PHR1178

Budesonid

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(e): 16,17-Butylidenbis(oxy)-11,21-dihydroxypregna-1,4-dien-3,20-dion
• Empirische Formel (Hill-System): C₂₅H₃₄O₆
• CAS-Nummer: 51333-22-3
• Molekulargewicht: 430.53
• EG-Nummer: 257-139-7
• MDL-Nummer: MFCD00083259
• UNSPSC-Code: 41116107
• PubChem Substanz-ID: 329823190
• NACRES: NA.24

Eigenschaften

• Qualität: certified reference material; pharmaceutical secondary standard
• Qualitätsniveau: 300
• Agentur: traceable to BP 793; traceable to Ph. Eur. B1157300; traceable to USP 1078201
• API-Familie: budesonide
• Analysenzertifikat (CofA): current certificate can be downloaded
• Methode(n): HPLC: suitable; gas chromatography (GC): suitable
• Anwendung(en): pharmaceutical (small molecule)
• Format: neat
• Lagertemp.: 2-8°C
• SMILES String: [H][C@@]12CCC3=CC(=O)C=C[C@]3(C)[C@@]1([H])[C@@H](O)C[C@@]4(C)[C@@]2([H])C[C@H]5OC(CCC)O[C@@]45C(=O)CO
• InChI: 1S/C25H34O6/c1-4-5-21-30-20-11-17-16-7-6-14-10-15(27)8-9-23(14,2)22(16)18(28)12-24(17,3)25(20,31-21)19(29)13-26/h8-10,16-18,20-22,26,28H,4-7,11-13H2,1-3H3/t16-,17-,18-,20+,21?,22+,23-,24-,25+/m0/s1
• InChIKey: VOVIALXJUBGFJZ-KWVAZRHASA-N
• Angaben zum Gen: human ... NR3C1(2908)

Beschreibung

Allgemeine Beschreibung

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Budesonide is a nonsystemic glucocorticoid and an epimeric mixture, where both the epimers have similar anti-inflammatory activity. It is widely used in the treatment of Crohn′s disease.

Anwendung

Budesonide may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using high-performance liquid chromatography technique.

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.

Biochem./physiol. Wirkung

Budesonid ist ein Glucocorticoid der zweiten Generation mit niedriger systemischer Absorption. Es wird als entzündungshemmendes Mittel in der Behandlung von Asthma, Rhinitis und entzündlichen Darmerkrankungen eingesetzt. Es hemmt die Expression von Chemokin-mRNA und die Produktion von Eotaxin und RANTES-Protein in primären humanen bronchialen Epithelzellen. Budesonid ist derzeit in den klinischen Studien zur Prävention von Lungenkrebs. Es zeigt bei Mäusen hemmende Wirkung auf die Benzo[a]pyren-induzierte Karzinogenese der Lunge.

Hinweis zur Analyse

These secondary standards offer multi-traceability to the USP, EP (PhEur) 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

Die Werte der Analyten sind Lot-spezifisch.

Sicherheitshinweise

• Piktogramme: GHS08,GHS07
• Signalwort: Danger
• H-Sätze: H302,H317,H361d,H372,H412
• P-Sätze: P202 - P273 - P280 - P301 + P312 - P302 + P352 - P308 + P313
• Gefahreneinstufungen: Acute Tox. 4 Oral - Aquatic Chronic 3 - Repr. 2 - Skin Sens. 1 - STOT RE 1 Inhalation
• Zielorgane: Adrenal gland
• Lagerklassenschlüssel: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flammpunkt (°F): Not applicable
• Flammpunkt (°C): Not applicable