tolvaptan and its Impurities
Tolvaptan is used to treat hyponatremia associated with congestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone. It is an aquaretic drug.Reference standards of Tolvaptan API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.

![N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azep PA 20 98520](https://www.pharmaffiliates.com/pimages/PA2098520.jpg)
N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
Catalogue No.:PA 20 98520
CAS :
1432725-23-9
Molecular Formula : C26H26N2O3
Molecular Weight : 414.5


(4-Amino-2-methylphenyl)(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)methanone
(4-Amino-2-methylphenyl)(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)methanone
Catalogue No.:PA 20 98530
CAS :
1432725-24-0
Molecular Formula : C18H19ClN2O2
Molecular Weight : 330.81


N-(4-(7-Chloro-4-methyl-5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
N-(4-(7-Chloro-4-methyl-5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
Catalogue No.:PA 20 98570
CAS :
NA
Molecular Formula : C27H25ClN2O3
Molecular Weight : 460.95

![(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b] PA 20 0981001](https://www.pharmaffiliates.com/pimages/PA200981001.jpg)
(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)(2-methyl-4-nitrophenyl)methanone
(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)(2-methyl-4-nitrophenyl)methanone
Catalogue No.:PA 20 0981001
CAS :
NA
Molecular Formula : C18H17ClN2O4
Molecular Weight : 360.79


7-Chloro-1-(2-methyl-4-(2-methylbenzamido)benzoyl)-2,3-dihydro-1H-benzo[b]azepin-5-yl 2-methyl-4-(2-methylbenzamido)benzoate
7-Chloro-1-(2-methyl-4-(2-methylbenzamido)benzoyl)-2,3-dihydro-1H-benzo[b]azepin-5-yl 2-methyl-4-(2-methylbenzamido)benzoate
Catalogue No.:PA 20 0981012
CAS :
1580889-36-6
Molecular Formula : C42H36ClN3O5
Molecular Weight : 698.22

![N-(4-(7-Chloro-2,3-dihydro-1H-benzo[b]azepine-1-ca PA 20 0981016](https://www.pharmaffiliates.com/pimages/PA200981016.jpg)
N-(4-(7-Chloro-2,3-dihydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
N-(4-(7-Chloro-2,3-dihydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
Catalogue No.:PA 20 0981016
CAS :
176970-21-1
Molecular Formula : C26H23ClN2O2
Molecular Weight : 430.93

![N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azep PA 20 0981018](https://www.pharmaffiliates.com/pimages/PA200981018.jpg)
N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)phenyl)-2-methylbenzamide
N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)phenyl)-2-methylbenzamide
Catalogue No.:PA 20 0981018
CAS :
150681-19-9
Molecular Formula : C25H24N2O3
Molecular Weight : 400.48


N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)phenyl)-2-methylbenzamide
N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)phenyl)-2-methylbenzamide
Catalogue No.:PA 20 0981019
CAS :
150683-27-5
Molecular Formula : C25H23ClN2O3
Molecular Weight : 434.92


N-(4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-3-methylbenzamide
N-(4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-3-methylbenzamide
Catalogue No.:PA 20 0981023
CAS :
1580889-27-5
Molecular Formula : C26H25ClN2O3
Molecular Weight : 448.95

![N-(4-(7-Chloro-5-methoxy-2,3-dihydro-1H-benzo[b]az PA 20 0981024](https://www.pharmaffiliates.com/pimages/PA200981024.jpg)
N-(4-(7-Chloro-5-methoxy-2,3-dihydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
N-(4-(7-Chloro-5-methoxy-2,3-dihydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
Catalogue No.:PA 20 0981024
CAS :
2468638-31-3
Molecular Formula : C27H25ClN2O3
Molecular Weight : 460.96


N-(4-(5-Hydroxy-7-methoxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
N-(4-(5-Hydroxy-7-methoxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
Catalogue No.:PA 20 0981027
CAS :
1859917-54-6
Molecular Formula : C27H28N2O4
Molecular Weight : 444.53


(R)-N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)phenyl)-2-methylbenzamide
(R)-N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)phenyl)-2-methylbenzamide
Catalogue No.:PA 20 0981037
CAS :
2376909-00-9
Molecular Formula : C25H23ClN2O3
Molecular Weight : 434.92


1-(4-Amino-2-methylbenzoyl)-7-chloro-2,3-dihydro-1H-benzo[b]azepin-5-yl 4-amino-2-methylbenzoate
1-(4-Amino-2-methylbenzoyl)-7-chloro-2,3-dihydro-1H-benzo[b]azepin-5-yl 4-amino-2-methylbenzoate
Catalogue No.:PA 20 0981038
CAS :
1580889-35-5
Molecular Formula : C26H24ClN3O3
Molecular Weight : 461.95


tert-Butyl (3aS,10bR)-9-chloro-6-nitroso-3,3a,4,5,6,10b-hexahydrobenzo[b]pyrrolo[2,3-d]azepine-1(2H)-carboxylate
tert-Butyl (3aS,10bR)-9-chloro-6-nitroso-3,3a,4,5,6,10b-hexahydrobenzo[b]pyrrolo[2,3-d]azepine-1(2H)-carboxylate
Catalogue No.:PA 20 0981040
CAS :
NA
Molecular Formula : C17H22ClN3O3
Molecular Weight : 351.83


N-(4-(7-Chloro-5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-4-methylbenzamide
N-(4-(7-Chloro-5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-4-methylbenzamide
Catalogue No.:PA 20 0981041
CAS :
1580889-24-2
Molecular Formula : C26H23ClN2O3
Molecular Weight : 446.93


N-(4-(7-Chloro-5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)benzamide
N-(4-(7-Chloro-5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)benzamide
Catalogue No.:PA 20 0981042
CAS :
1580889-32-2
Molecular Formula : C25H21ClN2O3
Molecular Weight : 432.9


2-Methyl-N-(3-methyl-4-(5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)phenyl)benzamide
2-Methyl-N-(3-methyl-4-(5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)phenyl)benzamide
Catalogue No.:PA 20 0981046
CAS :
137977-65-2
Molecular Formula : C26H24N2O3
Molecular Weight : 412.49


N-(4-(7-Chloro-5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-(methyl-d3)benzamide-3,4,5,6-d4
N-(4-(7-Chloro-5-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-(methyl-d3)benzamide-3,4,5,6-d4
Catalogue No.:PA STI 089929
CAS :
1296212-29-7
Molecular Formula : C26H16D7ClN2O3
Molecular Weight : 453.97


(4-Amino-2-methylphenyl)(7-chloro-4-methoxy-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)methanone
(4-Amino-2-methylphenyl)(7-chloro-4-methoxy-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)methanone
Catalogue No.:PA 20 0981054
CAS :
1859916-63-4
Molecular Formula : C19H21ClN2O2
Molecular Weight : 344.84

![(S)-N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b] PA 20 0981055](https://www.pharmaffiliates.com/pimages/PA200981055.jpg)
(S)-N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
(S)-N-(4-(5-Hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide
Catalogue No.:PA 20 0981055
CAS :
NA
Molecular Formula : C26H26N2O3
Molecular Weight : 414.51


(S)-N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)benzamide
(S)-N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)benzamide
Catalogue No.:PA 20 0981056
CAS :
NA
Molecular Formula : C25H23ClN2O3
Molecular Weight : 434.92


N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-2-methylphenyl)-2-methylbenzamide
N-(4-(7-Chloro-5-hydroxy-2,3,4,5-tetrahydro-1H-benzo[b]azepine-1-carbonyl)-2-methylphenyl)-2-methylbenzamide
Catalogue No.:PA 20 0981057
CAS :
NA
Molecular Formula : C26H25ClN2O3
Molecular Weight : 448.95