Description

Fluocinolone Acetonide Impurity 2 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, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of a specific impurity in Fluocinolone Acetonide drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods to ensure accurate detection and measurement of impurities.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Utilized as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Fluocinolone Acetonide.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and characterization.
• Research and Development: Supports synthetic chemistry research, metabolism studies, and the investigation of structure-activity relationships (SAR) for corticosteroid analogs.

Basic Information

Product Name	Fluocinolone Acetonide Impurity 2
CAS No.	3830-58-8
Molecular Formula	C24H30F2O6
Molecular Weight	452.49 g/mol
Synonyms	6α,9α-Difluoro-11β,21-dihydroxy-16α,17α-isopropylidenedioxypregna-1,4-diene-3,20-dione; 6α,9α-Difluoro-11β,21-dihydroxy-16α,17α-(isopropylidenedioxy)pregna-1,4-diene-3,20-dione; Fluocinolone Acetonide Related Compound; Fluocinolone Acetonide EP Impurity B; Fluocinolone Acetonide USP Related Compound; 1,4-Pregnadiene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-; (6α,11β,16α)-6,9-Difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione
EINECS	223-322-2

Quality Control

Our Fluocinolone Acetonide Impurity 2 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatograms and spectroscopic data are provided to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
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.