Nitrosamine Impurities

Sr. No. Impurity name CAS No. Chemical structure
1 N-Nitrosomorpholine 59-89-2
2 N-Nitrosodiethanolamine 1116-54-7
3 N-Nitrosodimethylamine (NDMA) 62-75-9
4 N- Nitrosodiethylamine 55-18-5
5 N - Nitrosomethylphenylamine 614-00-6
6 N- Nitrosodiisopropylamine 601-77-4
7 N- Nitrosoisopropylethylamine 16339-04-1
8 N- Nitrosodibutylamine 924-16-3
9 N-Nitroso-N-Methyl - 4 - amino butyric acid 61445-55-4
10 Nitroso Sitagliptin -1 1481965-39-2
11 N-Nitroso-Loperamide EP Impurity C 3192-36-7
12 1-[(4-Chlorophenyl)phenylmethyl]-4-nitrosopiperazine 2005-04-1
13 N-Nitroso Vibegron Not available
14 Nitroso Verapamil Impurity B Not available
15 N-Nitroso Verapamil Impurity 2 Not available
16 N-Nitroso Verapamil Impurity 3 Not available
17 N-Nitroso Verapamil Impurity 4 Not available
18 N-Nitroso Verapamil Impurity 5 Not available
19 N-Methyl-N’-nitrosopiperazine 16339-07-4
20 Pemafibrate Nitroso Impurity-I Not available
21 N-Nitroso boc-piperazine 877177-42-9
22 N-Nitroso benzonatate Not available
23 N-Nitroso ambroxol Not available
24 Ethyl 4-(butylnitrosoamino)benzoate 101265-45-6
25 Tofacitinib Nitroso Impurity-I Not available
26 Tofacitinib Nitroso Impurity-II Not available
27 1-Cyclopentyl-4-nitrosopiperazine 61379-66-6
28 1-Cyclohexyl-4-nitrosopiperazine Not available
29 N-Nitroso piperidine 100-75-4
30 1-nitrosopiperazine 5632-47-3
31 1,4-dinitrosopiperazine 140-79-4
32 4-(Nitrosomethylamino) pyridine 16219-99-1
33 N-Nitroso pyrrolidine 930-55-2
34 4-(Diphenylmethyl)-1-nitrosopiperidine 94067-39-7
35 N-Nitroso moxifloxacin Not available
36 Moxifloxacin nitroso impurity-2 Not available
37 Moxifloxacin nitroso impurity-3 Not available
38 Moxifloxacin nitroso impurity-4 Not available
39 Moxifloxacin nitroso impurity-5 Not available
40 Moxifloxacin nitroso impurity-6 Not available
41 N-desmethyl-n-nitroso sildenafil Not available
42 1-(3-Chlorophenyl)-4-nitrosopiperazine 2219339-13-4
43 Piperazine, 1-(2,3-dichlorophenyl)-4-nitroso-
(Aripiprazole nitroso impurity-1)
2989508-28-1
44 Mebeverine nitroso impurity-1 Not available
45 Mebeverine nitroso impurity-2 Not available
46 Mebeverine nitroso impurity-3 Not available
47 N-Nitroso vortioxetine 2925447-38-5
48 4-methoxybenzyl 4-nitrosopiperazine-1-carboxylate Not available
49 Phenylmethyl 4-nitroso-1-piperazinecarboxylate 161683-14-3
50 Phenylmethyl hexahydro-4-nitroso-1H-1,4-diazepine-1-carboxylate 211748-65-1
51 N,N-bis(2-bromoethyl)nitrous amide Not available
52 N,N-bis(2-chloroethyl)nitrous amide Not available
53 1-(2-Bromophenyl)-4-nitrosopiperazine Not available
54 1-(4-Bromophenyl)-4-nitrosopiperazine 2648941-13-1
55 1-(2-Chlorophenyl)-4-nitrosopiperazine 2221987-86-4
56 1-(2-Fluorophenyl)-4-nitrosopiperazine 2731009-71-3
57 1-(4-Chlorophenyl)-4-nitrosopiperazine 873395-52-9
58 1-(3-Chlorophenyl)-4-nitrosopiperazine 2219339-13-4
59 1-(2-Methylphenyl)-4-nitrosopiperazine 2751615-89-9
60 4-(1-Nitroso-4-piperidinyl)morpholine 2089333-06-0
61 7-Nitroso-3-(trifluoromethyl)-5,6,7,8-tetrahydro[1,2,4]triazolo-[4,3-a]pyrazine (NTTP) 2892260-32-9
62 N-nitroso-1,2,3,6-tetrahydropyridine (NTHP) 55556-92-8
63 N-nitroso-varenicline 2755871-02-2
64 N-nitroso-duloxetine 2680527-91-5
65 N-nitroso-fluoxetine 150494-06-7
66 N-Nitroso-atomoxetineNot available
67 N-Nitroso atomoxetine EP Impurity-A Not available
68 N-Nitroso atomoxetine EP Impurity-B /
N-Nitroso USP Atomoxetine S-Isomer
Not available
69 N-Nitroso atomoxetine EP Impurity-C Not available
70 N-Nitroso atomoxetine EP Impurity-D /
N-Nitroso Atomoxetine USP Related Compound B
Not available
71 N-Nitroso atomoxetine EP Impurity-F Not available
72 N,N-Dinitroso atomoxetine EP Impurity-G Not available
73 Mononitroso atomoxetine EP Impurity-G Not available
74 N-Nitroso atomoxetine EP Impurity-H Not available
75 N-Desmethyl-N-Nitroso olanzapine Not available
76 N-[2-(2,6-Dimethylphenoxy)ethyl]-N-nitrosobenzenemethanamine 2348-58-5
77 2-(Diphenylmethoxy)-N-methyl-N-nitrosoethanamine 55855-43-1
78 N-Nitroso-N-desmethyl prochlorperazine 109095-35-4;
856996-47-9 [Maleate salt]
79 N-Nitroso-N-desmethyl prochlorperazine sulfoxide Not available
80 4-(methylnitrosoamino)-1-(3-pyridinyl)-1-butanone (NNK) 64091-91-4
81 N-Nitrosopropranolol 84418-35-9
82 N-Nitroso-N-Desmethyl Dapoxetine Not available
83 Nitroso Derivative of Prucalopride Impurity A Not available
84 N-Nitroso prucalopride Impurity-2 2396758-93-1
85 N-Nitroso-N-Desmethyl Mirtazapine  Not available
86 N-Nitroso N-Desethyl metoclopramide Not available
87 N-Nitrosodesmethyl chlorpromazine 55855-44-2
88 N-Nitroso Levofloxacin Related Compound-A (or)
N-Nitroso N-Desmethyl levofloxacin
1152314-62-9
89 Ibrutinib nitroso impurity-1 2256059-43-3
90 1-Nitroso-3-piperidinol 55556-85-9
91 (3S)-1-Nitroso-3-piperidinol 2380680-64-6
92 3-Bromo-1-(1-nitroso-4-piperidinyl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine 2120391-57-1
93 3-Iodo-1-(1-nitroso-4-piperidinyl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine Not available
94 N-Nitroso Bis(2-chloroethyl)amine 67856-68-2
95 1-((4-Chlorophenyl) (phenyl)methyl)-4-nitroso piperazine (or)
Cetirizine N-Nitroso Impurity
  2005-04-1
96 1-(4-Methoxyphenyl)-4-nitroso piperazine (or)
N-Nitroso Itraconazole Impurity-1

75051-59-1
97 N-Nitroso Enzalutamide Impurity-1 Not available
98 2-(1-nitrosopiperidin-4-yl)-2-phenylacetic acid 2624121-90-8
99 N-Nitroso Desmethyl Carbinoxamine Not available
100 N-Nitroso-2-hydroxymethyl atomoxetine Not available
101 N-Nitroso 4'-hydroxy atomoxetine Not available
102 1-(Methylnitrosoamino) methanol 58840-25-8
103 N-Nitroso-4-(4-Bromophenyl) piperidin-4-ol
(Bromperidol Nitroso impurity-1)
Not available
104 N-Nitroso-4-Hydroxy-4-phenylpiperidine
(Bromperidol Nitroso impurity-2)
Not available
105 N-Nitroso-4-(4-Bromophenyl)-1,2,3,6-tetrahydropyridine (Bromperidol Nitroso impurity-3) Not available
106 N-Nitroso N-Desmethyl Citalopram Not available
107 N-Nitroso Desmethyl Amitriptyline Not available N-Nitroso Desmethyl Amitriptyline
108 N-Nitroso Nortriptyline 55855-42-0
109 N-Nitroso Norcyclobenzaprine Not available
110 4-(5H-Dibenzo[a,d]cyclohepten-5-ylidene)-1-nitrosopiperidine (or) N-Nitroso-N-Desmethyl Cyproheptadine 3979-11-1
111 N-Nitroso Norcyclobenzaprine Not available
112 N-Nitroso-4-(3-Piperidinyl)benzenamine Not available
113 N-ethyl-N-Nitrosopiperazine 65504-33-8
114 1-[(4-Chlorophenyl)methyl]-4-nitrosopiperazine 3973-67-9
115 N-Nitroso solifenacin impurity-A 2659259-64-8
116 Apixaban nitroso impurity-1 Not available
117 N-Nitroso timolol impurity Not available
117 Brexpiprazole nitroso impurity 2639426-95-0
118 N-Nitroso N-Desethyl Metoclopramide Not available
119 Formoterol Nitroso Impurity Not available
120 N-Nitrosodesmethyl chlorpromazine 55855-44-2
121 N-Nitroso N-Desmethyl Doxylamine Not available
122 N-Nitroso Gefitinib Not available
123 Gefitinib nitroso impurity-1 Not available
124 Gefitinib nitroso impurity-2 Not available
125 2-Pyridinamine, N-nitroso-N-phenyl- 6631-38-5
126 2-ethylhexyl 4-[methyl(nitroso) amino]benzoate 122021-01-6
127 N-Nitroso vonoprazan 2932441-73-9
128 [5-Chloro-2-(methylnitrosoamino)phenyl]phenylmethanone;
N-Nitroso Temazepam EP Impurity A
51145-18-7
129 1-Benzhydryl-4-nitrosopiperazine 1698-25-5
130 1-(2-nitrophenyl)-4-nitrosopiperazine Not available
131 N-Nitroso elacestrant Not available
132 N-Nitroso ribociclib Not available
133 N-Nitroso N-Desmethyl DEBA Not available
134 N-Nitroso N-Desmethyl Ivabradine 3017270-16-2
135 Ivabradine nitroso impurity-I Not available
136 N-Nitroso ribociclib -2 Not available
137 Ethyl 1-nitroso-4-piperidinecarboxylate 160114-74-9;
857364-00-2 (HCl salt)
138 1-Nitroso-3-azetidine carboxylic acid 102624-97-5
139 N-Nitroso-L-azetidine carboxylic acid ethyl ester 31183-41-2
140 3-Hydroxy-N-nitrosopyrrolidine 56222-35-6
141 N-nitroso-L-pipecolic acid 30310-83-9
142 N-nitrosoproline 2571-28-0
143 N-Nitroso-D-pipecolic acid 30310-84-0
144 N-nitrososarcosine 55332-68-8
145 N-nitrososarcosine methyl ester 51938-19-3
146 N-nitrososarcosine ethyl ester 13344-50-8
147 1-nitroso-piperidine-2-carboxylic acid 4515-18-8
148 1-Nitrosonipecotic acid 65445-62-7
149 1-nitroso-piperidine-4-carboxylic acid 6238-69-3
150 N-nitrosoazetidine-2-carboxylic acid 30248-47-6
151 N-nitroso-trans-4-hydroxy-L-proline 30310-80-6
152 Trientine mononitroso impurity 2817316-41-7
153 Trientine dinitroso impurity Not available
154 N1-(2-Aminoethyl)-N1-nitroso-1,2-ethanediamine 741659-46-1;
239096-66-3 [HCl salt]
155 N-Nitroso Methotrexate EP impurity B Not available
156 N-Nitroso Methotrexate EP impurity L Not available
157 N-Nitroso Dimethyl (4-(methylamino)benzoyl) glutamate Not available
158 N-Nitroso Desethyl Dicycloverine Not available
159 N-Methyl-n-benzylnitrosamine 937-40-6
160 Clopidogrel Nitroso Impurity 2460755-43-3
161 N-Nitroso meglumine 10356-92-0
162 1,1-Dimethylethyl N-(1-nitroso-3-piperidinyl)carbamate 1973427-27-8
163 1-Nitrosopiperidin-3-amine 2819242-71-0
164 N-(2-Hydroxyethyl)-N-phenylnitrous amide 25413-76-7
165 2-[Nitroso(phenylmethyl)amino] benzoic acid 1028-91-7
166 5-Nitroso-5H-dibenzo[b,f]azepine 38652-29-8
167 Cyclopropyl(4-nitroso-1-piperazinyl)methanone 2742659-60-3
168 N1,N3-Dimethyl-N1-nitroso-1,3-propanediamine 29104-70-9
169 N1-(1-Methylethyl)-N1-nitroso-1,3-propanediamine 1689539-03-4
170 N1-(3-Aminopropyl)-N1-nitroso-1,4-butanediamine 78249-62-4
171 N1,N1,N3-Trimethyl-N3-nitroso-1,3-propanediamine 2731010-51-6
172 N1,N3-Dimethyl-N1,N3-dinitroso-1,3-propanediamine 6972-76-5
173 N-Nitroso-L-proline 7519-36-0
174 1-(Benzo[b]thiophen-4-yl)-4-nitrosopiperazine 2639426-95-0
175 1-(Benzo[b]thiophen-4-yl)-4-nitrosopiperazine 2639426-95-0
176 N-Nitroso despiramine (or)
N-Nitroso-N-Desmethyl Imipramine
57164-17-7
177 N-Nitroso-N-Desmethyl clopiramine Not available
178 3-Chloro-5-nitroso-5H-dibenzo[b,f]azepine 959007-11-5
179 3-Chloro-5-nitroso-10,11-dihydro-5H-dibenzo[b,f]azepine 78213-40-8
180 3,7-Dichloro-5-nitroso-10,11-dihydro-5H-dibenzo[b,f]azepine 41075-14-3
181 N-nitroso-quinapril 2922985-13-3
182 N-Nitroso Amoxapine Not available
183 N-Nitroso Morniflumate Not available
184 2-[Nitroso[3-(trifluoromethyl)phenyl]amino]benzoic acid 23595-00-8
185 N-Nitroso Propafenone NA
186 N-Nitroso hydralazine Not available
187 N-Nitroso epinephrine 3006789-99-4
188 allyl 2-((3-fluoro-4-(methylcarbamoyl)phenyl)(nitroso)amino)-2-methylpropanoate
N-Nitroso Enzalutamide impurity-1
Not available
189 2-((3-fluoro-4-(methylcarbamoyl)-phenyl)-(nitroso)amino)-2-methyl-propanoicacid
N-Nitroso Enzalutamide impurity-2
Not available
190 N-Nitroso dibenzylamine 5336-53-8
191 1-(1-nitrosopiperidin-4-yl)-1,3-dihydro-2H-benzo[d]imidazol-2-one
Nitroso impurity for Benperidol and Pimozide
Not available
192 N-Nitroso-bis ( 2-hydroxypropylamine) 53609-64-6
193 N-Nitroso ciprofloxacin 864443-44-7
194 N-Nitroso-N-Desmethyl tetracaine Not available
195 N-Nitroso tetracaine Not available
196 N-Nitroso Lidocaine EP Impurity E Not available
197 N-Nitroso N-Desmethyl Mirtazapine Not available
198 Glycopyrrolate Nitroso Impurity-1 Not available
199 N-Nitroso perindopril Not available
200 N-Nitroso perindopril impurity A 2912492-21-6
201 N-Nitroso perindopril impurity B Not available
202 N-Nitroso perindopril impurity E Not available
203 N-Nitroso perindopril impurity I Not available
204 1,2-Ethanediamine, N1,N2-dinitroso-N1,N2-bis(phenylmethyl)- 69239-61-8
205 N-Nitroso-N,N'-dibenzylethanediamine Not available
206 N-Nitroso N-Methyl Valacyclovir Not available
207 N-Nitroso N-Ethyl Valacyclovir Not available
208 N-Nitroso degarelix

Not available

NA
209 Prucalopride Nitroso impurity-2; N-Nitroso-4-aminopiperidine Not available
210 4-(1-Nitroso-4-piperidinyl)morpholine 2089333-06-0
211 3-(4-nitrosopiperazin-1-yl)benzo[d]isothiazole
Lurasidone and Ziprasidone nitroso impurity
Not available
212 N-Methyl-N-nitroso-1-naphthalenemethanamine
(Terbinafine nitroso impurity-1)
296760-88-8
213 N-Nitroso N-Desmethyl Terbinafine Not available
214 N-(1-Naphthalenylmethyl)-N-nitroso-1-naphthalenemethanamine
(Terbinafine nitroso impurity-2)
854390-56-0
215 N-Nitroso-N-desmethyl imatinib 2816369-80-7
216 Ethanol, 2-[2-(4-nitroso-1-piperazinyl)ethoxy] 73486-81-4
217 4-Nitroso-1-piperazineethanol 48121-20-6
218 N-(2-aminoethyl)-N-(2-hydroxyethyl) nitrous amide Not available
219 2-(4-nitrosopiperazin-1-yl)ethan-1-amine Not available
220 N-Nitroso Sertraline 3006789-98-3
221 N-Nitroso Sertraline EP impurity-A; N-Nitroso Sertraline USP Related compound A Not available
222 N-Nitroso Sertraline EP Impurity-B; N-Nitroso 2,3-Deschlorosertraline Not available
223 N-Nitroso Sertraline EP Impurity-C; N-Nitroso 3-Deschlorosertraline Not available
224 N-Nitroso Sertraline EP Impurity-D; N-Nitroso 4-Deschlorosertraline Not available
225 N-Nitroso 2,3-Isosertraline Not available
226 N-Nitroso N-Desmethyl Zolmitriptan Not available
227 N-Nitroso Viloxazine Not available
228 2-[Nitroso(phenylmethyl)amino] ethanol 77817-40-4
229 N-Nitroso-2-Morpholinemethanol Not available
230 Pemafibrate Nitroso Impurity-II Not available
231 Pemafibrate Nitroso Impurity-III Not available
232 Pemafibrate Nitroso Impurity-IV Not available
233 N-Nitroso Anagrelide Related Compound-A Not available
234 Ethyl N-(2,3-dichloro-6-nitrobenzyl)-N-nitrosoglycinate Not available
235 N-Nitroso Dorzolamide Not available
236 N-Nitroso Rasagiline 2470278-90-9
237 Rasagiline Nitroso impurity-I 2667609-96-1
238 Rasagiline Nitroso impurity-II Not available
239 Benzoic acid, 4-(methylnitrosoamino)-, 2-ethylhexyl ester 122021-01-6
240 N-Nitroso-N-(phenylmethyl)-2-pyridinamine 13980-62-6
241 N-Nitroso dasatinib impurity-1 2135905-86-9
242 1-(5-Chloro-2-pyridinyl)-4-nitrosopiperazine 1082404-28-1
243 4-chloro-2-methyl-6-(4-nitrosopiperazin-1-yl)pyrimidine Not available
244 Fezolinetant Nitroso Impurity-I Not available
245 Fezolinetant Nitroso Impurity-I Not available
246 N-Nitroso Bupropion 2763780-10-3
247 N-Nitroso Deschloro Bupropion Not available
248 N-Nitroso o-Bupropion Not available
249 N-Nitroso Bupropion Related Compound A Not available
250 N-Nitroso Bupropion Related Compound B Not available
251 N-Nitroso-4-Chlorobupropion Not available
252 N-Nitroso-5-Chlorobupropion Not available
253 N-Nitroso Aripiprazole Desethylene Impurity Not available
254 N-Nitroso Enzalutamide Impurity-D Not available
255 4-Nitroso-1-piperazinecarboxaldehyde 2455384-08-2
256 N-Nitroso-p-Chloro-Benzylamino-Pyridine (N-CBAP) Not available
257 N-Nitroso Metolazone Not available
258 N-Nitroso-Metolazone EP impurity A; meta-Metolazone Not available
259 N-Nitroso-Metolazone EP impurity B; para-Metolazone Not available
260 N-Nitroso-Metolazone EP impurity C; Desmethyl Metolazone Not available
261 N-Nitroso-Alverine Citrate EP Impurity C Not available
262 N-Nitroso N-Desethyl Alverine 871884-77-4
263 N-Nitroso-N-Ethylcyclohexanepropanamine Not available
264 N-Nitrosoethylmethyl amine 10595-95-6
265 N- Nitroso Dipropylamine 621-64-7
266 Bilastine Nitroso Impurity 1 2731008-04-9
267 Bilastine Nitroso Impurity 2 Not available
268 N-Nitroso Vildagliptin Not available
269 N-Nitroso Vildagliptin amide Not available
270 N-Nitroso silodosin Not available
271 N-Nitroso dehydrosilodosin Not available
272 N-Nitroso silodosin nitrile Not available
273 N-Nitroso O-Acetylsilodosin Not available
274 N-Nitroso silodosin n-oxide Not available
275  

N-Nitroso Racemic Stage I of Silodosin

Not available
276 N-Nitroso Nebivolol (Mixture of isomers) 1391051-68-5
277 N-Nitroso Nebivolol EP Impurity-A Not available
278 N-Nitroso Nebivolol EP Impurity-B Not available
279 N-Nitroso Nebivolol EP Impurity-D Not available
280 N-Nitroso Domperidone EP Impurity-A Not available
281 2H-Benzimidazol-2-one, 1,3-dihydro-1-(1-nitroso-4-piperidinyl)- 3031791-88-2
282 N-Nitroso-N-(4-Chloro-2-nitrophenyl)-4-piperidinamine Not available
283 N-Nitroso Phenylephrine EP Impurity-B;
N-Nitroso phenylephrone
Not available
284 N-Nitroso Phenylephrine 78658-64-7
285 N-Nitroso adrenalone Not available
286 N-Nitroso Terbutaline Not available
287

N-Nitroso Terbutaline Impurity-C;
N-Nitroso Terbutalone

Not available
288 N-Nitroso-N-Desmethy eletriptan Not available
289 N-nitroso-desmethyl-desvenlafaxine Not available
290 N-nitroso-desmethyl-venlafaxine 2680662-11-5
291 N-Desacetyl-N-Nitroso ketoconazole; N-Nitroso ketoconazole EP Impurity-D Not available
292 4-(4-nitrosopiperazin-1-yl)phenol Not available
293 N-Nitroso Tamsulosin 2892260-31-8
294 2-(4-Nitroso-1-piperazinyl) pyrimidine
(N-Nitroso Buspirone Impurity-A)
872826-80-7
295 N1,N1,N2-Trimethyl-N2-nitroso-1,2-ethanediamine
(Osemertinib Nitroso Impurity-1)
23834-30-2
296 N1,N2-Dimethyl-N1,N2-dinitroso-1,2-ethanediamine 13256-12-7
297 N-Nitroso Osimertinib Not available
298 N-Nitroso N-Desmethyl Osimertinib-1 Not available
299 N-Nitroso N-Desmethyl Osimertinib-2 Not available