PHR1702

Fluticasone Propionate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Fluticasone propionate, (6α,11β,16α,17α)-6,9-Difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-(fluoromethyl) ester
• Empirical Formula (Hill Notation): C₂₅H₃₁F₃O₅S
• CAS Number: 80474-14-2
• Molecular Weight: 500.57
• MDL number: MFCD00866007
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823565
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 587; traceable to Ph. Eur. Y0000284; traceable to USP 1285873
• API family: fluticasone
• CofA: current certificate can be downloaded
• packaging: pkg of 200 mg
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: CCC(=O)O[C@@]1([C@H](C)C[C@H]2[C@@H]3C[C@H](F)C4=CC(=O)C=C[C@]4(C)[C@@]3(F)[C@@H](O)C[C@]12C)C(=O)SCF
• InChI: 1S/C25H31F3O5S/c1-5-20(31)33-25(21(32)34-12-26)13(2)8-15-16-10-18(27)17-9-14(29)6-7-22(17,3)24(16,28)19(30)11-23(15,25)4/h6-7,9,13,15-16,18-19,30H,5,8,10-12H2,1-4H3/t13-,15+,16+,18+,19+,22+,23+,24+,25+/m1/s1
• InChI key: WMWTYOKRWGGJOA-CENSZEJFSA-N
• Gene Information: human ... NR3C1(2908)

Description

General description

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.
Fluticasone Propionate, a neutral, highly potent trifluorinated corticosteroid, is a component of aqueous nasal sprays. It shows potent topical anti-inflammatory activity and is highly efficient in suppressing the nasal symptoms associated with rhinitis and asthma.

Application

Fluticasone Propionate may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples by various chromatography techniques.

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 Actions

Fluticasone propionate is a second generation glucocorticoid. Used as an anti-inflammatory agent for asthma. Shown to enhance eosinophil apoptosis in a concentration-dependent manner via the glucocorticoid receptor.

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 LRAB9941 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Pictograms: GHS08
• Signal Word: Warning
• Hazard Statements: H361f,H373
• Precautionary Statements: P202 - P260 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Repr. 2 - STOT RE 2
• Target Organs: Endocrine system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable