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 

 
																				 
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