Description

Fluticasone Impurity CAS NO 785806-96-4 is a high-purity reference standard critical for analytical research and quality control in pharmaceutical development. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in active pharmaceutical ingredients (APIs). It is primarily used by analytical chemists, quality assurance professionals, and research scientists within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Fluticasone API batches.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, and GC analytical methods.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to ensure API purity meets stringent pharmacopeial standards (e.g., USP, EP, ICH).
• Stability Studies: Used to monitor the formation of degradation products in Fluticasone formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research and Development: Facilitates synthetic route optimization and process chemistry studies by tracking impurity formation.

Basic Information

Product Name	Fluticasone Impurity
CAS No.	785806-96-4
Molecular Formula	C22H27F3O4S
Molecular Weight	444.51 g/mol
Synonyms	Fluticasone Related Compound; Fluticasone Process Impurity; 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 EP Impurity; Fluticasone USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Fluticasone Impurity CAS 785806-96-4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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