Description

Fluticasone Impurity 18 is a designated process-related impurity and reference standard used in the pharmaceutical development and quality control of Fluticasone, a potent synthetic corticosteroid. This high-purity analytical standard is critical for ensuring the safety, efficacy, and regulatory compliance of Fluticasone-based drug products by enabling accurate identification, quantification, and control of this specific impurity. It is an essential material for analytical laboratories, quality assurance departments, and research scientists working in pharmaceutical manufacturing, regulatory affairs, and method development.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Fluticasone Propionate and related drug substances.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in routine QC testing of active pharmaceutical ingredients (APIs) and finished drug products to monitor and control impurity levels, ensuring they remain within specified safety thresholds.
• Regulatory Compliance & Submission: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and marketing authorization applications.
• Stability Studies: Employed as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Fluticasone formulations.
• Research & Process Chemistry: Aids in understanding the synthetic pathway of Fluticasone, helping to identify the source of impurity formation and optimize manufacturing processes to minimize its generation.

Basic Information

Product Name	Fluticasone Impurity 18
CAS No.	948566-11-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fluticasone Related Compound 18; Fluticasone Propionate Impurity 18; 6α,9α-Difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-[(2-furanylcarbonyl)oxy]androsta-1,4-diene-17β-carbothioic Acid S-Fluoromethyl Ester (Structural Isomer); Fluticasone EP Impurity I; Fluticasone Process Impurity; Androsta-1,4-diene-17-carbothioic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Fluticasone Impurity 18 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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