Description

Fluorometholone Impurity 4 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety and efficacy of the corticosteroid drug Fluorometholone by enabling the accurate identification, quantification, and control of related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on pharmaceutical impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Fluorometholone and its related substances.
• Impurity Profiling & Method Development: Used in the development and validation of analytical methods, such as HPLC and UPLC, for impurity identification and characterization.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing of Fluorometholone Active Pharmaceutical Ingredients (APIs) and finished drug products to monitor impurity levels against regulatory thresholds.
• Regulatory Compliance & Submission: Critical for preparing documentation required by regulatory bodies (e.g., FDA, EMA) to demonstrate control over the drug substance's impurity profile.
• Stability Studies: Used as a marker to track the formation of degradation products in Fluorometholone formulations under various stress conditions.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthesis routes for Fluorometholone.

Basic Information

Product Name	Fluorometholone Impurity 4
CAS No.	110664-42-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Fluorometholone Related Compound 4; Fluorometholone EP Impurity D; Fluorometholone USP Impurity; 9-Fluoro-11β,17-dihydroxy-6α-methyl-3,20-dioxopregna-1,4-dien-21-yl acetate impurity; 6α-Methyl-9α-fluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate impurity; Fluorometholone Specified Impurity; Fluorometholone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Fluorometholone Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH guidelines. Our quality commitment ensures this reference standard meets the exacting requirements for pharmaceutical impurity analysis.

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 material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and handled under conditions that minimize exposure to light and atmospheric humidity to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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