Description

Fluticasone Furoate Impurity 4 is a specified impurity of the active pharmaceutical ingredient (API) Fluticasone Furoate, a potent corticosteroid. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories in the pharmaceutical industry who require high-purity chemical reference materials to ensure the safety, efficacy, and regulatory compliance of their drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fluticasone Furoate API and finished drug products.
• Analytical Method Development: Critical for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Used to track the formation of degradation products in stability testing of Fluticasone Furoate formulations.
• Research & Development: Facilitates process chemistry research aimed at minimizing the formation of this specific impurity during API synthesis.

Basic Information

Product Name	Fluticasone Furoate Impurity 4
CAS No.	948569-98-0
Molecular Formula	C27H29F3O6S
Molecular Weight	538.58 g/mol
Synonyms	Fluticasone Furoate Related Compound 4; (6α,11β,16α,17α)-6,9-Difluoro-17-{[(fluoromethyl)sulfonyl]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furoate; Fluticasone Impurity FF4; Fluticasone Furoate EP Impurity D; Fluticasone Furoate USP Impurity; 6α,9α-Difluoro-17α-[(fluoromethylthio)carbonyl]-11β-hydroxy-16α-methyl-3-oxoandrosta-1,4-dien-17β-yl furan-2-carboxylate
EINECS	Contact for details

Quality Control

Our Fluticasone Furoate Impurity 4 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), 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. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
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.