PHR1842

Fluticasone Related Compound A

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 6ALPHA,9-DIFLUORO-11BETA-HYDROXY- 16ALPHA-METHYL-3-OXO-17 (PROPANOYLOXY)ANDROSTA-1,4-DIEN- 17BETA-CARBO(THIOPEROXOIC)SO-ACID (Fluticasone Related Compound A) (Fluticasone Impurity B), 6ALPHA,9-DIFLUORO-11BETA-HYDROXY- 16ALPHA-METHYL-3-OXO-17 (PROPANOYLOXY)ANDROSTA-1,4-DIEN- 17BETA-CARBO(THIOPEROXOIC)SO-ACID
• Empirical Formula (Hill Notation): C₂₄H₃₀F₂O₆S
• CAS Number: 948566-12-9
• Molecular Weight: 484.55
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• API family: fluticasone
• CofA: current certificate can be downloaded
• packaging: pkg of 50 mg
• format: neat
• storage temp.: 2-8°C

Description

General description

Fluticasone Related Compound B is an impurity of the synthetic corticosteroid drug, fluticasone propionate. Fluticasone propionate is generally used as an inhalation medication for the treatment of asthma.
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.

Application

Fluticasone Related Compound B may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.

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.

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 LRAB2754 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: Danger
• Hazard Statements: H317 - H334
• Precautionary Statements: P261 - P280 - P284 - P304 + P340 - P342 + P311
• Hazard Classifications: Resp. Sens. 1 - Skin Sens. 1
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable