Description

Fluorometholone Impurity 5 is a high-purity chemical reference standard, specifically identified as a known impurity of the corticosteroid Fluorometholone. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research institutions, quality assurance laboratories, and API producers to ensure the purity, safety, and regulatory compliance of Fluorometholone-based drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the accurate identification and quantification of Fluorometholone Impurity 5 in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Analytical Method Development and Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity levels throughout the drug product lifecycle.
• Quality Control and Release Testing: Used as a system suitability standard and for preparing calibration curves in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Stability Studies: Employed to track the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability studies.
• Regulatory Submissions: Provides necessary data and reference substances for regulatory filings (e.g., with FDA, EMA) to establish impurity acceptance criteria.
• Research and Development: Utilized in synthetic chemistry R&D to understand degradation pathways and to improve the synthesis process of Fluorometholone to minimize impurity formation.

Basic Information

Product Name	Fluorometholone Impurity 5
CAS No.	110664-58-9
Molecular Formula	C22H29FO4
Molecular Weight	376.46 g/mol
Synonyms	9-Fluoro-11β,17-dihydroxy-6α-methyl-3,20-dioxopregna-1,4-dien-21-yl acetate; Fluorometholone related compound; Fluorometholone Degradant; Fluorometholone EP Impurity; Fluorometholone USP Impurity; 6α-Methyl-9α-fluoro-11β,17α,21-trihydroxy-1,4-pregnadiene-3,20-dione 21-acetate (impurity form)
EINECS	Contact for details

Quality Control

Every batch of Fluorometholone Impurity 5 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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