PHR1579

Ursodiol

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(e): Ursodesoxycholsäure, 3α,7β-Dihydroxy-5β-cholan-24-säure, 5β-Cholan-24-säure-3α,7β-diol, 7β-Hydroxylithocholisäure, UDCS
• Empirische Formel (Hill-System): C₂₄H₄₀O₄
• CAS-Nummer: 128-13-2
• Molekulargewicht: 392.57
• Beilstein: 3219888
• EG-Nummer: 204-879-3
• MDL-Nummer: MFCD00003680
• UNSPSC-Code: 41116107
• PubChem Substanz-ID: 329823487
• NACRES: NA.24

Eigenschaften

• Qualität: certified reference material; pharmaceutical secondary standard
• Qualitätsniveau: 300
• Agentur: traceable to Ph. Eur. U0800000; traceable to USP 1707806
• API-Familie: ursodiol
• Analysenzertifikat (CofA): current certificate can be downloaded
• Verpackung: pkg of 500 mg
• Methode(n): HPLC: suitable; gas chromatography (GC): suitable
• mp (Schmelzpunkt): 203-204 °C (lit.)
• Anwendung(en): pharmaceutical (small molecule)
• Format: neat
• Lagertemp.: 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
• InChIKey: RUDATBOHQWOJDD-UZVSRGJWSA-N
• Angaben zum Gen: human ... NR1H4(9971)

Beschreibung

Allgemeine Beschreibung

Certified pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to in-house working standards.

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.

Anwendung

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.

Hinweis zur Analyse

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

Sonstige Hinweise

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.

Fußnote

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.

Sicherheitshinweise

• Piktogramme: GHS07
• Signalwort: Warning
• H-Sätze: H315,H319
• P-Sätze: P264 - P280 - P302 + P352 - P305 + P351 + P338 - P332 + P313 - P337 + P313
• Gefahreneinstufungen: Eye Irrit. 2 - Skin Irrit. 2
• Lagerklassenschlüssel: 11 - Combustible Solids
• WGK: WGK 2
• Flammpunkt (°F): Not applicable
• Flammpunkt (°C): Not applicable