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Impurity reference standards

Ursodeoxycholic impurity standards

Zemixal lists 6 reference materials related to Ursodeoxycholic, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 pharmacopoeial impurity and 1 metabolite or hydroxylated analogue.

6reference materials
1pharmacopoeial
1metabolites

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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Ursodeoxycholic reference materials

Questions

Ursodeoxycholic impurities, answered

How many Ursodeoxycholic impurity standards does Zemixal list?
The catalogue currently lists 6 compounds for Ursodeoxycholic, including 1 pharmacopoeial impurity and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Ursodeoxycholic 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 Ursodeoxycholic 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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