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
|
|
2
|
EP Impurity-B
|
11-(Piperazin-1-yl)dibenzo [b,f][1,4]thiazepine.HCl
|
111974-74-4
|
|
C17H18ClN3S / 331.86
|
|
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
|
|
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
|
|
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
|
|
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
|
|
7
|
EP Impurity-G
|
Dibenzo-(1,4)-thiazepine-11(10H)-One
|
3159-07-7
|
|
C13H9NOS/ 227.28
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
15
|
EP Impurity-P
|
11-(4-Ethylpiperazin-1-yl) dibenzo[b,f][1,4]thiazepineHCl
|
1011758-03-4
|
|
C19H21N3S / 323.46
|
|
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
|
|
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
|
|
19
|
EP Impurity-T
|
4-(Dibenzo[b,f][1,4]thiazepin-11-yl)morpholine
|
5747-46-6
|
|
C17H16N2OS / 296.39
|
|
20
|
EP Impurity-U
|
Dibenzo[b,f][1,4]thiazepin-11-amine
|
5786-26-5
|
|
C13H10N2S / 226.30
|
|
21
|
EP Impurity-V
|
2-(2-(4-(Phenanthridin-6-yl)piperazin-1-yl)ethoxy) ethanol
|
N/A(U/D)
|
|
C21H25N3O2 / 351.44
|
|
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
|
|
23
|
HEEP Impurity
|
1-[2-(2-Hydroxyethoxy) ethyl]piperazine
|
13349-82-1
|
|
C8H18N2O2 / 174.24
|
|
ES-Omeprazole Impurities
|
24
|
EP Impurity-A
|
5-methoxy-1H-benzo[d]imidazole-2-thiol
|
37052-78-1
|
|
C8H8N2OS / 180.23
|
|
25
|
EP Impurity-B
|
2-(((3,5-dimethylpyridin-2-yl)methyl)sulfinyl)-5-methoxy-1H-benzo[d]imidazole
|
110374-16-8
|
|
C16H17N3O2S / 315.39
|
|
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
|
|
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
|
|
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
|
|
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
|
+
|
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
|
|
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
|
|
32
|
Chloro Impurity
|
2-Chloromethyl-3,5-dimethyl-4-methoxypyridine HCl
|
86604-75-3
|
|
C9H13Cl2NO/ 222.11
|
|
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
|
|
Aspirin Impurities
|
34
|
|
4-Hydroxy benzoic acid
|
99-96-7
|
|
C7H6O3 / 138.12
|
|
35
|
|
4-Hydroxy Isopthalic acid
|
636-46-4
|
|
C8H6O5 / 182.13
|
|
36
|
|
2-Hydroxy benzoic acid
|
69-72-7
|
|
C7H6O3 / 138.12
|
|
37
|
|
2-((2-Acetoxybenzoyl)oxy) benzoic acid
|
530-75-6
|
|
C16H12O6 / 300.26
|
|
38
|
|
2-((2-Hydroxybenzoyl)oxy) benzoic acid
|
552-94-3
|
|
C14H10O5 / 258.23
|
|
39
|
|
2-Acetoxybenzoic anhydride
|
1466-82-6
|
|
C18H14O7 / 342.30
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
46
|
EP-Impurity-G
|
6-Dichloro-4,8-di(piperidin-1-yl)-pyrimido[5,4-d]pyrimidine
|
2/8/7139
|
|
C16H20Cl2N6 / 367.28
|
|
Metoprolol Impurities
|
47
|
EP-impurity-A
|
(2RS)-1-(Ethylamino)-3-[4-(2-methoxyethyl)phenoxy] propan-2-ol
|
109632-08-8
|
|
C14H23NO3 / 253.34
|
|
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
|
|
|
|
50
|
EP-impurity-C
|
4-[2-Hydroxy-3-(1-methyl ethyl)aminopropoxy]benzaldehyde
|
29122-74-5
|
|
C13H19NO3 / 237.29
|
|
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
|
|
DiValoprex Sodium Impurities
|
52
|
|
Valeric acid
|
109-52-4
|
|
C5H10O2 / 102.13
|
|
53
|
|
2-Methyl Valeric acid
|
97-61-0
|
|
C6H12O2 / 116.16
|
|
54
|
|
2-Ethyl Valeric acid
|
20225-24-5
|
|
C7H14O2 / 130.18
|
|
55
|
|
2-Butyl Valeric acid
|
N/A
|
|
C9H18O2 / 158.24
|
|
56
|
|
2-Isopropyl Valeric acid
|
62391-99-5
|
|
C8H16O2 / 144.21
|
|
57
|
|
Methyl Valproate
|
22632-59-3
|
|
C9H18O2 / 158.24
|
|
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
|
|
59
|
EP Impurity-C
|
9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
|
27387-31-1
|
|
C13H13NO / 199.25
|
|
60
|
EP Impurity-D
|
9-methyl-3-methylene-1,2,3,9-tetrahydro- carbazol-4-4H- one
|
99614-64-9
|
|
C14H13NO / 211.26
|
|
61
|
EP Impurity-E
|
1H-Imidazole
|
288-32-4
|
|
C3H4N2 / 68.08
|
|
62
|
EP Impurity-F
|
2-Methyl-1H-imidazole
|
693-98-1
|
|
C4H6N2 / 82.10
|
|
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
|
|
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
|
|
Aripiprazole Impurities
|
65
|
EP Impurity-A
|
7-Hydroxy-3,4-dihydro quinolin-2(1H)-one
|
22246-18-0
|
|
C9H9NO2 / 163.17
|
|
66
|
EP Impurity-B
|
1-(2,3-Dichlorophenyl) piperazine hydrochloride
|
119532-26-2
|
|
C10H13Cl3N2 / 267.58
|
|
67
|
EP Impurity-C
|
7-[4-[4-(2-Chlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone
|
203395-81-7
|
|
C23H28ClN3O2 / 413.94
|
|
68
|
EP Impurity-D
|
7-[4-[4-(3-Chlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone
|
203395-82-8
|
|
C23H28ClN3O2 / 413.94
|
|
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
|
|
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
|
|
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
|
|
72
|
|
7-(4-Chlorobutoxy)-3,4-dihydroquinolin-2(1H)-one
|
N/A
|
|
C12H14ClNO2 /239.70
|
|
73
|
USP RC-B
|
7-(4-Hydroxy-butoxy)-3,4-dihydroquinolin-2(1H)-one
|
889443-20-3
|
|
C12H15NO3 / 221.25
|
|
74
|
|
7-(4-Bromobutoxy)-3,4-dihydroquinolin-2-one
|
129722-34-5
|
|
C12H14BrNO2 / 284.15
|
|
75
|
|
7,7′-[Butane-1,4,diylbis(oxy) ]bis[3,4-dihydroquinolin-2 (1H) -one
|
882880-12-8
|
|
C22H24N2O4 / 380.44
|
|
Riluzole Impurities
|
76
|
|
5-(Trifluoromethoxy) benzo(d)Thiazol-2-amine
|
N/A
|
|
C8H5F3N2OS / 234.20
|
|
77
|
|
4-(Trifluoromethoxy ) benzo(d)Thiazol-2-amine
|
N/A
|
|
C8H5F3N2OS / 234.20
|
|
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
|
|
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
|
|
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
|
|
81
|
EP Impurity-D
|
1H-Benzimidazol-2-ol ; 2-Hydroxybenzimidazole
|
615-16-7
|
|
C7H6N2O / 134.14
|
|
82
|
EP Impurity-E
|
2-Mercaptobenzimidazole
|
583-39-1
|
|
C7H6N2S / 150.20
|
|
83
|
EP Impurity-F
|
2-[(RS)-[(4-Chloro-3-methyl pyridin-2-yl)methyl]sulfinyl]-1H-benzimidazole
|
168167-42-8
|
|
C14H12ClN3OS / 305.78
|
|
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
|
|
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
|
|
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
|
|
87
|
Chloro Impurity
|
2-Chloromethyl-3-methyl-4-(2,2,2-trifluoroethoxy)pyridine hydrochloride
|
127337-60-4
|
|
C9H9ClF3NO / 239.62
|
|
Rabeprazole Sodium
|
88
|
EP Impurity-A
|
2-[[4-(3-Methoxypropoxy)-3-methyl-pyridin-2-yl]methyl sulfonyl]benzoimidazole
|
117976-47-3
|
|
C18H21N3O4S / 375.44
|
|
89
|
EP Impurity-B
|
2-[[4-(3-Methoxypropoxy)-3-methyl-pyridin-2-yl]methyl sulfanyl]benzoimidazole
|
117977-21-6
|
|
C18H21N3O2S / 343.44
|
|
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
|
|
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
|
|
92
|
EP Impurity-E
|
2-[[(4-Methoxy-3-methyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole
|
924663-38-7
|
|
C15H15N3O2S / 301.36
|
|
93
|
EP Impurity-F
|
2-Mercaptobenzimidazole
|
583-39-1
|
|
C7H6N2S / 150.20
|
|
94
|
EP Impurity-G
|
2-[[(4-Methoxy-3-methyl-2-pyridinyl)methyl]sulfanyl]-1H-benzimidazole
|
102804-82-0
|
|
C15H15N3OS / 285.36
|
|
95
|
EP Impurity-H
|
2-[(RS)-[(4-Chloro-3-methylpyridin-2-yl)methyl] sulphinyl]-1H-benzimidazole;
|
168167-42-8
|
|
C14H12ClN3OS / 305.78
|
|
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
|
|
97
|
EP Impurity-K
|
2-Hydroxybenzimidazole
|
615-16-7
|
|
C7H6N2O / 134.14
|
|
98
|
(S)-Isomer
|
Sodium (S)-2-[[4-(3-methoxy propoxy)-3-methyl-pyridin-2-yl]methylsulfinyl] benz imidazole
|
171440-19-0
|
|
C19H25N3O3S / 375.49
|
|
99
|
Chloro impurity
|
2-Chloromethyl-3-methyl-4-(3-methoxypropoxy)pyridine hydrochloride
|
153259-31-5
|
|
C11H17Cl2NO2 / 266.16
|
|
100
|
EP Impurity-H Sulfide
|
2-[(RS)-[(4-Chloro-3-methylpyridin-2-yl) methyl] sulphinyl]-1H-benzimidazole
|
103312-62-5
|
|
C14H12ClN3S / 289.78
|
|
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
|
|
102
|
USP Impurity-B
|
6-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole hydrochloride
|
84163-13-3
|
|
C12H14ClFN2O / 256.70
|
|
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
|
|
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
|
|
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
|
|
Pantoprazole Impurities
|
106
|
EP Impurity-A
|
5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl) methyl ]sulfonyl]-1H-benzimidazole
|
127780-16-9
|
|
C16H15F2N3O5S / 399.37
|
|
107
|
EP Impurity-B
|
5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl) methyl ]thio]-1H-benzimidazole
|
102625-64-9
|
|
C16H15F2N3O3S / 367.37
|
|
108
|
EP Impurity-C
|
5-(Difluoromethoxy)-2-mercapto-1H-benzimidazole
|
97963-62-7
|
|
C8H6F2N2OS / 216.21
|
|
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
|
+ |
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
|
|
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
|
|
112
|
Chloro impurity
|
2-(Chloromethyl)-3,4-dimethoxy pyridinium hydrochloride
|
72830-09-2
|
|
C8H11Cl2NO2 / 224. 08
|
|
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
|
|
114
|
EP Impurity-B
|
(1S)-3-(Methylamino)-1-(thiophen-2-yl)propan-1-ol
|
116539-55-0
|
|
C8H13NOS / 171.26
|
|
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
|
|
116
|
EP Impurity-D
|
Naphthalen-1-ol
|
90-15-3
|
|
C10H8O / 144.17
|
|
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
|
|
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
|
|
119
|
EP Impurity-G
|
1-Fluoronaphthalene
|
321-38-0
|
|
C10H7F / 146.16
|
|
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
|
|
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
|
|
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
|
|
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
|
|
124
|
Sitagliptin FP Impurity-E
|
(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoic acid
|
936630-57-8
|
|
C10H10F3NO2 / 233.19
|
|
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
|
|