PHR1579

Ursodiol

Pharmaceutical Secondary Standard; Certified Reference Material

• 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

Properties

• 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)

Description

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.

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H315 - H319
• Precautionary Statements: P264 - P280 - P302 + P352 - P305 + P351 + P338 - P332 + P313 - P337 + P313
• Hazard Classifications: Eye Irrit. 2 - Skin Irrit. 2
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable