Relugolix and its Impurities
Relugolix, sold under the brand names Orgovyx and Relumina. it is used in the treatment of prostate cancer in men and uterine fibroids in women. Reference standards of Relugolix API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.


1-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)-6-(4-(3-methoxyureido)phenyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-5-yl)-N,N-dimethylmethanamine oxide
1-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)-6-(4-(3-methoxyureido)phenyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-5-yl)-N,N-dimethylmethanamine oxide
Catalogue No.:PA 18 1201007
CAS :
2814571-34-9
Molecular Formula : C29H27F2N7O6S
Molecular Weight : 639.63


3-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-1-((4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)carbamoyl)-1-methoxyurea
3-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-1-((4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)carbamoyl)-1-methoxyurea
Catalogue No.:PA 18 1201006
CAS :
2814571-35-0
Molecular Formula : C57H49F4N13O9S2
Molecular Weight : 1200.21


1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-6-(4-(hydroxyamino)phenyl)-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione
1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-6-(4-(hydroxyamino)phenyl)-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione
Catalogue No.:PA 18 1201005
CAS :
NA
Molecular Formula : C27H24F2N6O4S
Molecular Weight : 566.58


1-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-2,4-dioxo-3-(6-oxo-1,6-dihydropyridazin-3-yl)-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxyurea
1-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-2,4-dioxo-3-(6-oxo-1,6-dihydropyridazin-3-yl)-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxyurea
Catalogue No.:PA 18 1201004
CAS :
1801551-07-4
Molecular Formula : C28H25F2N7O5S
Molecular Weight : 609.61


6,6'-(Hydrazine-1,2-diylbis(4,1-phenylene))bis(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione)
6,6'-(Hydrazine-1,2-diylbis(4,1-phenylene))bis(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione)
Catalogue No.:PA 18 1201003
CAS :
NA
Molecular Formula : C54H46F4N12O6S2
Molecular Weight : 1099.15


1,3-bis(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)urea
1,3-bis(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)urea
Catalogue No.:PA 18 1201002
CAS :
NA
Molecular Formula : C55H46F4N12O7S2
Molecular Weight : 1127.16


1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-6-(4-nitrophenyl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione
1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-6-(4-nitrophenyl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione
Catalogue No.:PA 18 1201001
CAS :
1589503-96-7
Molecular Formula : C27H22F2N6O5S
Molecular Weight : 580.57


6-(4-Aminophenyl)-1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione
6-(4-Aminophenyl)-1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione
Catalogue No.:PA 18 1201000
CAS :
1589503-93-4
Molecular Formula : C27H24F2N6O3S
Molecular Weight : 550.58


6-(4-Aminophenyl)-1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione Oxalate
6-(4-Aminophenyl)-1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione Oxalate
Catalogue No.:PA 18 1201008
CAS :
2636079-41-7
Molecular Formula : C29H26F2N6O7S
Molecular Weight : 640.62


1-(4-(5-(Chloromethyl)-1-(2,6-difluorobenzyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxyurea
1-(4-(5-(Chloromethyl)-1-(2,6-difluorobenzyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxyurea
Catalogue No.:PA 18 1201009
CAS :
737790-51-1
Molecular Formula : C27H21ClF2N6O5S
Molecular Weight : 615.01


Isopropyl (2,6-difluorobenzyl)(4-((dimethylamino)methyl)-3-((6-methoxypyridazin-3-yl)carbamoyl)-5-(4-(3-methoxyureido)phenyl)thiophen-2-yl)carbamate
Isopropyl (2,6-difluorobenzyl)(4-((dimethylamino)methyl)-3-((6-methoxypyridazin-3-yl)carbamoyl)-5-(4-(3-methoxyureido)phenyl)thiophen-2-yl)carbamate
Catalogue No.:PA 18 1201010
CAS :
2814571-39-4
Molecular Formula : C32H35F2N7O6S
Molecular Weight : 683.73


1-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)urea
1-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)urea
Catalogue No.:PA 18 1201011
CAS :
2814571-30-5
Molecular Formula : C28H25F2N7O4S
Molecular Weight : 593.61


2-((2,6-Difluorobenzyl)amino)-4-((dimethylamino)methyl)-N-(6-methoxypyridazin-3-yl)-5-(4-(3-methoxyureido)phenyl)thiophene-3-carboxamide
2-((2,6-Difluorobenzyl)amino)-4-((dimethylamino)methyl)-N-(6-methoxypyridazin-3-yl)-5-(4-(3-methoxyureido)phenyl)thiophene-3-carboxamide
Catalogue No.:PA 18 1201012
CAS :
2814571-33-8
Molecular Formula : C28H29F2N7O4S
Molecular Weight : 597.64


1-(4-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)-5-((methyl(nitroso)amino)methyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxyurea
1-(4-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)-5-((methyl(nitroso)amino)methyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxyurea
Catalogue No.:PA 18 1201013
CAS :
NA
Molecular Formula : C28H24F2N8O6S
Molecular Weight : 638.61


Ethyl (4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)carbamate
Ethyl (4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)carbamate
Catalogue No.:PA 18 1201014
CAS :
NA
Molecular Formula : C30H28F2N6O5S
Molecular Weight : 622.65


4-((Dimethylamino)methyl)-2-((ethoxycarbonyl)(2-fluorobenzyl)amino)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
4-((Dimethylamino)methyl)-2-((ethoxycarbonyl)(2-fluorobenzyl)amino)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
Catalogue No.:PA 18 1201015
CAS :
NA
Molecular Formula : C24H24FN3O6S
Molecular Weight : 501.53


2-((2,6-Difluorobenzyl)amino)-4-((dimethylamino)methyl)-N-(6-methoxypyridazin-3-yl)-5-(4-nitrophenyl)thiophene-3-carboxamide
2-((2,6-Difluorobenzyl)amino)-4-((dimethylamino)methyl)-N-(6-methoxypyridazin-3-yl)-5-(4-nitrophenyl)thiophene-3-carboxamide
Catalogue No.:PA 18 1201016
CAS :
2814571-32-7
Molecular Formula : C26H24F2N6O4S
Molecular Weight : 554.57


1-(4-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)-5-((methylamino)methyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxyurea
1-(4-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)-5-((methylamino)methyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxyurea
Catalogue No.:PA 18 1201017
CAS :
737790-54-4
Molecular Formula : C28H25F2N7O5S
Molecular Weight : 609.61


1-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxy-1-nitrosourea
1-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxy-1-nitrosourea
Catalogue No.:PA 18 1201019
CAS :
NA
Molecular Formula : C29H26F2N8O6S
Molecular Weight : 652.63


2-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)ureido)-4-((dimethylamino)methyl)-5-(4-(3-methoxyureido)phenyl)thiophene-3-carboxylic Acid
2-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)ureido)-4-((dimethylamino)methyl)-5-(4-(3-methoxyureido)phenyl)thiophene-3-carboxylic Acid
Catalogue No.:PA 18 1201020
CAS :
NA
Molecular Formula : C29H29F2N7O6S
Molecular Weight : 641.65


2-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)ureido)-4-((dimethylamino)methyl)-5-(4-(3-methoxyureido)phenyl)thiophene-3-carboxylic acid
2-(1-(2,6-Difluorobenzyl)-3-(6-methoxypyridazin-3-yl)ureido)-4-((dimethylamino)methyl)-5-(4-(3-methoxyureido)phenyl)thiophene-3-carboxylic acid
Catalogue No.:PA 18 1201021
CAS :
3046102-25-1
Molecular Formula : C29H29F2N7O6S
Molecular Weight : 641.65


1-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxy-1-(methoxycarbamoyl)urea
1-(4-(1-(2,6-Difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-3-methoxy-1-(methoxycarbamoyl)urea
Catalogue No.:PA 18 1201022
CAS :
NA
Molecular Formula : C31H30F2N8O7S
Molecular Weight : 696.69


2-((2,3-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
2-((2,3-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
Catalogue No.:PA 18 1201023
CAS :
NA
Molecular Formula : C24H23F2N3O6S
Molecular Weight : 519.52


2-((2,4-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
2-((2,4-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
Catalogue No.:PA 18 1201024
CAS :
NA
Molecular Formula : C24H23F2N3O6S
Molecular Weight : 519.52


2-((2,5-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
2-((2,5-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
Catalogue No.:PA 18 1201025
CAS :
NA
Molecular Formula : C24H23F2N3O6S
Molecular Weight : 519.52


2-((3,4-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
2-((3,4-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
Catalogue No.:PA 18 1201026
CAS :
NA
Molecular Formula : C24H23F2N3O6S
Molecular Weight : 519.52


2-((3,5-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
2-((3,5-Difluorobenzyl)(ethoxycarbonyl)amino)-4-((dimethylamino)methyl)-5-(4-nitrophenyl)thiophene-3-carboxylic Acid
Catalogue No.:PA 18 1201027
CAS :
NA
Molecular Formula : C24H23F2N3O6S
Molecular Weight : 519.52