S.No

 Impurities

IUPAC NAME

CAS NO

 

M.F & MOl.Wt

Structure

Quetiapine Fumarate Impurities

1
EP Impurity-A
2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethyl acetate
844639-07-2
C23H27N3O3S/425.54
 1
2
EP Impurity-B
11-(Piperazin-1-yl)dibenzo [b,f][1,4]thiazepine.HCl
111974-74-4
C17H18ClN3S / 331.86
 clip_image002
3
EP Impurity-C
2-(2-(4-(Dibenzo[b,f][1,4] thiazepin-11-yl)piperazin-1-yl)ethoxy)ethyl 2-(4-(dibenzo[b,f][1,4]thiazepin-11-yl) piperazin
1798840-31-9
C40H42N6O3S2 / 718.93
 clip_image002
4
EP Impurity-D
1,4-Bis(dibenzo[b,f][1,4] thiazepin-11-yl)piperazine                              -1-yl)acetate
945668-94-0
C30H24N4S2 /  504.67
 clip_image002
5
EP Impurity-E
1,2-bis[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethane
1371638-05-9
C40H44N6O2S2 / 704.95
 clip_image002
6
EP Impurity-F
(2-((2-Aminophenyl)thio) phenyl) (4-(2-(2-hydroxy ethoxy)ethyl)piperazin-1-yl) methanone
848814-27-7
C21H27N3O3S / 401.52
 clip_image002
7
EP Impurity-G
Dibenzo-(1,4)-thiazepine-11(10H)-One
3159-07-7
C13H9NOS/ 227.28
 clip_image002
8
EP Impurity-H
2-[2-(4-Dibenzo[b,f][1,4] thiazepin-11-yl-piperazin-1-yl-1-oxide)ethoxy]ethanol
1076199-40-0
C21H25N3O3S /  399.51
 clip_image002
9
 EP Impurity-I
2-[4-(Dibenzo[b,f][1,4] thiazepin-11-yl)piperazin-1-1yl]ethanol.HCl
329218-14-6
C19H21N3OS /339.45
 clip_image002
10
EP Impurity-J
2-[2-(2-{2-[4-(Dibenzo[b,f] [1,4]thiazepin-11-yl)piperazin -1-yl]ethoxy}ethoxy)ethoxy] ethanol
1356906-17-6
C25H33N3O4 / 471.61
 clip_image002
11
EP Impurity-K
N-(2-((2-(4-(2-(2-Hydroxy ethoxy)ethyl)piperazine-1-carbonyl)phenyl) thio) phenyl)acetamide HCl
1371638-10-6
C24H33N3O4S / 459.60
 clip_image002
12
EP Impurity-L
2-(2-(4-(9-Chlorodibenzo[b,f] [1,4]thiazepin-11-yl)piperazin -1-yl)ethoxy) ethanol
1371638-11-7
C21H24ClN3O2S /  417.95
 clip_image002
13
EP Impurity-N
4-[2-[2-(4-Dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethyl]-1-[(2-hydroxyethoxyl)ethyl]-piperazine
1800291-86-4
C29H41N5O3S / 539.73
 clip_image002
14
EP Impurity-O
11-(4-(2-(2-(Trityloxy)ethoxy) ethyl)piperazin-1-yl)dibenzo [b,f][1,4]thiazepine
844639-06-1
C40H39N3O2S / 625.82
 clip_image002
15
EP Impurity-P
11-(4-Ethylpiperazin-1-yl) dibenzo[b,f][1,4]thiazepineHCl
1011758-03-4
C19H21N3S / 323.46
 clip_image002
16
EP Impurity-Q
4-(Dibenzo[b,f][1,4] thiazepin-11-yl)-1,1-bis[2-(2-hydroxy ethoxy) ethyl]piperazin-1-ium
         N/A
C25H34N3O4S / 472.62
 clip_image002
17
EP Impurity-R
(E)-4-Ethoxy-4-oxobut-2-enoic acid
5/4/2459
18
EP Impurity-S
2-[2-[4-(5-Oxidodibenzo [b,f][1,4]thiazepin-11-yl)-1-piperazinyl]ethoxy]ethanol HCl
329216-63-9
C21H25N3O3S / 399.51
 clip_image002
19
EP Impurity-T
4-(Dibenzo[b,f][1,4]thiazepin-11-yl)morpholine
5747-46-6
C17H16N2OS / 296.39
 clip_image002
20
EP Impurity-U
Dibenzo[b,f][1,4]thiazepin-11-amine
5786-26-5
C13H10N2S / 226.30
 clip_image002
21
EP Impurity-V
2-(2-(4-(Phenanthridin-6-yl)piperazin-1-yl)ethoxy) ethanol
     N/A(U/D)
C21H25N3O2 / 351.44
 clip_image002
22
EP Impurity-w
11-(2-(2-(4-(Dibenzo[b,f][1,4] thiazepin-11-yl)piperazin-1-yl)ethoxy)ethoxy) dibenzo [b,f][1,4]thiazepine
1800608-95-0
C34H32N4O2S2 / 592.77
 clip_image002
23
HEEP Impurity
1-[2-(2-Hydroxyethoxy) ethyl]piperazine
13349-82-1
C8H18N2O2 / 174.24
 clip_image002

ES-Omeprazole Impurities

24
EP Impurity-A
5-methoxy-1H-benzo[d]imidazole-2-thiol
37052-78-1
C8H8N2OS / 180.23
 clip_image002
25
EP Impurity-B
2-(((3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-5-methoxy-1H-benzo[d]imidazole
110374-16-8
C16H17N3O2S / 315.39
 clip_image002
26
EP Impurity-C
5-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl) methyl) thio)-1H-benzo [d]imidazole.
73590-85-9
C17H19N3O2S / 329.42
 clip_image002
27
EP Impurity-D
5-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl) methyl)sulfonyl)-1H-benzo [d]imidazole
88546-55-8
C17H19N3O4S / 361.42
 clip_image002
28
EP Impurity-E
4-methoxy-2-(((5-methoxy-1H-benzo[d]imidazol-2-yl)sulfinyl)methyl)-3,5-dimethylpyridine 1-oxide
176219-04-8
C17H19N3O4S / 361.42
 clip_image002
29
EP Impurity F&G Mixture
1,3-Dimethyl-8-methoxy-12-thioxopyrido[1′,2′:3,4]imidazo[1,2-a]benzimidazol-2(12H)-one and  1,3-                                                            Dimethyl-9-methoxy-12-thioxopyrido[1′,2′:3,4]imidazo[1,2-a]benzimidazol-2(12H)-one Mixture
125656-82-8 & 125656-83-9
C16H13N3O2S / 311.36
 clip_image002

+

clip_image002

30
EP Impurity-H
2-(((4-chloro-3,5-dimethyl pyridin-2-yl)methyl)sulfinyl)-5-methoxy-1H-benzo[d] imidazole
863029-89-4
C16H16ClN3O2S / 349.84
 clip_image002
31
EP Impurity-I
4-methoxy-2-(((5-methoxy-1H-benzo[d]imidazol-2-yl)sulfonyl)methyl)-3,5-dimethylpyridine 1-oxide
158812-85-2
C17H19N3O5S / 377.41
 clip_image002
32
Chloro Impurity
2-Chloromethyl-3,5-dimethyl-4-methoxypyridine HCl
86604-75-3
C9H13Cl2NO/ 222.11
 clip_image002
33
Es-Omeprazole impurity at 0.25 RRT
1-(5-methoxy-1H-benzo [d] imidazol-2-yl)-3,5-dimethyl-4-oxo-1,4-dihydropyridine-2-carboxylic acid
1227380-90-6
C16H15N3O4 / 313.31
 clip_image002

Aspirin Impurities

34
4-Hydroxy benzoic acid
99-96-7
C7H6O3 / 138.12
 clip_image002
35
4-Hydroxy Isopthalic acid
636-46-4
C8H6O5 / 182.13
 clip_image002
36
2-Hydroxy benzoic acid
69-72-7
C7H6O3 / 138.12
 clip_image002
37
2-((2-Acetoxybenzoyl)oxy) benzoic acid
530-75-6
C16H12O/ 300.26
 clip_image002
38
2-((2-Hydroxybenzoyl)oxy) benzoic acid
552-94-3
C14H10O5 / 258.23
 clip_image002
39
2-Acetoxybenzoic anhydride
1466-82-6
C18H14O7 / 342.30
 clip_image002

Dipyridamole Impurities

40
EP-Impurity-A
2,2′-[[4,6,8-Tri(piperidin-1-yl)pyrimido [5,4-d] pyrimidin-2-yl] nitrilo]diethanoL
16982-40-4
C25H40N8O2 / 484.64
 clip_image002
41
EP-Impurity-B
2,2′,2″,2”’,2””,2””’-[[8-(Piperidin-1-yl)pyrimido[5,4-d]pyrimidine-2,4,6-triyl] trinitrilo] hexaethanol
16908-47-7
C24H41N7O6 / 523.63
 clip_image002
42
EP-Impurity-C
2,2′-[[6-Chloro-4,8-di(piperidin-1-yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol
54093-92-4
C20H30ClN7O2 / 435.95
 clip_image002
43
EP-Impurity-D
2,2′-[[6-(2-Hydroxyethyl) amino-4,8-di(piperidin-1-yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol
1176886-12-6
C22H36N8O3 / 460.57
 clip_image002
44
EP-Impurity-E
2,2′,2”,2’’’-[[6,8-di(piperidin-1-yl)pyrimido[5,4-d]pyrimidine-2,4-diyl] dinitrilo]tetraethanol
      N/A
C24H40N8O4 / 504.63
 clip_image002
45
EP-Impurity-F
2,2′,2”,2’’’-[[4-[(2-hydroxy ethyl)amino]-8-(piperidin-1-yl)-pyrimido[5,4-d]pyrimidine-2,6-diyl]dinitrilo]tetraethanol
60286-30-8
C22H37N7O5 / 479.57
 clip_image002
46
EP-Impurity-G
6-Dichloro-4,8-di(piperidin-1-yl)-pyrimido[5,4-d]pyrimidine
2/8/7139
C16H20Cl2N6 / 367.28
 clip_image002

Metoprolol Impurities

47
EP-impurity-A
(2RS)-1-(Ethylamino)-3-[4-(2-methoxyethyl)phenoxy] propan-2-ol
109632-08-8
C14H23NO3 / 253.34
 clip_image002
48
EP-impurity-B
4-(2-Methoxyethyl)phenol
56718-71-9
C12H17ClO3 / 244.71
49
usp-impurity-B
(+/-)1-Chloro-2-hydroxy-3-[4-(2-methoxyethyl) phenoxy]-propane
56718-76-4
 clip_image002
50
EP-impurity-C
4-[2-Hydroxy-3-(1-methyl ethyl)aminopropoxy]benzaldehyde
29122-74-5
C13H19NO3 / 237.29
 clip_image002
51
EP-impurity-O
(±)-N,N-Bis[2-hydroxy-3-[4-(2-methoxyethyl) phenoxy] propyl](1-methylethyl) amine. hydrochloride
154784-36-8
C27H42ClNO6 / 512.08
 clip_image002

DiValoprex Sodium Impurities

52
Valeric acid
109-52-4
C5H10O2 / 102.13
 clip_image002
53
2-Methyl Valeric acid
97-61-0
C6H12O2 / 116.16
 clip_image002
54
2-Ethyl Valeric acid
20225-24-5
C7H14O2 / 130.18
 clip_image002
55
2-Butyl Valeric acid
      N/A
C9H18O2 / 158.24
 clip_image002
56
2-Isopropyl Valeric acid
62391-99-5
C8H16O2 / 144.21
 clip_image002
57
Methyl Valproate
22632-59-3
C9H18O2 / 158.24
 clip_image002

Ondansetron Impurities

58
EP Impurity-A
(3RS)-3-[(dimethylamino) methyl]-9-methyl-1,2,3,9-tetra hydro-4Hcarbazol-4-one.HCl
119812-29-2
C16H21ClN2O / 292.80
 clip_image002
59
EP Impurity-C
9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
27387-31-1
C13H13NO / 199.25
 clip_image002
60
EP Impurity-D
9-methyl-3-methylene-1,2,3,9-tetrahydro- carbazol-4-4H- one
99614-64-9
C14H13NO / 211.26
 clip_image002
61
EP Impurity-E
1H-Imidazole
288-32-4
C3H4N2 / 68.08
 clip_image002
62
EP Impurity-F
2-Methyl-1H-imidazole
693-98-1
C4H6N2 / 82.10
 clip_image002
63
EP Impurity-G
(3RS)-3-[(1H-Imidazol-1-yl)methyl]-9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
     N/A
C17H17N3O / 279.34
 clip_image002
64
EP Impurity-H
(3RS)-3-[(2-Methyl-1H-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one
9614-14-9
C18H19N3O / 293.36
 clip_image002

Aripiprazole Impurities

65
EP Impurity-A
7-Hydroxy-3,4-dihydro quinolin-2(1H)-one
22246-18-0
C9H9NO2 / 163.17
 clip_image002
66
EP Impurity-B
1-(2,3-Dichlorophenyl) piperazine hydrochloride
119532-26-2
C10H13Cl3N2 / 267.58
 clip_image002
67
EP Impurity-C
7-[4-[4-(2-Chlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone
203395-81-7
C23H28ClN3O2 / 413.94
 clip_image002
68
EP Impurity-D
7-[4-[4-(3-Chlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone
203395-82-8
C23H28ClN3O2 / 413.94
 clip_image002
69
EP Impurity-E
7-(4-(4-(2,3-dichlorophenyl) piperazin-1-yl)butoxy)-3,4-quinolin-2(1H)-one
129722-25-4
C23H25Cl2N3O2 /446.37
 clip_image002
70
EP Impurity-F
4-(2,3-Dichlorophenyl)-1-[4-(2-oxo-1,2,3,4-tetrahydro quinolin-7-yloxy)butyl] piperazine-1-oxide
573691-09-5
C23H27Cl2N3O3 /464.38
 clip_image002
71
EP Impurity-G
1,1′-(Ethane-1,1-diyl)bis(2,3-dichloro-4{4-[3,4-dihydro quinolin-2(1H)-one-7-yloxy butyl]piperazin-1-yl}benzene)
1797986-18-5 (Under deve lopment)
C48H56Cl4N6O4 / 922.81
 clip_image002
72
7-(4-Chlorobutoxy)-3,4-dihydroquinolin-2(1H)-one
     N/A
C12H14ClNO2 /239.70
 clip_image002
73
USP RC-B
7-(4-Hydroxy-butoxy)-3,4-dihydroquinolin-2(1H)-one
889443-20-3
C12H15NO3 / 221.25
 clip_image002
74
7-(4-Bromobutoxy)-3,4-dihydroquinolin-2-one
129722-34-5
C12H14BrNO2 / 284.15
 clip_image002
75
7,7′-[Butane-1,4,diylbis(oxy) ]bis[3,4-dihydroquinolin-2 (1H) -one
882880-12-8
C22H24N2O4  / 380.44
 clip_image002

Riluzole Impurities

76
5-(Trifluoromethoxy) benzo(d)Thiazol-2-amine
    N/A
C8H5F3N2OS / 234.20
 clip_image002
77
4-(Trifluoromethoxy ) benzo(d)Thiazol-2-amine
     N/A
C8H5F3N2OS / 234.20
 clip_image002
Lansoprazole
78
EP Impurity-A
2-[[[3-Methyl-1-oxido-4-(2,2 ,2-trifluoroethoxy)-2-pyridinyl] methyl]sulfinyl]-1H benz imidazole
213476-12-1
C16H14F3N3O3S / 385.36
 clip_image002
79
EP Impurity- B
2-[[[3-Methyl-4-(2,2,2-tri fluoro ethoxy)-2-pyridinyl] methyl]sulfonyl]-1H-benz imidazole
131926-99-3
C16H14F3N3O3S / 385.36
 clip_image002
80
EP Impurity- C
2-[[[3-Methyl-4-(2,2,2-tri fluoroethoxy)-2-pyridinyl] methyl]sulfanyl]-1H-benz imidazole
103577-40-8
C16H14F3N3OS / 353.36
 clip_image002
81
EP Impurity-D
1H-Benzimidazol-2-ol ; 2-Hydroxybenzimidazole
615-16-7
C7H6N2O / 134.14
 clip_image002
82
EP Impurity-E
2-Mercaptobenzimidazole
583-39-1
C7H6N2S / 150.20
 clip_image002
83
EP Impurity-F
2-[(RS)-[(4-Chloro-3-methyl pyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole
168167-42-8
C14H12ClN3OS / 305.78
 clip_image002
84
Sulphone-N-Oxide
 2-[[[3-Methyl-1-oxido-4-(2,2, 2 -trifluoroethoxy)-2-pyridinyl] methyl]sulfonyl]-1H-benz imidazole
953787-54-7
C16H14F3N3O4S /  401.36
 clip_image002
85
Sulphide-N-Oxide
2-[[[3-Methyl-1-oxido-4-(2,2 ,2-trifluoroethoxy)-2-pyridinyl] methyl]sulfanyl]-1H-benz imidazole
163119-30-0
C16H14F3N3O2S /  369.36
 clip_image002
86
S-Isomer
2-[(S)-[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl] methyl]sulfinyl]-1H-benz imidazole
138530-95-7
C17H18F3N3O2S /  385.40
 clip_image002
87
Chloro Impurity
2-Chloromethyl-3-methyl-4-(2,2,2-trifluoroethoxy)pyridine hydrochloride
127337-60-4
C9H9ClF3NO / 239.62
 clip_image002

Rabeprazole Sodium

88
EP Impurity-A
2-[[4-(3-Methoxypropoxy)-3-methyl-pyridin-2-yl]methyl sulfonyl]benzoimidazole
117976-47-3
C18H21N3O4S / 375.44
 clip_image002
89
EP Impurity-B
2-[[4-(3-Methoxypropoxy)-3-methyl-pyridin-2-yl]methyl sulfanyl]benzoimidazole
117977-21-6
C18H21N3O2S / 343.44
 clip_image002
90
EP Impurity-C
1-(1H-Benzimidazol-2-yl)-3-methyl-4-oxo-1,4-dihydro pyridine-2-carboxylate, sodium salt
1163685-30-0
C14H11N3O3 / 269.26
 clip_image002
91
EP Impurity-D
2-[[[1-Oxide-4-(3-methoxy propoxy)-3-methyl-2-pyri dinyl]  methyl]sulfinyl]-1H-benzimidazole
924663-38-7
C18H21N3O4S / 375.44
 clip_image002
92
EP Impurity-E
2-[[(4-Methoxy-3-methyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
924663-38-7
C15H15N3O2S / 301.36
 clip_image002
93
EP Impurity-F
2-Mercaptobenzimidazole
583-39-1
C7H6N2S / 150.20
 clip_image002
94
EP Impurity-G
2-[[(4-Methoxy-3-methyl-2-pyridinyl)methyl]sulfanyl]-1H-benzimidazole
102804-82-0
C15H15N3OS / 285.36
 clip_image002
95
EP Impurity-H
2-[(RS)-[(4-Chloro-3-methylpyridin-2-yl)methyl] sulphinyl]-1H-benzimidazole;
168167-42-8
C14H12ClN3OS / 305.78
 clip_image002
96
EP Impurity-I
2-[[[1-Oxide-4-(3-methoxy propoxy)-3-methyl-2-pyri dinyl]  methyl]sulfonyl]-1H-benzimidazole
924663-37-6
C18H21N3O5S / 391.44
 clip_image002
97
EP Impurity-K
2-Hydroxybenzimidazole
615-16-7
C7H6N2O / 134.14
 clip_image002
98
(S)-Isomer
Sodium (S)-2-[[4-(3-methoxy propoxy)-3-methyl-pyridin-2-yl]methylsulfinyl] benz imidazole
171440-19-0
C19H25N3O3S / 375.49
 clip_image002
99
Chloro impurity
2-Chloromethyl-3-methyl-4-(3-methoxypropoxy)pyridine hydrochloride
153259-31-5
C11H17Cl2NO2 / 266.16
 clip_image002
100
EP Impurity-H Sulfide
2-[(RS)-[(4-Chloro-3-methylpyridin-2-yl) methyl] sulphinyl]-1H-benzimidazole
103312-62-5
C14H12ClN3S / 289.78
 clip_image002

Paliperidone

101
USP Impurity-A
3-Ethyl-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido [1,2-a]pyrimidin-4-one hydrochloride
849727-64-6
C11H18N2O2 / 210.27
 clip_image002
102
USP Impurity-B
6-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole hydrochloride
84163-13-3
C12H14ClFN2O / 256.70
 clip_image002
103
USP Impurity-C
3-(2-Chloroethyl)-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido-(1,2-a)-pyrimidin-4-one
130049-82-0
C11H17ClN2O2 / 244.72
 clip_image002
104
USP Impurity-D
3-{2-[4-(6-Fluoro-1,2-benz isoxazol-3-yl) piperidin-1-yl] ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido [1,2-a]pyrimidin-4-one N-oxide
761460-08-6
C23H27FN4O4 / 442.48
 clip_image002
105
9-Keto Impurity
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-7,8-dihydro-2-methyl-4H-pyrido[1,2-a]pyrimidine-4,9(6H)-dione
1189516-65-1
C23H25FN4O3 / 424.47
 clip_image002

Pantoprazole Impurities

106
EP Impurity-A
5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl) methyl ]sulfonyl]-1H-benzimidazole
127780-16-9
C16H15F2N3O5S / 399.37
 clip_image002
107
EP Impurity-B
5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl) methyl ]thio]-1H-benzimidazole
102625-64-9
C16H15F2N3O3S / 367.37
 clip_image002
108
EP Impurity-C
5-(Difluoromethoxy)-2-mercapto-1H-benzimidazole
97963-62-7
C8H6F2N2OS / 216.21
 clip_image002
109
EP Impurity-D&F Mix
5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl) methyl ]sulfinyl]-1-methyl -1H-benz imidazole &  6-(Difluoro methoxy)-2-[[(3,4-dimethoxy-2-pyridinyl) methyl]sulfinyl]-1-methyl -1H-benzimidazole
624742-53-6 & 721924-06-7
C17H17F2N3O4S / 397.40
 clip_image002+clip_image002
110
N-oxide Impurity
5-(Difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methyl] sulfinyl} benzimidazol-1-ide N-oxide
953787-60-5
C16H15F2N3O5S / 399.37
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111
Sulphone-N-Oxide
5-(Difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methyl] sulfonyl} benzimidazol-1-ide N-oxide
953787-55-8
C16H15F2N3O6S / 415.37
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112
Chloro impurity
2-(Chloromethyl)-3,4-dimethoxy pyridinium hydrochloride
72830-09-2
C8H11Cl2NO2 / 224. 08
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Duloxetine Impurities

113
EP Impurity-A
(3R)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine HCl
910138-96-4 (HCl Salt)
C18H19NOS / 297.41
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114
EP Impurity-B
 (1S)-3-(Methylamino)-1-(thiophen-2-yl)propan-1-ol
116539-55-0
C8H13NOS / 171.26
 clip_image002
115
EP Impurity-C
4-[(1RS)-3-(Methylamino)-1-(thiophen-2-yl)propyl]naphthalen-1-ol hydrochloride
949096-01-9 (HBr Salt) (U/D)
C18H19NO2S / 313. 41
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116
EP Impurity-D
Naphthalen-1-ol
 90-15-3
C10H8O / 144.17
 clip_image002
117
EP Impurity-E
2-[(1RS)-3-(Methylamino)-1-(thiophen-2-yl)propyl]naphthalen-1-ol
1033719-36-6 (HCl salt) (U/D)
C18H19NO2S / 313.41
 clip_image002
118
EP Impurity-F
(3S)-N-Methyl-3-(naphthalen-1-yloxy)-3-(thiophen-3-yl)propan-1-amine.HCl
1104890-90-5 (HCl salt)
C18H19NOS / 297.41
 clip_image002
119
EP Impurity-G
1-Fluoronaphthalene
321-38-0
C10H7F / 146.16
 clip_image002
120
USP RC -H
S)-4-(Methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl) propyl]amino)-4-oxo buta noic acid ;                                                            (S)-Duloxetine Succinamide
199191-66-7
C22H23NO4S / 397.49
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Sitagliptin Impurities

121
EP Impurity-A
(S)-4-Oxo-4-[3-(trifluoro methyl)-5,6-dihydro [1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl) butan-2-amine phosphate; (S)-Sitagliptin Isomer
C16H15F6N5O / 407.31
 clip_image002
122
EP Impurity-B
(R)-4-Oxo-4-[3-(trifluoro methyl)-5,6-dihydro[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,5-difluoro phenyl) butan-2-amine phosphate; Sitagliptin 4-Desfluoro Impurity
1345822-87-8.(U/D)
C16H16F5N5O / 389.32
 clip_image002
123
EP Impurity-C
(R)-4-Oxo-4-[3-(trifluoro methyl)-5,6-dihydro[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4-difluoro phenyl) butan-2-amine phosphate; Sitagliptin 5-Desfluoro Impurity
1345822-86-7.(U/D)
C16H16F5N5O / 389.32
 clip_image002
124
Sitagliptin FP Impurity-E
(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoic acid
936630-57-8
C10H10F3NO2 / 233.19
 clip_image002
125
Sitagliptin Triazole.HCl
3-(Trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine hydrochloride
762240-92-6
C6H8ClF3N4 / 228.60
 clip_image002

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