Description

Fluocinolone Acetonide Impurity 4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient, Fluocinolone Acetonide. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Fluocinolone Acetonide drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Essential for in-house quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) as part of drug stability programs.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify specifications.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the active ingredient.

Basic Information

Product Name	Fluocinolone Acetonide Impurity 4
CAS No.	389119-98-6
Molecular Formula	C24H30F2O6
Molecular Weight	452.49 g/mol
Synonyms	6α,9-Difluoro-11β,21-dihydroxy-16α,17-(1-methylethylidene)bis(oxy)pregna-1,4-diene-3,20-dione; Fluocinolone Acetonide Related Compound; Fluocinolone Acetonide Degradant; Fluocinolone Acetonide Process Impurity; 6α,9α-Difluoro-11β,21-dihydroxy-16α,17α-isopropylidenedioxypregna-1,4-diene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of Fluocinolone Acetonide Impurity 4 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and light-sensitive; ensure containers are sealed tightly after each use to prevent degradation from moisture and light exposure.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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