Apalutamide and its Impurities
Apalutamide, sold under the brand name Erleada among others, is a nonsteroidal antiandrogen medication which is used in the treatment of prostate cancer. It is specifically indicated for use in conjunction with castration in the treatment of non-metastatic castration-resistant prostate cancer Reference standards of Apalutamide API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.


4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzamide
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzamide
Catalogue No.:PA 01 2921000
CAS :
1332391-11-3
Molecular Formula : C20H13F4N5O2S
Molecular Weight : 463.41


4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-6,8-dioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-methylbenzamide
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-6,8-dioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-methylbenzamide
Catalogue No.:PA 01 2921001
CAS :
1332391-92-0
Molecular Formula : C21H15F4N5O3
Molecular Weight : 461.38


5-(5-(3-Fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
5-(5-(3-Fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
Catalogue No.:PA 01 2921002
CAS :
NA
Molecular Formula : C21H17F4N5O3S
Molecular Weight : 495.45


4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-6,8-dithioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-methylbenzamide
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-6,8-dithioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-methylbenzamide
Catalogue No.:PA 01 2921003
CAS :
2649802-40-2
Molecular Formula : C21H15F4N5OS2
Molecular Weight : 493.5


4-((1-((6-Cyano-5-(trifluoromethyl)pyridin-3-yl)carbamoyl)cyclobutyl)amino)-2-fluoro-N-methylbenzamide
4-((1-((6-Cyano-5-(trifluoromethyl)pyridin-3-yl)carbamoyl)cyclobutyl)amino)-2-fluoro-N-methylbenzamide
Catalogue No.:PA 01 2921005
CAS :
1950587-20-8
Molecular Formula : C20H17F4N5O2
Molecular Weight : 435.38


4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3,4]octan-5-yl)-2-fluorobenzoic acid
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3,4]octan-5-yl)-2-fluorobenzoic acid
Catalogue No.:PA 01 2921008
CAS :
1332391-04-4
Molecular Formula : C20H12F4N4O3S
Molecular Weight : 464.39


4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-(methyl-13C-d3)benzamide
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-(methyl-13C-d3)benzamide
Catalogue No.:PA STI 088918
CAS :
NA
Molecular Formula : C2013CH12D3F4N5O2S
Molecular Weight : 481.45


4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-N-methylbenzamide
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-N-methylbenzamide
Catalogue No.:PA 01 2921009
CAS :
1332389-57-7
Molecular Formula : C21H16F3N5O2S
Molecular Weight : 459.45


O-Phenyl (4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzoyl)(methyl)carbamothioate
O-Phenyl (4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzoyl)(methyl)carbamothioate
Catalogue No.:PA 01 2921017
CAS :
NA
Molecular Formula : C28H19F4N5O3S2
Molecular Weight : 613.61


4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-N-(1-((6-cyano-5-(trifluoromethyl)pyridin-3-yl)carbamoyl)cyclobutyl)-2-fluoro-N-(3-fluoro-4-(methylcarbamoyl)phenyl)benzamide
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-N-(1-((6-cyano-5-(trifluoromethyl)pyridin-3-yl)carbamoyl)cyclobutyl)-2-fluoro-N-(3-fluoro-4-(methylcarbamoyl)phenyl)benzamide
Catalogue No.:PA 01 2921016
CAS :
NA
Molecular Formula : C40H27F8N9O4S
Molecular Weight : 881.76


1-((3-fluoro-4-(methylcarbamoyl)phenyl)amino)Cyclobutane-1-Carboxylic Acid, Potassium Salt (1:1)
1-((3-fluoro-4-(methylcarbamoyl)phenyl)amino)cyclobutane-1-carboxylic acid, potassium salt (1:1)
Catalogue No.:PA 01 2921018
CAS :
2408380-71-0
Molecular Formula : C13H14FKN2O3
Molecular Weight : 304.36


Sodium 4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzoate
Sodium 4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzoate
Catalogue No.:PA 01 2921019
CAS :
NA
Molecular Formula : C20H11F4N4NaO3S
Molecular Weight : 486.38


Methyl 4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzoate
Methyl 4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzoate
Catalogue No.:PA 01 2921020
CAS :
1950587-19-5
Molecular Formula : C21H14F4N4O3S
Molecular Weight : 478.42


Ethyl 4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzoate
Ethyl 4-(7-(6-cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluorobenzoate
Catalogue No.:PA 01 2921021
CAS :
1332388-83-6
Molecular Formula : C22H16F4N4O3S
Molecular Weight : 492.45


4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-(3-fluoro-4-(methylcarbamoyl)phenyl)-N-methylbenzamide
4-(7-(6-Cyano-5-(trifluoromethyl)pyridin-3-yl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-5-yl)-2-fluoro-N-(3-fluoro-4-(methylcarbamoyl)phenyl)-N-methylbenzamide
Catalogue No.:PA 01 2921024
CAS :
2894796-76-8
Molecular Formula : C29H21F5N6O3S
Molecular Weight : 628.58


4-(N-(1-((6-Cyano-5-(trifluoromethyl)pyridin-3-yl)carbamoyl)cyclobutyl)formamido)-2-fluoro-N-methylbenzamide
4-(N-(1-((6-Cyano-5-(trifluoromethyl)pyridin-3-yl)carbamoyl)cyclobutyl)formamido)-2-fluoro-N-methylbenzamide
Catalogue No.:PA 01 2921028
CAS :
NA
Molecular Formula : C21H17F4N5O3
Molecular Weight : 463.39