Description

Fluticasone Impurity 27 is a specified impurity and degradation product of the active pharmaceutical ingredient Fluticasone, a potent synthetic corticosteroid. This compound is critical for pharmaceutical research and development, serving as a key reference standard in analytical method development and validation to ensure drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for impurity profiling, stability studies, and compliance with stringent ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Fluticasone-related impurities in drug substances and finished products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products in Fluticasone formulations under various stress conditions.
• Quality Control & Assurance: A critical tool for in-process testing and release testing of Fluticasone propionate to meet pharmacopeial standards (USP, EP).
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer forms of the active pharmaceutical ingredient.

Basic Information

Product Name	Fluticasone Impurity 27
CAS No.	1374153-88-4
Molecular Formula	C22H27F3O4S
Molecular Weight	444.51 g/mol
Synonyms	Fluticasone Related Compound 27; Fluticasone Propionate Impurity 27; 6α,9-Difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioic Acid S-(Fluoromethyl) Ester Impurity; Androsta-1,4-diene-17-carbothioic Acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-[(fluoromethyl)thio]carbonyl-, (6α,11β,16α,17α)-; Fluticasone EP Impurity G; Fluticasone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Fluticasone Impurity 27 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality system is designed to meet the needs of pharmaceutical development, with testing typically including HPLC purity, related substances, residual solvents, and spectroscopic confirmation (IR, NMR, MS). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and traceability.

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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
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.