PHR1579

Ursodiol

Pharmaceutical Secondary Standard; Certified Reference Material

• Sinônimo(s): Ursodeoxycholic acid, 3α,7β-Dihydroxy-5β-cholan-24-oic acid, 5β-Cholan-24-oic acid-3α,7β-diol, 7β-Hydroxylithocholic acid, UDCS
• Fórmula empírica (Notação de Hill): C₂₄H₄₀O₄
• Número CAS: 128-13-2
• Peso molecular: 392.57
• Beilstein: 3219888
• Número CE: 204-879-3
• Número MDL: MFCD00003680
• Código UNSPSC: 41116107
• ID de substância PubChem: 329823487
• NACRES: NA.24

Propriedades

• grau: certified reference material; pharmaceutical secondary standard
• Nível de qualidade: 300
• Agency: traceable to Ph. Eur. U0800000; traceable to USP 1707806
• família API: ursodiol
• Certificado de análise (CofA): current certificate can be downloaded
• embalagem: pkg of 500 mg
• técnica(s): HPLC: suitable; gas chromatography (GC): suitable
• pf: 203-204 °C (lit.)
• aplicação(ões): pharmaceutical (small molecule)
• Formato: neat
• temperatura de armazenamento: 2-30°C
• cadeia de caracteres SMILES: 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
• chave InChI: RUDATBOHQWOJDD-UZVSRGJWSA-N
• Informações sobre genes: human ... NR1H4(9971)

Descrição

Descrição geral

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.

Aplicação

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.

Nota de análise

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

Outras notas

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.

Nota de rodapé

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.

Informações de segurança

• Pictogramas: GHS07
• Palavra indicadora: Warning
• Frases de perigo: H315,H319
• Declarações de precaução: P264 - P280 - P302 + P352 - P305 + P351 + P338 - P332 + P313 - P337 + P313
• Classificações de perigo: Eye Irrit. 2 - Skin Irrit. 2
• Código de classe de armazenamento: 11 - Combustible Solids
• Classe de risco de água (WGK): WGK 2
• Ponto de fulgor (°F): Not applicable
• Ponto de fulgor (°C): Not applicable