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Impurity reference standards

Ketoconazole impurity standards

Zemixal lists 22 reference materials related to Ketoconazole, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 4 pharmacopoeial impurities, 3 metabolites or hydroxylated analogues and 1 degradation product.

22reference materials
4pharmacopoeial
3metabolites
1degradants
Ketoconazole structure
Parent API

Ketoconazole

CAS
65277-42-1
Formula
C26H28Cl2N4O4
MW
531.4 g/mol
Code
ZX-003971

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial4EP, USP, BP or JP named impurities
Metabolites3Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Ketoconazole reference materials

1–22 of 22 standards
Questions

Ketoconazole impurities, answered

How many Ketoconazole impurity standards does Zemixal list?
The catalogue currently lists 22 compounds for Ketoconazole, including 4 pharmacopoeial impurities, 3 metabolites or hydroxylated analogues 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 Ketoconazole 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 Ketoconazole 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.
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