2025年3月最新发布：TGA发布亚硝胺杂质限度-化学分析百科|合成百科|实验室咨询

2025年3月最新发布：TGA发布亚硝胺杂质限度

来源：本站 2025-03-09

导读：亚硝胺英文来源药物名称AI值（ng/day)CPCA潜在分类发表日期N-Methyl-N-nitrosophenethylamine(13256-11-6, NMPEA)-N-甲基-N-亚硝基甲胺85-Jan-233-((Ethyl(nitroso)amino)methyl) benzenesulfonateDextromethorphan右美沙芬18129-Jul-24N-Nitroso-2,4-thiazole amine /N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous

亚硝胺	英文	来源药物名称	AI值（ng/day)	CPCA潜在分类	发表日期
N-Methyl-N-nitrosophenethylamine(13256-11-6, NMPEA)	-	N-甲基-N-亚硝基甲胺	8		5-Jan-23
3-((Ethyl(nitroso)amino)methyl) benzenesulfonate	Dextromethorphan	右美沙芬	18	1	29-Jul-24
N-Nitroso-2,4-thiazole amine /N-((2-isopropylthiazol-4-yl)methyl)-N-methylnitrous amide	Ritonavir	利托那韦	18	1	15-Oct-24
N-Nitroso-betahistine(32635-81-7)	Betahistine	倍他司汀	18	1	24-Aug-23
N-Nitroso-desmethyl sumatriptan	Sumatriptan	舒马普坦	18	1	31-Jan-24
N-Nitroso-desmethyl-chloropyramine(N-DMCP)	Chloropyramine	氯吡胺	18	1	24-Aug-23
N-Nitroso-desmethyl-chlorphenamine /	Chlorphenamine	氯苯那敏	18	1	4-Feb-25
N-Nitroso-desmethyl-dimetindene /	Dimetindene	二甲茚定	18	1	15-Oct-24
N-Nitroso-desmethyl-galantamine /	Galantamine	加兰他敏	18	1	4-Feb-25
N-Nitroso-desmethyl-tamoxifen /	Tamoxifen	他莫昔芬	18	1	24-Apr-24
N-Nitroso-desmethyl-terbinafine /	Terbinafine	特比萘芬	18	1	31-Jan-24
N-Nitroso-desmethyl-tramadol /	Tramadol	曲马多	18	1	29-Jul-24
N-Nitroso-desmethyl-tripelennamine	Tripelennamine	三苯乙胺	18	1	24-Aug-23
N-Nitroso-desvenlafaxine	Desvenlafaxine	地文拉法辛	18	1	31-Jan-24
N-Nitroso-maprotiline /	Maprotiline	马普替林	18	1	15-Oct-24
N-Nitroso-N-desmethyl-diphenhydramine /	Diphenhydramine / Dimenhydrinate	苯海拉明/茶苯海明	18	1	29-Jul-24
N-Nitroso-N-desmethyl-rizatriptan /	Rizatriptan	利扎曲坦	18	1	15-Oct-24
N-Nitroso-N-ethyl-benzylamine /	-	N-亚硝基-N-乙基苄胺/	18	1	29-Jul-24
N-Nitroso-nortriptyline	Amitriptyline, Nortriptyline	阿米替林、去甲替林	18	1	20-Jul-22
N-Nitroso-orphenadrine	Orphenadrine	奥芬那君	18	1	24-Aug-23
N-Nitroso-terbinafine degradant	Terbinafine	特比萘芬	18	1	31-Jan-24
N-Nitroso-terbinafine impurity A	Terbinafine	特比萘芬	18	1	31-Jan-24
N-Nitroso-trientine Impurity 1 /	Trientine	曲恩汀	18	1	29-Jul-24
N‐Nitroso‐desmethyl‐zolmitriptan /	Zolmitriptan	佐米曲坦	18	1	4-Feb-25
N-Nitroso-di-n-butylamine(924-16-3, NDBA)	-	N-亚硝基-2-丁胺	26.5		20-Jul-22
N-Nitroso-diethylamine(55-18-5, NDEA)	-	N-亚硝基-2-乙胺	26.5		15-Sep-19
N-Nitroso-dipropylamine(621-64-7, NDPA)	-	N-亚硝基二丙胺	26.5		20-Jul-22
N-Nitroso-1,2,3,6-tetrahydropyridine(55556-92-8, NTHP)	-	N-亚硝基-1,2,3,6-四氢吡啶	37		20-Jul-22
N-Nitroso-dimethylamine(62-75-9, NDMA)	-	NDMA	96		15-Sep-19
4-(Methylnitrosoamino)-1-(3-pyridinyl)-1-butanone(64091-91-4, NNK)		-	100		5-Jan-23
7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3-a]pyrazine(2892260-32-9, NTTP)	Sitagliptin	磷酸西他列汀	100	2	Updated 29 July 2024
N-Nitroso-2-(7-methoxy-1-naphthyl)-N-[2-(7-methoxy-1-naphthyl)ethyl]ethylamine	Agomelatine	阿戈美拉汀	100	2	29-Jul-24
N-Nitroso-atomoxetine	Atomoxetine	托莫西汀	100		24-Aug-23
N-Nitroso-desethyllidocaine	Lidocaine / Lignocaine	利多卡因/利多卡因	100	2	31-Jan-24
N-Nitroso-desformyl-riociguat /	Riociguat	瑞奥西呱	100	2	29-Jul-24
N-Nitroso-desmethyl-azelastine	Azelastine	氮卓斯汀	100	2	31-Jan-24
N-Nitroso-desmethyl-citalopram /	Citalopram	西酞普兰	100		31-Jan-24
N-Nitroso-desmethyl-edoxaban /	Edoxaban	依杜沙班	100	2	29-Jul-24
N-Nitroso-desmethyl-rivastigmine /	Rivastigmine	利瓦斯汀	100	2	15-Oct-24
N-Nitroso-didecylamine	Colesevelam	考来维仑	100	2	4-Feb-25
N-Nitroso-duloxetine(2680527-91-5, NDLX)	Duloxetine	度洛西汀	100		20-Jul-22
N-Nitroso-epinephrine /N-nitroso-adrenaline	Epinephrine / Adrenaline	肾上腺素/肾上腺素	100	2	4-Feb-25
N-Nitroso-N-methylaniline /	-	N-亚硝基-N-甲基苯胺	100	2	31-Jan-24
N-Nitroso-nornicotine /	Nicotine	尼古丁	100		4-Feb-25
N-Nitroso-p-chloro-benzylamino-pyridine	Chloropyramine	氯吡胺	100	2	24-Aug-23
N-Nitroso-phenylephrine	Phenylephrine	苯肾上腺素	100	2	24-Aug-23
N-Nitroso-propafenon /	Propafenon	心律平	100	2	15-Oct-24
N-Nitroso-sertraline	Sertraline	舍曲林	100	2	24-Aug-23
N-Nitroso-valsartan cyano-desvalerylmethylester /	Valsartan	缬沙坦	100	2	15-Oct-24
N-Nitrosofluoxetine	Fluoxetine	氟西汀	100		5-Jan-23
N-Nitrosorasagiline	Rasagiline	雷沙吉兰	100	2	20-Jul-22
N-Nitroso-morpholine	-	N-亚硝基吗啉	127		20-Jul-22
N-Nitroso-reboxetine	Reboxetine	瑞波西汀	127		24-Aug-23
1-(2,3-Dichlorophenyl)-4-nitrosopiperazine (2221987-86-4)	Aripiprazole	阿立哌唑	400	3	31-Jan-24
1-(Diphenylmethyl)-4-nitrosopiperazine /1-benzhydryl-4-nitrosopiperazine (1698-25-5)	Cinnarizine	桂利嗪	400	3	29-Jul-24
1-Methyl-4-nitrosopiperazine (16339-07-4, MeNP/MNP)	Rifampicin	利福平	400	3	Updated 24 August 2023
2-(4-Nitrosopiperazin-1-yl)ethanol(48121-20-6)	Opipramol	奥匹哌醇	400	3	29-Jul-24
3-(Dimethylamino)propyl 2-[benzyl(nitroso)amino]benzoate	Benzydamine	苄达明	400	3	29-Jul-24
3-Amino-N-nitrosopiperidine(2819242-71-0)	Alogliptin	阿格列汀	400	3	16-Oct-23
4-Nitroso-methyl piperazine-1-carboxylate(N-nitroso PMEC)	Omecamtiv mecarbil	奥美拉唑	400	3	29-Jul-24
N-(2-Hydroxy-2-phenylethyl)-N-(4-nitrophenethyl)nitrous amide /	Mirabegron	米拉贝隆	400	3	29-Jul-24
N-(4-Aminophenethyl)-N-(2-hydroxy-2-phenylethyl)nitrous amide /	Mirabegron	米拉贝隆	400	3	29-Jul-24
N-Nitroso derivative of rotigotine impurity B /N-(5-hydroxy-1,2,3,4-tetrahydronaphthalen-2-yl)-N-propylnitrous amide	Rotigotine	罗替戈汀	400	3	16-Oct-23
N-Nitroso desmethyl nintedanib	Nintedanib	尼达尼布	400	3	31-Jan-24
N-nitroso ranolazine impurity 1 /	Ranolazine	雷诺嗪	400	3	31-Jan-24
N-Nitroso terazosin impurity C /	Terazosin	特拉唑嗪	400	3	24-Apr-24
N-Nitroso terazosin impurity N /(2470438-57-2)	Terazosin	特拉唑嗪	400	3	24-Apr-24
N--Nitroso-aryl piperazine / N-nitroso-desalkylquetiapine	Quetiapine	奎硫平	400	3	24-Aug-23
N-Nitroso-azacyclonol(1038-06-8)	Azacyclonol	氮杂环醇	400	3	31-Jan-24
N-Nitroso-bilastine impurity 2 /	Bilastine	比拉斯汀	400	3	29-Jul-24
N-Nitroso-buspirone Impurity 1 /	Buspirone	丁螺环酮	400	3	15-Oct-24
N-Nitroso-cinacalcet	Cinacalcet	西那卡塞	400	3	31-Jan-24
N-Nitroso-clozapine EP Impurity C /	Clozapine	氯氮平	400	3	24-Apr-24
N-Nitroso-desloratadine(1246819-22-6)	Desloratadine	地氯雷他定	400	3	24-Aug-23
N-Nitroso-desmethyl-sildenafil	Sildenafil	西地那非	400	3	31-Jan-24
N-Nitroso-ethylisopropylamine /(16339-04-1, EIPNA/NEIPA)	-		400	3	Updated 29 July 2024
N-Nitroso-fenfluramine /(19023-40-6)	Fenfluramine	芬氟拉明	400	3	29-Jul-24
N-Nitroso-landiolol	Landiolol	兰地洛尔	400	3	24-Aug-23
N-Nitroso-masitinib /	Masitinib	马西替尼	400	3	24-Apr-24
N-Nitroso-mirabegron	Mirabegron	米拉贝隆	400	3	24-Aug-23
N-Nitroso-mirtazapine	Mirtazapine	米氮平	400	3	31-Jan-24
N-Nitroso-N-deshydroxyethyl-dasatinib	Dasatinib	达沙替尼	400	3	4-Feb-25
N-Nitroso-N-ethyl-valaciclovir	Valaciclovir	伐昔洛韦	400	3	24-Aug-23
N-Nitroso-N-methyl-valaciclovir	Valaciclovir	伐昔洛韦	400	3	24-Apr-24
N-Nitroso-piperazine	-		400	3	24-Aug-23
N-Nitroso-posaconazole Impurity 1 /	Posaconazole	泊沙康唑	400	3	29-Jul-24
N-Nitroso-pramipexole	Pramipexole	普拉克索	400	3	24-Aug-23
N-Nitroso-ribociclib impurity 1 /	Ribociclib	核糖胞苷	400	3	31-Jan-24
N-Nitroso-tetracaine	Tetracaine	丁卡因	400	3	31-Jan-24
N-Nitroso-trimetazidine	Trimetazidine	曲美他嗪	400	3	24-Aug-23
N-Nitroso-varenicline	Varenicline	伐尼克兰	400	3	20-Jul-22
N-Nitroso-vortioxetine	Vortioxetine	沃替西汀	400	3	24-Aug-23
N-Nitrosodiisopropanolamine /	-		400	3	24-Apr-24
Nitroso impurity C” [N-(2,6-dimethylphenyl)-2-(4-nitrosopiperazin-1-yl)acetamide]	Ranolazine	雷诺嗪	400	3	24-Aug-23
N-Nitroso-methylphenidate	Methylphenidate	哌甲酯	1300		20-Jul-22
N-Nitroso-paroxetine	Paroxetine	帕罗西汀	1300		5-Jan-23
N-Nitrosopiperidine	-	-	1300		20-Jul-22
1-Nitroso-pyrrolopiperidine	-	-	1500	4	24-Aug-23
2,2,5-Trimethyl-3-nitroso-1,3-oxazolidine (77400-46-5, TMNO)	Cyanocobalamine	氰钴胺	1500	4	24-Apr-24
5-Chloro-4-methyl-2-[(2S)-2-methyl-1-nitrosopyrrolidin-2-yl]-1H-benzimidazole	Daridorexant	Daridorexat	1500	5	31-Jan-24
Indapamide impurity A /2-methyl-1-nitroso-2,3-dihydroindole	Indapamide	吲达帕胺	1500	5	31-Jan-24
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	罗替戈汀	1500	4	16-Oct-23
N-Nitroso imatinib	Imatinib	伊马替尼	1500	5	31-Jan-24
N-Nitroso quetiapine HEEP impurity /	Quetiapine	奎硫平	1500		31-Jan-24
N-Nitroso vildagliptin amide impurity /	Vildagliptin	维格列汀	1500	5	15-Oct-24
N-Nitroso-2,6-pipecoloxilidide	Ropivacaine	罗哌卡因	1500	4	24-Aug-23
N-Nitroso-acebutolol	Acebutolol	醋丁洛尔	1500	4	15-Oct-24
N-Nitroso-ambroxol	Ambroxol	氨溴索	1500		24-Aug-23
N-Nitroso-anabasine /(37620-20-5, NAB)	Nicotine	尼古丁	1500	4	4-Feb-25
N-Nitroso-anatabine /(71267-22-6, NAT)	Nicotine	尼古丁	1500	4	4-Feb-25
N-Nitroso-apixaban impurity B /	Apixaban	阿哌沙班	1500	4	24-Apr-24
N-Nitroso-articaine /	Articaine	阿替卡因	1500	4	29-Jul-24
N-Nitroso-atenolol(134720-04-0)	Atenolol	阿替洛尔	1500	4	24-Aug-23
N-Nitroso-benazepril	Benazepril	苯那普利	1500	5	24-Aug-23
N-Nitroso-betaxolol	Betaxolol	倍他洛尔	1500	4	31-Jan-24
N-Nitroso-bisoprolol(2820170-76-9, NBP)	Bisoprolol	比索洛尔	1500	4	24-Aug-23
N-Nitroso-bumetanide(2490432-02-3, NNB)	Bumetanide	布美他尼	1500	4	24-Aug-23
N-Nitroso-caspofungin /	Caspofungin	卡泊芬净	1500	4	29-Jul-24
N-Nitroso-celiprolol	Celiprolol	塞利路尔	1500	5	31-Jan-24
N-Nitroso-cilazapril(1053740-92-3)	Cilazapril	西拉普利	1500	5	24-Aug-23
N-Nitroso-clozapine /(156632-03-0)	Clozapine	氯氮平	1500	5	24-Apr-24
N-Nitroso-dabigatran etexilate(NDAB)	Dabigatran etexilate	达比加群酯	1500		5 January 2023 Updated 24 August 2023 and 24 April 2024
N-Nitroso-desmethyltrimebutine	Trimebutine	曲美布汀	1500	5	24-Aug-23
N-Nitroso-desmethyl-eletriptan /	Eletriptan	依来曲普坦	1500	4	4-Feb-25
N-Nitroso-diisopropylamine /(601-77-4, DIPNA/NDIPA)	-	-	1500	5	15-Sep-19
N-Nitroso-dorzolamide	Dorzolamide	多佐胺	1500		31-Jan-24
N-Nitroso-enalapril	Enalapril	依那普利	1500	5	24-Aug-23
N-Nitroso-esmolol	Esmolol	艾司洛尔	1500	4	31-Jan-24
N-Nitroso-ethylenediamine-triacetic acid(862542-34-5)	Isosorbide mononitrate	单硝酸异山梨酯	1500	4	31-Jan-24
N-Nitroso-felodipine	Felodipine	非洛地平	1500	5	24-Aug-23
N-Nitroso-flecainide /(2901109-58-6)	Flecainide	氟卡尼	1500	4	24-Apr-24
N-Nitroso-folic acid /(26360-21-4, NFA)	Folic acid	叶酸	1500	4	24-Aug-23
N-Nitroso-furosemide /(2708280-93-5)	Furosemide	呋塞米	1500		29-Jul-24
N-Nitroso-iminodiacetic acid(25081-31-6)	Isosorbide mononitrate	单硝酸异山梨酯	1500	4	31-Jan-24
N-Nitroso-ketamine /	Ketamine	氯胺酮	1500	5	24-Aug-23
N-Nitroso-L-prolinamide /(79108-51-3)	Vildagliptin	维格列汀	1500	4	4-Feb-25
N-Nitroso-L-prolinenitrile /	Vildagliptin	维格列汀	1500	4	4-Feb-25
N-Nitroso-labetalol(2820170-74-7)	Labetalol	拉贝洛尔	1500	4	24-Aug-23
N-Nitroso-leniolisib	Leniolisib	Leniolisib	1500	5	31-Jan-24
N-Nitroso-levofloxacin	Levofloxacin	左氧氟沙星	1500	4	24-Aug-23
N-Nitroso-meropenem /	Meropenem	美罗培南	1500	4	24-Apr-24
N-Nitroso-metoprolol	Metoprolol	美托洛尔	1500	4	24-Aug-23
N-Nitroso-moxifloxacin	Moxifloxacin	莫西沙星	1500	4	24-Aug-23
N-Nitroso-N-desmethyl dextromethorphan/	Dextromethorphan	右美沙芬	1500	4	29-Jul-24
N-Nitroso-N-methyl-4-aminobutyric acid /	-		1500	4	15-Sep-19
N-Nitroso-nebivolol	Nebivolol	奈必洛尔	1500	4	24-Aug-23
N-Nitroso-nilotinib /	Nilotinib	尼洛替尼	1500	5	4-Feb-25
N-Nitroso-nor-oxycodone /	Nalmefene	纳美芬	1500	4	4-Feb-25
N-Nitroso-perindopril	Perindopril	培哚普利	1500	5	24-Aug-23
N-Nitroso-praziquanamine /	Arpraziquantel	阿帕唑酮	1500	4	24-Aug-23
N-Nitroso-propranolol	Propranolol	普萘洛尔	1500	4	24-Aug-23
N-Nitroso-pseudoephedrine	Pseudoephedrine	伪麻黄碱	1500	4	24-Aug-23
N-Nitroso-ramipril	Ramipril	雷米普利	1500	5	24-Aug-23
N-Nitroso-ritalinic acid /	Methylphenidate	哌甲酯	1500	4	24-Apr-24
N-Nitroso-rivaroxaban amide /	Rivaroxaban	利伐沙班	1500	4	31-Jan-24
N-Nitroso-rivaroxaban open-ring acid	Rivaroxaban	利伐沙班	1500	4	31-Jan-24
N-Nitroso-salbutamol	Salbutamol	沙丁胺醇	1500	5	24-Aug-23
N-Nitroso-silodosin /	Silodosin	西洛多辛	1500	4	24-Apr-24
N-Nitroso-sotalol	Sotalol	索他洛尔	1500	4	24-Aug-23
N-Nitroso-tamsulosin	Tamsulosin	坦索罗辛	1500	4	20-Jul-22
N-Nitroso-trandolapril /	Trandolapril	特拉多普利	1500	5	29-Jul-24
N-Nitroso-urapidil	Urapidil	乌拉地尔	1500	4	31-Jan-24
N-Nitroso-vanzacaftor /	Vanzacaftor	万扎卡福	1500	4	15-Oct-24
N-Nitroso-vibegron	Vibegron	维贝格罗	1500	5	29-Jul-24
N-Nitroso-vildagliptin	Vildagliptin	维格列汀	1500	5	24-Aug-23
N‐Nitroso‐ticagrelor	Ticagrelor	替卡格雷	1500	5	31-Jan-24
Rivaroxaban Nitroso Impurity 1 /	Rivaroxaban	利伐沙班	1500	4	29-Jul-24
Rivaroxaban Nitroso Impurity 2 /	Rivaroxaban	利伐沙班	1500	4	29-Jul-24
Rivaroxaban Nitroso Impurity 5 /	Rivaroxaban	利伐沙班	1500	4	29-Jul-24
2-Nitroso-octahydrocyclopenta(c)pyrrole(54786-86-6)	Gliclazide	格列齐特	1700		24-Aug-23
N-Nitroso-pyrrolidine	-		1700		5-Jan-23
N-Nitroso-diethanolamine(1116-54-7, NDELA)	-	-	1900		5-Jan-23
N-Nitroso-diclofenac(66505-80-4)	Diclofenac	双氯芬酸	78000		24-Aug-23
N-Nitroso-diphenylamine(86-30-6, NDPh)	-	-	78000		5-Jan-23
N-Nitroso-iminodibenzyl /(7458-08-4)	Melipramin (Imipramine)	美利普明（丙咪嗪）	78000		15-Oct-24
N-Nitroso-mefenamic acid	Mefenamic acid	甲芬那酸	78000		5-Jan-23
N-Nitroso-azithromycin	Azithromycin	阿奇霉素	NMI		24-Aug-23
N-Nitroso-bupropion /(2763780-10-3)	Bupropion	安非他酮	NMI		24-Aug-23
N-Nitroso-calcium folinate	Calcium folinate / Calcium levofolinate	亚叶酸钙/左亚叶酸钙	NMI		31-Jan-24
N-Nitroso-ciprofloxacin(864443-44-7)	Ciprofloxacin	环丙沙星	NMI		24-Aug-23
N-Nitroso-desmethylazithromycin	Azithromycin	阿奇霉素	NMI		24-Aug-23
N-Nitroso-desvaleryl-valsartan /	Valsartan	缬沙坦	NMI		29-Jul-24
N-Nitroso-hydrochlorothiazide(63779-86-2, NHCTZ)	Hydrochlorothiazide	氢氯噻嗪	NMI		24-Aug-23
N-Nitroso-lisinopril /	Lisinopril	赖诺普利	NMI		24-Aug-23
N-Nitroso-N-desmethyl-clarithromycin /	Clarithromycin	克拉霉素	NMI		29-Jul-24
N-Nitroso-quinapril	Quinapril	喹那普利	NMI		24-Aug-23
N-Nitroso-tigecycline /	Tigecycline	替加环素	NMI		29-Jul-24

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established-acceptable-intake-for-nitrosamines-in-medicines-table-images.pdf

TAG标签：亚硝胺、杂质限度

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