Description

Fluocinolone Acetonide Ep Impurity L is a high-purity reference standard specifically used in the analytical profiling and quality control of the active pharmaceutical ingredient Fluocinolone Acetonide. This compound is critical for ensuring the safety and efficacy of corticosteroid-based pharmaceutical formulations by enabling the accurate identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies focused on method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating test methods.
• Impurity Identification and Profiling: Used in HPLC, UPLC, and LC-MS analyses to identify, characterize, and quantify the Ep impurity in Fluocinolone Acetonide drug substance and finished products.
• Method Development and Validation: Critical for developing and validating stability-indicating assay methods as per ICH Q2(R1) guidelines.
• Quality Control and Batch Release: Employed in routine QC testing to ensure drug substance and product batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Used to monitor the formation of this specific degradation product under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC documentation) to demonstrate control over the impurity profile.

Basic Information

Product Name	Fluocinolone Acetonide Ep Impurity L
CAS No.	1893-65-8
Molecular Formula	C24H30F2O6
Molecular Weight	452.49 g/mol
Synonyms	6α,9α-Difluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone; Fluocinolone Acetonide EP Impurity L; Fluocinolone Acetonide Related Compound L; (6α,11β,16α)-6,9-Difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione; 1,4-Pregnadiene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-; Fluocinolone acetonide impurity L
EINECS	Contact for details

Quality Control

Every batch of Fluocinolone Acetonide Ep Impurity L is manufactured and analyzed under strict quality management systems. The material undergoes rigorous identity confirmation and purity analysis using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS, IR) techniques to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each lot, detailing purity, assay, and chromatographic profile. Our quality commitment aligns with the principles of cGMP and relevant ICH guidelines.

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 low-humidity environment to prevent degradation. For long-term storage, consider desiccation.

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%
Assay	95.0% - 105.0% (on dried basis)
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 1.0%

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