Description

Fluticasone Impurity 40 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient, Fluticasone. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations containing Fluticasone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fluticasone API and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Fluticasone formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Item	Detail
Product Name	Fluticasone Impurity 40
CAS No.	572880-17-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fluticasone Related Compound 40; Fluticasone EP Impurity 40; Fluticasone USP Impurity 40; 6α,9α-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-furanylcarbonyl)oxy]androsta-1,4-diene-17β-carbothioic Acid S-Fluoromethyl Ester (Related Impurity); Fluticasone Propionate Impurity 40; Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-[(2-furanylcarbonyl)oxy]-, S-(fluoromethyl) ester (Impurity)
EINECS	Contact for details

Quality Control

Our Fluticasone Impurity 40 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies
Residual Solvents (GC)	Complies with ICH guidelines

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