Description

Fluticasone Impurity CAS NO 948565-92-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing Fluticasone. It is primarily required by analytical laboratories, quality control departments, and research institutions within the global pharmaceutical and biotechnology sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Fluticasone Propionate and related drug substances and products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, ensuring accurate impurity detection.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to monitor impurity levels and ensure drug product specifications are met.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurities as required by ICH guidelines Q3A(R2) and Q3B(R2).
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and behavior of this impurity under various stress conditions.
• Research and Development: Used in synthetic chemistry and pharmacology R&D to study the metabolic pathways, degradation mechanisms, and toxicological profiles associated with Fluticasone.

Basic Information

Product Name	Fluticasone Impurity
CAS No.	948565-92-2
Molecular Formula	C22H27F3O4S
Molecular Weight	444.51 g/mol
Synonyms	Fluticasone Related Compound; Fluticasone Propionate Impurity; 6α,9α-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-thiophenecarbonyl)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 EP Impurity; Fluticasone USP Impurity
EINECS	Contact for details

Quality Control

Our Fluticasone Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. The container should be opened under dry, inert conditions when possible.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
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.