Description

Fluticasone Ep Impurity B is a high-purity chemical reference standard critical for pharmaceutical analysis and quality control. This compound serves as a specified impurity in the synthesis and purification of Fluticasone, a potent corticosteroid used in respiratory medications. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method development, validation, and regulatory compliance. Ensuring the integrity of your active pharmaceutical ingredient (API) supply chain depends on access to well-characterized impurities like this one.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and GC-MS analysis of Fluticasone Propionate and related APIs.
• Method Development & Validation: Critical for developing and validating analytical methods to monitor and control impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and finished dosage form producers to ensure batch-to-batch consistency and purity.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiling and identification data for drug master files (DMFs).
• Research & Development (R&D): Employed in synthetic chemistry research to study degradation pathways and optimize purification processes for Fluticasone.
• Contract Research Organizations (CROs): Utilized by third-party testing labs to provide impurity identification and quantification services to pharmaceutical clients.

Basic Information

Product Name	Fluticasone Ep Impurity B
CAS No.	948566-12-9
Molecular Formula	C₂₂H₂₇F₃O₄S
Molecular Weight	444.51 g/mol
Synonyms	Fluticasone EP Impurity B; Fluticasone Related Compound B; (6α,11β,16α,17α)-6,9-Difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)androsta-1,4-diene-17-carbothioic acid S-fluoromethyl ester; Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(1-oxopropoxy)-, S-(fluoromethyl) ester, (6α,11β,16α,17α)-; Fluticasone Propionate EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Fluticasone Ep Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (e.g., EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.