Description

(11,16A)- 9-Fluoro-11-Hydroxy-16,17-[(1-Methylethylidene)Bis(Oxy)]-3,20-Dioxopregna-1,4-Dien-21-Oic Acid is a high-purity synthetic corticosteroid derivative, a key intermediate in advanced pharmaceutical synthesis. Its value lies in its precise molecular structure, which is critical for developing potent anti-inflammatory and immunosuppressive active pharmaceutical ingredients (APIs). This compound is essential for B2B customers in the pharmaceutical and fine chemical industries engaged in the research, development, and commercial-scale production of modern steroid-based therapeutics.

Application

• Pharmaceutical Intermediate: Primary use as a crucial building block in the multi-step synthesis of potent topical and systemic corticosteroids.
• Active Pharmaceutical Ingredient (API) Development: Serves as a core scaffold for the research and development of novel anti-inflammatory drugs targeting specific receptors.
• Process Chemistry & Scale-Up: Used in process optimization and pilot-scale manufacturing for established steroid APIs, ensuring supply chain reliability.
• Reference Standard: Functions as a high-purity analytical standard for quality control (QC) and regulatory compliance testing in pharmaceutical laboratories.
• Biochemical Research: Employed in academic and industrial research to study glucocorticoid receptor interactions and metabolic pathways.

Basic Information

Product Name	(11,16A)- 9-Fluoro-11-Hydroxy-16,17-[(1-Methylethylidene)Bis(Oxy)]-3,20-Dioxopregna-1,4-Dien-21-Oic Acid
CAS No.	53962-41-7
Molecular Formula	C26H31FO7
Molecular Weight	474.52 g/mol
Synonyms	9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone; Difluprednate Impurity; Difluprednate Intermediate; 9α-Fluoro-11β-hydroxy-16α,17α-isopropylidenedioxy-3,20-dioxopregna-1,4-dien-21-oic acid; (11β,16α)-9-Fluoro-11,16,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone; Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-; 53962-41-7
EINECS	Contact for details

Quality Control

Our production of this pharmaceutical intermediate adheres to stringent cGMP (Current Good Manufacturing Practice) guidelines to ensure batch-to-batch consistency and traceability. Quality is verified through comprehensive analytical testing, including HPLC for purity and impurity profiling, identity confirmation by spectroscopic methods, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting all critical quality attributes to support your regulatory filings and quality assurance protocols.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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