N=O)C296760-88-8NTA, NMNATerbinafine1182024-01-15
N-nitrosamines A255 化学结构N-nitroso-tetracaine2-(dimethylamino)ethyl 4-(butyl(nitroso)amino)benzoateCCCCN(C1=CC=C(C=C1)C(=O)OCCN(C)C)N=ONATetracaine34002023-11-15
N-nitrosamines A256 化学结构N-nitrosamines A256 化学结构N-nitroso-ticagrelorN-((1R, 2S)-2-(3, 4-difluorophenyl)cyclopropyl)-N-(3-((1R, 2S, 3S, 4S)-2, 3-dihydroxy-4-(2-hydroxyethoxy)cyclopentyl)-5-(propylthio)-3H-[1, 2, 3]triazolo[4, 5-d]pyrimidin-7-yl)nitrous amideCCCSC1=NC(=C2C(=N1)N(N=N2)[C@@H]3C[C@@H]([C@H]([C@H]3O)O)OCCO)N([C@@H]4C[C@H]4C5=CC(=C(C=C5)F)F)N=O2476859-55-7Ticagrelor515002023-11-15
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-carboxamideCC(C)(C)N(CC(=O)NC4=CC(=C3C[C@@H]/2C[C@@H]1[C@H](/C(O)=C(\C([C@@]1(\C(O)=C/2C(C3=C4O)=O)O)=O)C(=O)N)N(C)C)N(C)C)N=ONATigecyclineNMISubstance tested negative in in vivo mutagenicity study. Can be controlled according to ICH Q3A/B.2024-07-01
N-nitrosamines A258 化学结构N-nitroso-torasemideN-(Isopropylcarbamoyl)-4-(nitroso(m-tolyl)amino)pyridine-3-sulfonamideO=[S](NC(NC(C)C)=O)(C1=CN=CC=C1N(N=O)C2=CC(C)=CC=C2)=ONATorasemide5150001 October 2026 (new)
N-nitrosamines A259 化学结构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 acidO=C(N1[C@](CCCC2)([H])[C@@]2([H])C[C@H]1C(O)=O)[C@H](C)N(N=O)[C@H](C(OCC)=O)CCC3=CC=CC=C3NATrandolapril515002024-07-01
N-nitrosamines A260 化学结构N-nitroso-tranexamic-acid dimer(trans,trans)-4,4'-((Nitrosoazanediyl)bis (methylene))bis(cyclohexane-1-carboxylic acid)OC(=O)C2CCC(CN(CC1CCC(CC1)C(=O)O)N=O)CC2NATranexamic acid4150001 October 2026 (new)
N-nitrosamines A261 化学结构N-nitroso-trientine impurity 1N-(2-aminoethyl)-N-(2-((2-aminoethyl)amino)ethyl)nitrous amideN(CCN)CCN(CCN)N=ONATrientine1182024-05-01
N-nitrosamines A262 化学结构N-nitroso-trimetazidine1-nitroso-4-[(2,3,4-trimethoxyphenyl)methyl]piperazineCOC1=C(C(=C(C=C1)CN2CCN(CC2)N=O)OC)OC92432-50-3NTMZTrimetazidine13000Limit based on the BMDL10 for the most sensitive tissue and gender from a robust rat carcinogenicity study conducted with NTMZ. Nitrosamine with sufficiently robust toxicological data to serve as point of departure for derivation of other AIs by SAR and read-across.2023-07-01
N-nitrosamines A263 化学结构N-nitroso-urapidilN-(1, 3-Dimethyl-2, 6-dioxo-1, 2, 3, 6-tetrahydropyrimidin-4-yl)-N-(3-(4-(2-methoxyphenyl)piperazin-1-yl)propyl)nitrous amideCN1C(=CC(=O)N(C1=O)C)N(CCCN2CCN(CC2)C3=CC=CC=C3OC)N=ONAUrapidil415002024-01-15
N-nitrosamines A264 化学结构N-nitroso-valsartan cyano-desvalerylmethylester(S)-Methyl 2-(((2'-cyano-[1,1'-biphenyl]-4-yl)methyl)(nitroso)amino)-3-methylbutanoateCC(C)[C@@H](C(=O)OC)N(CC1=CC=C(C=C1)C2=CC=CC=C2C#N)N=ONAValsartan21002024-09-01
N-nitrosamines A265 化学结构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 acidClC3=C4OC=5C(O[C@@]2(O[C@@]([C@@](O[H])([C@](O[H])([C@]2(O[C@@]1(O[C@]([C@@](O[H])([C@](N([H])[H])(C1([H])[H])C([H])([H])[H])[H])(C([H])([H])[H])[H])[H])[H])[H])[H])(C(O[H])([H])[H])[H])[H])=C6OC%10=C(Cl)C(=C([C@](O[H])([C@@]7(N(C(=O)[C@](N(C(=O)[C@](N(C(=O)[C@](N(C(=O)[C@](N(C(=O)[C@](N(N=O)C([H])([H])[H])(C(C(C([H])([H])[H])(C([H])([H])[H])[H])([H])[H])[H])[H])([C@@](O[H])(C(=C3[H])C(=C4[H])[H])[H])[H])[H])(C(C(=O)N([H])[H])([H])[H])[H])[H])(C(C=5[H])=C6[H])[H])[H])(C9=C(C(C8=C([C@@](N(C7=O)[H])(C(O[H])=O)[H])C(=C(O[H])C(=C8O[H])[H])[H])=C(O[H])C(=C9[H])[H])[H])[H])[H])[H])[H])C(=C%10[H])[H])[H]NAVancomycinNMILimit derived using structure-activity-relationship, physicochemical features and weight of evidence approach for N-nitroso-vancomycin based on N-nitroso-desmethyl-azithromycin and N-nitroso-desmethyl-clarithromycin as surrogates. Can be controlled according to ICH Q3A/B2025-02-01
N-nitrosamines A266 化学结构N-nitroso-vanzacaftor(14S)-8-[3-(2-dispiro[2.0.24.13]heptan-7-ylethoxy)pyrazol-1-yl]-12,12-dimethyl-2,2-dioxo-2λ6-thia-18-nitroso-3,9,11,18,23-pentazatetracyclo [17.3.1.111,14.05,10] tetracosa-1(22),5(10),6,8,19(23),20-hexaen-4-oneC3=4S(=O)(NC(=O)C1=CC=C(N=C1N2C[C@@H](CC2(C)C)CCCN(C(=CC=C3)N=4)N=O)N5C=CC(=N5)OCCC7C6(CC6)C78CC8)=ONAVanzacaftor41500CPCA was derived using a correction to account for the 5-carbon chain length feature2024-09-01
N-nitrosamines A267 化学结构N-nitroso-varenicline(1R,12S)-14-nitroso-5,8,14-triazatetracyclo[10.3.1.02,11.04,9]hexadeca-2,4,6,8,10-pentaeneC1C2CN(CC1C3=CC4=NC=CN=C4C=C23)N=O2755871-02-2NNVVarenicline34002021-09-01
N-nitrosamines A268 化学结构N-nitroso-venlafaxine EP Impurity DN-(2-(1-Hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-methylnitrous amideCOC2=CC=C(C(C1(O)CCCCC1)CN(C)N=O)C=C22680662-11-5Venlafaxine1182025-08-01
N-nitrosamines A269 化学结构N-nitroso-venlafaxine EP Impurity HN-(2-(1-Hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-(4-methoxyphenethyl)nitrous amideCOC3=CC=C(C(C1(O)CCCCC1)CN(N=O)CCC2=CC=C(OC)C=C2)C=C3NAVenlafaxine21002025-08-01
N-nitrosamines A270 化学结构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-carboxamideO=C(Nc3ccc(C[C@@H]2CC[C@H]([C@H](O)c1ccccc1)N2N=O)cc3)[C@@H]4CCc5nccc(=O)n45NAVibegron515002024-05-01
N-nitrosamines A271 化学结构N-nitroso-vildagliptinN-(2-((S)-2-cyanopyrrolidin-1-yl)-2-oxoethyl)-N-((1r,3R,5R,7S)-3-hydroxyadamantan-1-yl)nitrous amideO=C(N(CCC1)[C@@H]1C#N)CN(N=O)[C@](C[C@H](C2)C3)(C[C@@H]2C4)C[C@]34ONAVildagliptin515002023-07-01
N-nitrosamines A272 化学结构N-nitroso-vildagliptin amide impurity(S)-1-(2-(((1r, 3R, 5R, 7S)-3-hydroxyadamantan-1-yl)(nitroso)amino)acetyl)pyrrolidine-2-carboxamide(S)-1-(2-(((1r, 3R, 5R, 7S)-3-hydroxyadamantan-1-yl)(nitroso)amino)acetyl)pyrrolidine-2-carboxamide[C@]12(C[C@@](C[C@](C1)([H])C)(CC(C2)(O)C)[H])N(N=O)CC(N3CCC[C@H]3C(N)=O)=ONAVildagliptin515002024-09-01
N-nitrosamines A273 化学结构N-nitroso-vortioxetine1-[2-(2,4-dimethylphenyl)sulfanylphenyl]-4-nitrosopiperazineCC1=CC(=C(C=C1)SC2=CC=CC=C2N3CCN(CC3)N=O)CNAVortioxetine34002023-07-01
N-nitrosamines A274 化学结构Rivaroxaban nitroso impurity 1N-(2-hydroxyethyl)-N-phenyl-nitrous amideC1=CC=CC=C1N(CCO)N=O25413-76-7N-Nitroso KCR-1Rivaroxaban415002024-05-01
N-nitrosamines A275 化学结构Rivaroxaban nitroso impurity 2N-(3-(1,3-dioxoisoindolin-2-yl)-2-hydroxypropyl)-N-(4-(3-oxomorpholino) phenyl)nitrous amideC1COCC(=O)N1C2=CC=C(C=C2)N(CC(CN3C(C4=C(C3=O)C=CC=C4)=O)O)N=ONARivaroxaban415002024-05-01
N-nitrosamines A276 化学结构Rivaroxaban nitroso impurity 5N-(3-Chloro-2-hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)nitrous amideC1(=CC=C(C=C1)N(CC(CCl)O)N=O)N2CCOCC2=ONAN-Nitroso RVR-ARivaroxaban415002024-05-01

Other N-nitroso-structures

2026-10-01

EMA/CHMP/219920/2026/Rev. 14

Non-clincal Working Party (NcWP)

Acceptable intakes (AIs) established for N-nitroso-structures other than N-nitrosamines

The below acceptable intake levels (AIs) have been established by the Non-clinical Working Party (NcWP).
These limits apply only when a finished product (FP) contains a single N-nitroso compound.
The listed source indicates a potential association with the named active pharmaceutical ingredient (API) or its related impurities; it does not imply that the N-nitroso impurity is present in every product or pharmaceutical form containing that API. Please refer to Q&A on the risk factors for the presence of N-nitroso-structures for further details.

StructureNameIUPAC nameSMILESCAS RNSynonym/ AcronymSourceAI (ng/day)NotePublication date
Other N-nitroso-structures A20 化学结构N-nitroso-biotin5-[(3aR,6S,6aS)-3-nitroso-2-oxo-3a,4,6,6a-tetrahydro-1H-thieno[3,4-d]imidazol-6-yl]pentanoic acidC1[C@H]2[C@@H]([C@@H](S1)CCCCC(=O)O)NC(=O)N2N=O56859-26-8D-biotin1500Limit based on negative bacterial reverse mutation test.2024-12-01
Other N-nitroso-structures A21 化学结构N-nitroso-cimetidine3-cyano-1-methyl-2-[2-[(5-methyl-1H-imidazol-4-yl)methylsulfanyl]ethyl]-1-nitrosoguanidineCC1=C(N=CN1)CSCCN=C(NC#N)N(C)N=O73785-40-7Cimetidine553Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of MNNG as point of departure. 2024-12-01
Other N-nitroso-structures A22 化学结构N-nitroso-clonidineN-(2,6-dichlorophenyl)-1-nitroso-4,5-dihydroimidazol-2-amineC1CN(C(=N1)NC2=C(C=CC=C2Cl)Cl)N=O148950-49-6Clonidine553Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of MNNG as point of departure. 2024-12-01
Other N-nitroso-structures A23 化学结构N-nitroso-eletriptan (S)-3-((1-methylpyrrolidin-2-yl)methyl)-1-nitroso-5-(2-(phenylsulfonyl)ethyl)-1H-indoleO=S(C1=CC=CC=C1)(CCC4=CC=3C(CC2CCCN2C)=CN(N=O)C=3C=C4)=ONAEletriptan1500Limit derived using structure-activity-relationship, physicochemical features and weight of evidence for N-nitroso-indoles based on C- nitro and C-nitroso-aromatic compounds.2024-12-01
Other N-nitroso-structures A24 化学结构N-nitroso-melatoninN-[2-(5-methoxy-1-nitrosoindol-3-yl)ethyl]acetamideCC(=O)NCCC1=CN(C2=C1C=C(C=C2)OC)N=O278783-22-5Melatonin1500Limit derived using structure-activity-relationship, physicochemical features and weight of evidence for N-nitroso-indoles based on C- nitro and C-nitroso-aromatic compounds.2024-12-01
Other N-nitroso-structures A25 化学结构N-methyl-N’-nitro-N-nitrosoguanidine1-methyl-3-nitro-1-nitrosoguanidineCN(C(=N)N[N+](=O)[O-])N=O70-25-7MNNG553Limit based on the most sensitive TD50 derived from the most robust TD50 dataset from carcinogenic potency database (CPDB) or Lhasa Carcinogenicity Database (LCDB version 2023.1). N-nitroso-guanidine with sufficiently robust toxicological data to serve as points of departure for derivation of other AIs by SAR and read-across. 2024-12-01
Other N-nitroso-structures A26 化学结构1-Nitroso-moxonidine Impurity 7 4-chloro-6-methoxy-2-methyl-3-(1-nitroso-4,5-dihydroimidazol-2-yl)-4H-pyrimidin-5-amineCC1=NC(=C(C(N1C2=NCCN2N=O)Cl)N)OCNAMoxonidine 553Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of MNNG as point of departure. 2024-12-01
Other N-nitroso-structures A27 化学结构1-Nitroso-moxonidineN-(4-chloro-6-methoxy-2-methylpyrimidin-5-yl)-N-(4,5-dihydro-1H-imidazol-2-yl)nitrous amideCC1=NC(=C(C(=N1)Cl)N(C2=NCCN2)N=O)OCNAMoxonidine 553Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of MNNG as point of departure. 2024-12-01
Other N-nitroso-structures A28 化学结构N-nitroso-naratriptanN-methyl-2-[3-(1-methylpiperidin-4-yl)-1-nitrosoindol-5-yl]ethanesulfonamideCNS(=O)(=O)CCC1=CC2=C(C=C1)N(C=C2C3CCN(CC3)C)N=O1216880-64-6
Naratriptan1500Limit derived using structure-activity-relationship, physicochemical features and weight of evidence for N-nitroso-indoles based on C- nitro and C-nitroso-aromatic compounds.2024-12-01
Other N-nitroso-structures A29 化学结构N-nitroso-rizatriptanN,N-dimethyl-2-[1-nitroso-5-(1,2,4-triazol-1-ylmethyl)indol-3-yl]ethanamineCN(C)CCC1=CN(C2=C1C=C(C=C2)CN3C=NC=N3)N=ONARizatriptan1500Limit derived using structure-activity-relationship, physicochemical features and weight of evidence for N-nitroso-indoles based on C- nitro and C-nitroso-aromatic compounds.2024-12-01
Other N-nitroso-structures A30 化学结构N-nitroso-sumatriptan1-[3-[2-(dimethylamino)ethyl]-1-nitrosoindol-5-yl]-N-methylmethanesulfonamideCNS(=O)(=O)CC1=CC2=C(C=C1)N(C=C2CCN(C)C)N=ONASumatriptan1500Limit derived using structure-activity-relationship, physicochemical features and weight of evidence for N-nitroso-indoles based on C- nitro and C-nitroso-aromatic compounds.2024-12-01
Other N-nitroso-structures A31 化学结构N-nitroso-tadalafil(2,8)-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-dioneCN1CC(=O)N2C(C1=O)CC5=C(C2C3=CC4=C(C=C3)OCO4)N(C6=CC=CC=C56)N=ONATadalafil1500Limit derived using structure-activity-relationship, physicochemical features and weight of evidence for N-nitroso-indoles based on C- nitro and C-nitroso-aromatic compounds.2024-12-01
Other N-nitroso-structures A32 化学结构N-nitroso-tizanidineN-(5-chloro-2,1,3-benzothiadiazol-4-yl)-N-(4,5-dihydro-1H-imidazol-2-yl)nitrous amideC1CN=C(N1)N(C2=C(C=CC3=NSN=C32)Cl)N=ONATizanidine553Limit derived using structure-activity-relationship (SAR)/read-across approach using the TD50 of MNNG as point of departure. 2024-12-01
Other N-nitroso-structures A33 化学结构N-nitroso-tryptophol2-(1-nitro+B36C36:I36+C36:H36+C36+C36:I36C1=CC=C2C(=C1)C(=CN2N=O)CCO120314-14-9Tryptophol1500Limit derived using structure-activity-relationship, physicochemical features and weight of evidence for N-nitroso-indoles based on C- nitro and C-nitroso-aromatic compounds.2024-12-01
Other N-nitroso-structures A34 化学结构N-nitroso-xylometazoline2-(4-(tert-butyl)-2,6-dimethylbenzyl)-1-nitroso-4,5-dihydro-1H-imidazoleN/1(CC\N=C/1CC2=C(C)C=C(C(C)(C)C)C=C2C)N=OXylometazoline18In the absence of a suitable surrogate or specific carcinogenicity data for amidine-containing molecules the limit of 18 ng/day is based on the substance specific TTC as that dataset included “other nitroso” structures.01 October 2026 (new)
Other N-nitroso-structures A35 化学结构N-nitroso-zolmitriptan(4S)-4-[[3-[2-(dimethylamino)ethyl]-1-nitrosoindol-5-yl]methyl]-1,3-oxazolidin-2-oneCN(C)CCC1=CN(C2=C1C=C(C=C2)C[C@H]3COC(=O)N3)N=ONAZolmitriptan1500Limit derived using structure-activity-relationship, physicochemical features and weight of evidence for N-nitroso-indoles based on C- nitro and C-nitroso-aromatic compounds.2024-12-01

来源：EMA 亚硝胺指南与技术附件 · ema.europa.eu

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