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Impurity reference standards

Fluconazole impurity standards

24 characterised compounds linked to Fluconazole are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 9 pharmacopoeial impurities, 1 isotope-labelled standard and 1 degradation product.

24reference materials
9pharmacopoeial
1isotope labelled
1degradants
Fluconazole structure
Parent API

Fluconazole

CAS
86386-73-4
Formula
C13H12F2N6O
MW
306.27 g/mol
Code
ZX-003968

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial9EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Degradants1N-oxides, dimers, lactones and breakdown products

Counts are based on product names. One compound can fall into more than one type.

All Fluconazole reference materials

1–24 of 24 standards
Fosfluconazole
CAS
194798-83-9
Formula
C13H13F2N6O4P
MW
386.25 g/mol
ZX-039180
Questions

Fluconazole impurities, answered

How many Fluconazole impurity standards does Zemixal list?
The catalogue currently lists 24 compounds for Fluconazole, including 9 pharmacopoeial impurities, 1 isotope-labelled standard and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Fluconazole 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 Fluconazole 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.
Are isotope-labelled Fluconazole standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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