Ursodiol (ursodeoxycholic acid)

Ursodiol: bile acid.

Ursodiol testing at Vanguard Laboratory: identity, purity and quantity $250 per sample, with results in 3 to 5 business days.

Structure

Ursodiol: 2D structure drawn from the PubChem record (CID 31401).

Compound data

CAS number

128-13-2

Formula

C₂₄H₄₀O₄

Molecular weight

392.57 g/mol

Type

Bile acid

Structure and names

Identity: Ursodiol

IUPAC name: (4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid

How Vanguard tests Ursodiol

Method for the $250 identity, purity and quantity test: Chromatographic assay, with detection selected for the compound, against a reference standard, with results in 3 to 5 business days.

The USP monograph covers identity by infrared spectroscopy, melting range and specific rotation, assay by HPLC, related compounds by TLC, loss on drying and residue on ignition. Full testing to the USP Ursodiol monograph is available and quoted.

What's reported

Purity, as percent of total peak area
Quantity, against the label claim
Identity, reported as match or no match against the reference standard
With monograph testing (quoted): the monograph’s tests against its limits

Tests and prices

Purity and quantity

$250

Chromatographic purity and mg per unit by the method matched to the compound, identity against a reference standard. 1 unit.

Raw powder purity

$200

Chromatographic purity on bulk powder. 50 mg.

Add-on tests

Add-on test	Price
Identity and impurities
FTIR identity	$90
CHNS elemental analysis (carbon, hydrogen, nitrogen, sulfur)	$125
Chiral purity (where a chiral method exists; new methods quoted)	$250
Water, solvents and salt form
Water content by Karl Fischer	$60
Residual solvents	$150
Counterions: chloride, acetate and TFA	$70
Assay
Assay, % w/w (with raw powder purity; $250 together)	+$50
Metals and conformity
Heavy metals: arsenic, cadmium, chromium, mercury and lead	$150
Conformity: purity and quantity on more units from the same lot	$100 per extra unit
Microbiology (injectables)
Endotoxin	$210
Sterility or bioburden	$150
Container closure integrity (CCI)	$50
Screening
Fentanyl screen	$50

10% off for 10 or more samples.

Need something else? Other tests are available on request.

Sample amount and turnaround

Purity and quantity is $250 per sample (1 unit) and raw powder purity is $200 for 50 mg, with results in 3 to 5 business days. Send the material sealed and labeled, with the label claim and the form it contains.

Salts, forms and compendial references

Ursodiol (CAS 128-13-2)
Tell us the salt or form the label states, so quantity is reported on the same basis.

Questions about Ursodiol testing

Is the $250 test the same as USP monograph testing?

No. The $250 test covers identity, purity and quantity by a chromatographic assay, with detection selected for the compound. Full testing to the USP Ursodiol monograph is available and quoted.

What impurities does the ursodiol monograph look for?

Chenodiol (its 7α epimer) and lithocholic acid are the named related compounds. Chenodiol has the same mass as ursodiol, so it must be separated by chromatography.

Why is a standard UV detector not used for ursodiol?

Ursodiol has almost no UV chromophore, so the lab uses a detection method suited to the compound.

Sources

https://pubchem.ncbi.nlm.nih.gov/compound/31401

Identity facts from the USP monograph header for this compound.

Order

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