Description

Fluticasone Impurity CAS NO 398454-98-3 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Fluticasone. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Fluticasone propionate API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure API and drug product batches meet stringent pharmacopeial (USP, EP, JP) specifications for impurity limits.
• Stability Studies: Used to track the formation and levels of this specific impurity over time under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Fluticasone Impurity
CAS No.	398454-98-3
Molecular Formula	C25H31F3O5S
Molecular Weight	500.58 g/mol
Synonyms	Fluticasone Related Compound; Fluticasone Propionate Impurity; S-Fluoromethyl 6α,9-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-thiophenecarbonyl)oxy]androsta-1,4-diene-17β-carbothioate; Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-[(2-thiophenecarbonyl)oxy]-, S-fluoromethyl ester, (6α,11β,16α,17α)-; Fluticasone EP Impurity; Fluticasone USP Impurity
EINECS	Contact for details

Quality Control

Our Fluticasone Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established specifications. Our quality standards align with ICH guidelines to support your regulatory requirements.

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 must be kept tightly sealed 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 powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.10% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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