Description

Fluticasone Impurity 5 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Fluticasone. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality control processes in the production of corticosteroid-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Fluticasone Impurity 5 in Fluticasone Propionate API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine analysis to ensure API and drug product batches meet stringent pharmacopeial (USP, EP, ICH) impurity limits.
• Stability Studies: Employed to monitor the formation of degradation products in Fluticasone formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and develop purification processes.

Basic Information

Product Name	Fluticasone Impurity 5
CAS No.	192191-51-8
Molecular Formula	C25H31F3O5S
Molecular Weight	500.58 g/mol
Synonyms	Fluticasone Related Compound E; 6α,9-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-thienylcarbonyl)oxy]androsta-1,4-diene-17β-carbothioic Acid S-Fluoromethyl Ester; Fluticasone Propionate Impurity E; Fluticasone EP Impurity E; Fluticasone USP Impurity E; Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-[(2-thienylcarbonyl)oxy]-, S-(fluoromethyl) Ester; Fluticasone Impurity E (EP)
EINECS	Contact for details

Quality Control

Every batch of Fluticasone Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing via advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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