itraconazole and its Impurities
Itraconazole is an antifungal medication. Itraconazole tablets and capsules are used to treat fungal infections of the toenails. Reference standards of Itraconazole API,and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.


Itraconazole - Impurity C
4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 21030
CAS :
74855-91-7
Molecular Formula : C34H36Cl2N8O4
Molecular Weight : 691.61


Itraconazole - Impurity D
4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-ylphenyl]-2-(1-methylethyl)-2,4-dihydro-3H-1,2,4-triazol3-one
Catalogue No.:PA 09 21040
CAS :
89848-49-7
Molecular Formula : C34H36Cl2N8O4
Molecular Weight : 691.61


Itraconazole - Impurity F
2-Butyl-4-[4-[4-[4-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4-dihydro-3H1,2,4-triazol-3-one
Catalogue No.:PA 09 21060
CAS :
89848-51-1
Molecular Formula : C35H38Cl2N8O4
Molecular Weight : 705.63


Itraconazole - Impurity G (BP)
4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[[cis-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl]-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 21070
CAS :
NA
Molecular Formula : C44H41Cl4N11O6
Molecular Weight : 961.68


2-(2-Butyl-d3)-4-{4-[4-(4-methyloxy-phenyl)-piperazin-1-yl]-phenyl}-2,4-dihydro-[1,2,4]-triazol-3-one
2-(2-Butyl-d3)-4-{4-[4-(4-methyloxy-phenyl)-piperazin-1-yl]-phenyl}-2,4-dihydro-[1,2,4]-triazol-3-one
Catalogue No.:PA STI 016580
CAS :
2714408-55-4
Molecular Formula : C23H26D3N5O2
Molecular Weight : 410.53


2-(sec-Butyl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
2-(sec-Butyl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 21520
CAS :
106461-41-0
Molecular Formula : C22H27N5O2
Molecular Weight : 393.49


cis-[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-yl-methyl)-1,3-dioxolan-4-yl]methyl Methanesulfonate
cis-[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-yl-methyl)-1,3-dioxolan-4-yl]methyl Methanesulfonate
Catalogue No.:PA 09 21540
CAS :
67914-86-7
Molecular Formula : C14H15Cl2N3O5S
Molecular Weight : 408.25


N-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-N-(2-(N-(4-(1-(sec-butyl)-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl)phenyl)formamido)ethyl)formamide
N-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-N-(2-(N-(4-(1-(sec-butyl)-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl)phenyl)formamido)ethyl)formamide
Catalogue No.:PA 09 21580
CAS :
NA
Molecular Formula : C35H36Cl2N8O6
Molecular Weight : 735.62


N-(4-(4-(4-(((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)hydrazinecarboxamide
N-(4-(4-(4-(((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)hydrazinecarboxamide
Catalogue No.:PA 09 21560
CAS :
89848-13-5
Molecular Formula : C30H32Cl2N8O4
Molecular Weight : 639.53


(4-(4-(4-(((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)carbamic Acid Phenyl Ester
(4-(4-(4-(((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)carbamic Acid Phenyl Ester
Catalogue No.:PA 09 21570
CAS :
89848-11-3
Molecular Formula : C36H34Cl2N6O5
Molecular Weight : 701.6


1,3-Dioxolane-4-methanol, 2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-, 4-methanesulfonate, (2R,4S)-rel-
1,3-Dioxolane-4-methanol, 2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-, 4-methanesulfonate, (2R,4S)-rel-
Catalogue No.:PA 09 0211003
CAS :
854372-78-4
Molecular Formula : C14H15Cl2N3O5S
Molecular Weight : 408.25


2-(Sec-Butyl)-4-(4-((2-((4-(((2R,4R)-2-((R)-(2,4-dichlorophenyl)(1H-1,2,4-triazol-1-yl)methyl)-1,3-dioxolan-4-yl)methoxy)phenyl)amino)ethyl)amino)phenyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
2-(Sec-Butyl)-4-(4-((2-((4-(((2R,4R)-2-((R)-(2,4-dichlorophenyl)(1H-1,2,4-triazol-1-yl)methyl)-1,3-dioxolan-4-yl)methoxy)phenyl)amino)ethyl)amino)phenyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 0211009
CAS :
NA
Molecular Formula : C33H36Cl2N8O4
Molecular Weight : 679.6


4-(4-(4-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-(sec-butyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
4-(4-(4-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-(sec-butyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 0211014
CAS :
2049588-24-9
Molecular Formula : C35H38Cl2N8O4
Molecular Weight : 705.64


4-(4-(4-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-propyl-2,4-dihydro-3H-1,2,4-triazol-3-one
4-(4-(4-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-propyl-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 0211013
CAS :
1893435-06-7
Molecular Formula : C34H36Cl2N8O4
Molecular Weight : 691.61


4-(4-(3-(4-(((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-2,3-dihydro-1H-imidazol-1-yl)phenyl)-2-(sec-butyl)-2,4-dihydro-3H-1,2,4-triazol-3-one and Enatiomer
4-(4-(3-(4-(((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-2,3-dihydro-1H-imidazol-1-yl)phenyl)-2-(sec-butyl)-2,4-dihydro-3H-1,2,4-triazol-3-one and Enatiomer
Catalogue No.:PA 09 0211019
CAS :
NA
Molecular Formula : C34H34Cl2N8O4
Molecular Weight : 689.6


4-(4-(4-(4-(((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-(prop-1-en-2-yl)-2,4-dihydro-3H-1,2,4-triazol-3-one
4-(4-(4-(4-(((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-(prop-1-en-2-yl)-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 0211017
CAS :
NA
Molecular Formula : C34H34Cl2N8O4
Molecular Weight : 689.6


rel-((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methanol
rel-((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methanol
Catalogue No.:PA 09 0211016
CAS :
67914-85-6
Molecular Formula : C13H13Cl2N3O3
Molecular Weight : 330.17


((2S,4R)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methanol
((2S,4R)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methanol
Catalogue No.:PA 09 0211015
CAS :
172587-60-9
Molecular Formula : C13H13Cl2N3O3
Molecular Weight : 330.17


4-(4-(3-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-2,3-dihydro-1H-imidazol-1-yl)phenyl)-2-(sec-butyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
4-(4-(3-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-2,3-dihydro-1H-imidazol-1-yl)phenyl)-2-(sec-butyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 0211020
CAS :
NA
Molecular Formula : C34H34Cl2N8O4
Molecular Weight : 689.6


4-(4-(4-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-(prop-1-en-2-yl)-2,4-dihydro-3H-1,2,4-triazol-3-one
4-(4-(4-(4-((2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-2-(prop-1-en-2-yl)-2,4-dihydro-3H-1,2,4-triazol-3-one
Catalogue No.:PA 09 0211026
CAS :
NA
Molecular Formula : C34H34Cl2N8O4
Molecular Weight : 689.6


1-(4-(((2R,4S)-2-((1H-1,2,4-triazol-1-yl)Methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-4-nitrosopiperazine;
1-(4-(((2R,4S)-2-((1H-1,2,4-triazol-1-yl)Methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-4-nitrosopiperazine;
Catalogue No.:PA 09 0211028
CAS :
NA
Molecular Formula : C23H24Cl2N6O4
Molecular Weight : 519.38