((2S,4R)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methanol
- CAS
- 172587-60-9
- Formula
- C13H13Cl2N3O3
- MW
- 330.16 g/mol
ZX-030050
Impurity reference standards
Itraconazole impurity standards
For Itraconazole, the Zemixal catalogue holds 25 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 6 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues.
25reference materials
6pharmacopoeial
1nitrosamines
1isotope labelled
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial6EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Itraconazole reference materials
1–25 of 25 standards
1-(4-Amino Phenyl) 4-(4-Methoxy Phenyl) Piperazine
- CAS
- 74852-62-3
- Formula
- C17H21N3O
- MW
- 283.37 g/mol
ZX-032905
1,3-Dioxolane-4-methanol, 2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-, 4-methanesulfonate, (2R,4S)-rel
- CAS
- 854372-78-4
- Formula
- C14H15Cl2N3O5S
- MW
- 408.3 g/mol
ZX-030047
cis-[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-yl-methyl)-1,3-dioxolan-4-yl]methyl Methanesulfonate
- CAS
- 67914-86-7
- Formula
- C14H15Cl2N3O5S
- MW
- 408.3 g/mol
ZX-025197
cis-[2-Bromomethyl-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl]methyl Benzoate
- CAS
- 61397-56-6
- Formula
- C18H15BrCl2O4
- MW
- 446.1 g/mol
ZX-039294
Itraconazole 3-oxo-butyl-4-methoxy phenyl intermediate
- CAS
- 250255-72-2
- Formula
- C23H27N5O3
- MW
- 421.5 g/mol
ZX-044250
Itraconazole Desethylene-seco-piperazine Di-N-formyl Impurity
- CAS
- 1199350-02-1
- Formula
- C35H36Cl2N8O6
- MW
- 735.6 g/mol
ZX-030048
Itraconazole Hydroxy Isobutyltriazolone Impurity
- CAS
- 106461-41-0
- Formula
- C22H27N5O2
- MW
- 393.5 g/mol
ZX-025196
Rel-((2R,4S)-2-((1H-1,2,4-Triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methanol
- CAS
- 67914-85-6
- Formula
- C13H13Cl2N3O3
- MW
- 330.16 g/mol
ZX-030049
Questions
Itraconazole impurities, answered
What Itraconazole reference materials are available?
The catalogue currently lists 25 compounds for Itraconazole, including 6 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Itraconazole impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Itraconazole impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
Do you supply Itraconazole nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Itraconazole. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Itraconazole standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.