Description

Fluticasone Impurity 17 is a specified impurity and reference standard used in the analytical profiling and quality control of Fluticasone, a potent synthetic corticosteroid. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug substance. It is primarily required for method development, validation, and routine batch testing in the production of Fluticasone-based pharmaceutical products.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Fluticasone Impurity 17 in active pharmaceutical ingredients (APIs).
• Analytical Method Development: Used in developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies of Fluticasone to understand degradation pathways.
• Research & Development: Used in synthetic chemistry R&D for route scouting and process optimization to minimize the formation of this specific impurity.

Basic Information

Product Name	Fluticasone Impurity 17
CAS No.	397864-63-0
Molecular Formula	C22H27F3O4S
Molecular Weight	444.51 g/mol
Synonyms	Fluticasone Related Compound H; Fluticasone EP Impurity H; Fluticasone USP Impurity H; 6α,9α-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-thienylcarbonyl)oxy]androsta-1,4-diene-17β-carbothioic Acid S-Fluoromethyl Ester; Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-[(2-thienylcarbonyl)oxy]-, S-(fluoromethyl) Ester, (6α,11β,16α,17α)-; Fluticasone Propionate Impurity H
EINECS	Contact for details

Quality Control

Our Fluticasone Impurity 17 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from tests including identification (HPLC, IR), assay (by HPLC), and related substance analysis. We support compliance with ICH guidelines and relevant pharmacopoeial standards (USP, EP). Certificates of Analysis are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.