Description

Fluticasone Impurity 20 is a high-purity reference standard used in the analytical profiling and quality control of pharmaceutical products. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by accurately identifying and quantifying related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of corticosteroid-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Fluticasone and its derivatives.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control the levels of specified impurities in drug substances and finished products to comply with ICH guidelines.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive identification and characterization data for specified impurities.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track impurity formation over time.
• Research & Development: Utilized in pharmaceutical R&D to understand degradation pathways and synthesis by-products of corticosteroid APIs.

Basic Information

Product Name	Fluticasone Impurity 20
CAS No.	398454-97-2
Molecular Formula	C22H27F3O4S
Molecular Weight	444.51 g/mol
Synonyms	Fluticasone Related Compound; Fluticasone EP Impurity; 6α,9α-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-thienylcarbonyl)oxy]androsta-1,4-diene-17β-carbothioic Acid S-Fluoromethyl Ester Impurity; 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 (8CI); Fluticasone Propionate Related Substance; Contact for details on additional synonyms.
EINECS	Contact for details

Quality Control

Our Fluticasone Impurity 20 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of specific impurities. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications and supporting its use as a reference standard.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive (store away from light).

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.