Description

Fluticasone Impurity CAS NO 397864-58-3 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities in Fluticasone drug substances and products. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry, particularly those involved in method development, validation, and regulatory compliance for corticosteroid APIs.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Fluticasone propionate and related corticosteroid active pharmaceutical ingredients (APIs).
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, and GC analytical methods to ensure specificity, accuracy, and robustness.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to ensure product purity and compliance with stringent pharmacopeial standards (USP, EP, ICH).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Stability Studies: Acts as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Fluticasone formulations.
• Research & Development: Utilized in synthetic chemistry R&D to study reaction pathways, optimize processes, and minimize impurity formation during API synthesis.

Basic Information

Product Name	Fluticasone Impurity
CAS No.	397864-58-3
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-17β-carbothioic Acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-[(2-thienylcarbonyl)oxy]-, S-(fluoromethyl) Ester; S-(Fluoromethyl) 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-thiophenecarbonyl)oxy]androsta-1,4-diene-17β-carbothioate
EINECS	Contact for details

Quality Control

Our Fluticasone Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive 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. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specifications and traceability to primary standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. 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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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