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Impurity reference standards

Ursodeoxycholic Acid impurity standards

Zemixal lists 17 reference materials related to Ursodeoxycholic Acid, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 3 pharmacopoeial impurities, 1 isotope-labelled standard and 5 metabolites or hydroxylated analogues.

17reference materials
3pharmacopoeial
1isotope labelled
5metabolites

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial3EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites5Hydroxy, desmethyl and conjugated forms

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

All Ursodeoxycholic Acid reference materials

1–17 of 17 standards
Questions

Ursodeoxycholic Acid impurities, answered

How many Ursodeoxycholic Acid impurity standards does Zemixal list?
The catalogue currently lists 17 compounds for Ursodeoxycholic Acid, including 3 pharmacopoeial impurities, 1 isotope-labelled standard and 5 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 Ursodeoxycholic Acid 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 Acid 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 Ursodeoxycholic Acid 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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