Description

Fluorometholone Acetate 6,9(11)-Diene Impurity is a key process-related impurity and reference standard used in the synthesis and quality control of the corticosteroid Fluorometholone Acetate. This compound is critical for ensuring the purity and safety profile of the active pharmaceutical ingredient (API) by enabling accurate identification and quantification of this specific diene impurity. It is an essential analytical tool for pharmaceutical manufacturers, research laboratories, and regulatory bodies focused on steroid-based ophthalmic and dermatological preparations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of the 6,9(11)-diene impurity in Fluorometholone Acetate API batches.
• Method Development & Validation: Critical for developing and validating analytical methods, particularly HPLC and LC-MS, to monitor process impurities.
• Quality Assurance/Quality Control (QA/QC): Used in in-house quality control laboratories to ensure API purity meets pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products in stability testing of Fluorometholone Acetate drug products.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Process Chemistry Research: Aids synthetic chemists in optimizing manufacturing processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Fluorometholone Acetate 6,9(11)-Diene Impurity
CAS No.	95955-20-7
Molecular Formula	C24H31FO5
Molecular Weight	418.50 g/mol
Synonyms	6,9(11)-Diene-Fluorometholone Acetate; 9,11-Dehydro-Fluorometholone Acetate; (6α,11β)-9,11-Dehydro-6-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-diene-21-yl acetate; Fluorometholone Acetate Diene Impurity; Fluorometholone Acetate Impurity D; Fluorometholone Acetate Related Compound D; 6-Fluoro-11β,17,21-trihydroxy-16-methylpregna-1,4,6,9(11)-tetraene-3,20-dione 21-acetate
EINECS	Contact for details

Quality Control

Every batch of Fluorometholone Acetate 6,9(11)-Diene Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, GC, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. 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 in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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