Description

9Beta,11Beta-Epoxy-6Alpha-Fluoro-17,21-Dihydroxy-16Beta-Methylpregna-1,4-Diene-3,20-Dione is a high-purity synthetic steroid intermediate of significant importance in advanced pharmaceutical manufacturing. This compound is valued for its role as a key precursor in the synthesis of potent corticosteroid APIs, enabling the development of targeted anti-inflammatory and immunosuppressive therapies. It is primarily required by pharmaceutical R&D laboratories and production facilities focused on developing next-generation steroid-based medications.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of advanced corticosteroid active pharmaceutical ingredients (APIs).
• Anti-inflammatory Drug Development: Used in research and production of novel glucocorticoid receptor agonists for treating inflammatory and autoimmune conditions.
• Steroid Chemistry Research: Serves as a valuable reference standard and starting material for academic and industrial research in medicinal chemistry.
• Process Development: Employed in the scale-up and optimization of synthetic routes for complex steroid molecules.
• GMP Manufacturing: Suitable for use in cGMP-compliant production environments for regulated pharmaceutical products.

Basic Information

Product Name	9Beta,11Beta-Epoxy-6Alpha-Fluoro-17,21-Dihydroxy-16Beta-Methylpregna-1,4-Diene-3,20-Dione
CAS No.	82662-44-0
Molecular Formula	C22H27FO6
Molecular Weight	406.45 g/mol
Synonyms	6α-Fluoro-9β,11β-epoxy-16β-methylpregna-1,4-diene-3,20-dione-17,21-diol; 9β,11β-Epoxy-6α-fluoro-16β-methyl-1,4-pregnadiene-17α,21-diol-3,20-dione; 6α-Fluoro-9β,11β-epoxy-16β-methyl-1,4-pregnadiene-17α,21-diol-3,20-dione; 16β-Methyl-9β,11β-epoxy-6α-fluoro-1,4-pregnadiene-17α,21-diol-3,20-dione; Difluprednate Intermediate; Difluprednate EP Impurity C; Steroid Epoxide Intermediate
EINECS	Contact for details

Quality Control

Our 9Beta,11Beta-Epoxy-6Alpha-Fluoro-17,21-Dihydroxy-16Beta-Methylpregna-1,4-Diene-3,20-Dione is manufactured under strict quality management systems to ensure batch-to-batch consistency and high purity. The product undergoes rigorous analytical testing, including HPLC, NMR, and MS, to confirm identity and purity. Certificates of Analysis (COA) detailing all specifications are provided with each shipment. We support development and commercial projects requiring compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability. For long-term storage, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%
Heavy Metals	≤ 20 ppm

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