Description

Fluticasone Impurity CAS NO 59860-80-9 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Fluticasone, a potent corticosteroid. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by analytical laboratories, research institutions, and pharmaceutical manufacturers for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Fluticasone drug substances and products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating HPLC, UPLC, and GC methods to meet ICH Q3A/B guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this impurity under various stress conditions.
• Quality Control and Batch Release Testing: Essential for in-house QC laboratories to set specification limits and ensure batch-to-batch consistency of Fluticasone APIs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Research and Development: Used in synthetic chemistry R&D to study the formation pathways and develop purification processes to minimize this impurity.

Basic Information

Product Name	Fluticasone Impurity
CAS No.	59860-80-9
Molecular Formula	C22H27F3O4S
Molecular Weight	444.51 g/mol
Synonyms	Fluticasone Related Compound; 6α,9α-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-thienylcarbonyl)oxy]androsta-1,4-diene-17β-carbothioic Acid S-Fluoromethyl Ester; Fluticasone Propionate Impurity; 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)-; SQ 10651 Impurity
EINECS	Contact for details

Quality Control

Every batch of Fluticasone Impurity CAS 59860-80-9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting cGMP and ICH regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (on dried basis)	97.0% - 103.0%

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