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Impurity reference standards

Obeticholic Acid impurity standards

For Obeticholic Acid, the Zemixal catalogue holds 23 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 6 metabolites or hydroxylated analogues and 1 degradation product.

23reference materials
6metabolites
1degradants
Obeticholic Acid WS structure
Parent API

Obeticholic Acid WS

CAS
459789-99-2
Formula
C26H44O4
MW
420.6 g/mol
Code
ZX-006692

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.

By impurity type

Metabolites6Hydroxy, 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 Obeticholic Acid reference materials

1–23 of 23 standards
Methyl
CAS
863239-58-1
Formula
C31H56O4Si2
MW
548.9 g/mol
ZX-039492
Questions

Obeticholic Acid impurities, answered

What Obeticholic Acid reference materials are available?
The catalogue currently lists 23 compounds for Obeticholic Acid, including 6 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 Obeticholic 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 Obeticholic 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.
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