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PHR1579

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Ursodiol

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Ursodeoxycholic acid, 3α,7β-Dihydroxy-5β-cholan-24-oic acid, 5β-Cholan-24-oic acid-3α,7β-diol, 7β-Hydroxylithocholic acid, UDCS
Empirical Formula (Hill Notation):
C24H40O4
CAS Number:
128-13-2
Molecular Weight:
392.57
Beilstein:
3219888
EC Number:
204-879-3
MDL number:
MFCD00003680
UNSPSC Code:
41116107
PubChem Substance ID:
329823487
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. U0800000
traceable to USP 1707806

API family

ursodiol

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

203-204 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

C[C@H](CCC(O)=O)[C@H]1CC[C@H]2[C@@H]3[C@@H](O)C[C@@H]4C[C@H](O)CC[C@]4(C)[C@H]3CC[C@]12C

InChI

1S/C24H40O4/c1-14(4-7-21(27)28)17-5-6-18-22-19(9-11-24(17,18)3)23(2)10-8-16(25)12-15(23)13-20(22)26/h14-20,22,25-26H,4-13H2,1-3H3,(H,27,28)/t14-,15+,16-,17-,18+,19+,20+,22+,23+,24-/m1/s1

InChI key

RUDATBOHQWOJDD-UZVSRGJWSA-N

Gene Information

human ... NR1H4(9971)

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General description

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards
Ursodiol is an important bile acid, which can be biologically derived from the epimerization of chenodiol by intestinal bacteria. It is widely used in combination with chenodiol for gall stone dissolution and cholestatic liver diseases.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Ursodiol may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using liquid chromatography technique with fluorigenic derivatization.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC4017 in the slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H315,H319

Hazard Classifications

Eye Irrit. 2 - Skin Irrit. 2

WGK

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Simple and sensitive fluorimetric liquid chromatography for simultaneous analysis of chenodiol and ursodiol in pharmaceutical formulations
Lin CM, et al.
Analytica Chimica Acta, 493(2), 159-166 (2003)

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