Description

Fluticasone Impurity CAS NO 192191-49-4 is a high-purity 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 and pharmaceutical manufacturers for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Fluticasone Propionate and related drug substances.
• Analytical Method Development: Used in HPLC, UPLC, and GC method development and validation to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance: Employed in routine QC testing of active pharmaceutical ingredients (APIs) and finished drug products to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products in fluticasone formulations under various stress conditions.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity fate and tolerance studies.

Basic Information

Product Name	Fluticasone Impurity
CAS No.	192191-49-4
Molecular Formula	C25H31F3O5S
Molecular Weight	500.58 g/mol
Synonyms	Fluticasone Related Compound; Fluticasone Propionate Impurity; S-Fluoromethyl 6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate; 6α,9α-Difluoro-11β,17α-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17β-(fluoromethylthio)acetate; Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-, 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 controlled conditions and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC-MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay	97.0% - 103.0% (on anhydrous basis)

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