Description

6Beta,9-Difluoro-11Beta,16Alpha,17,21-Tetrahydroxypregna-1,4-Diene-3,20-Dione 16,21-Di(Acetate) CAS NO 60864-49-5 is a high-purity synthetic corticosteroid derivative, specifically a fluorinated and acetylated pregnadiene. This compound is of significant commercial and research interest as a key pharmaceutical intermediate in the synthesis of potent topical anti-inflammatory agents. It is primarily required by pharmaceutical R&D laboratories and active pharmaceutical ingredient (API) manufacturers for the development and production of advanced dermatological and ophthalmic treatments.

Application

• Pharmaceutical Intermediate: Critical precursor in the multi-step synthesis of high-potency topical corticosteroids such as Difluprednate.
• Active Pharmaceutical Ingredient (API) Manufacturing: Serves as a building block for final API production under current Good Manufacturing Practices (cGMP).
• Research & Development: Used in medicinal chemistry research for developing new steroidal anti-inflammatory drugs with improved efficacy and safety profiles.
• Reference Standard: Employed as an analytical standard in quality control laboratories for method development and impurity profiling.
• Process Chemistry: Utilized in scaling up and optimizing synthetic routes for cost-effective and robust manufacturing processes.

Basic Information

Item	Details
Product Name	6Beta,9-Difluoro-11Beta,16Alpha,17,21-Tetrahydroxypregna-1,4-Diene-3,20-Dione 16,21-Di(Acetate)
CAS No.	60864-49-5
Molecular Formula	C₂₇H₃₄F₂O₈
Molecular Weight	524.55 g/mol
Synonyms	6β,9α-Difluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione 16,21-diacetate; Difluprednate Intermediate; 16α,21-Diacetoxy-6β,9α-difluoro-11β,17-dihydroxypregna-1,4-diene-3,20-dione; 6β,9α-Difluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 16,21-diacetate; 9α,6β-Difluoroprednisolone 16,21-diacetate; NSC 394000; Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,16,17,21-tetrahydroxy-, 16,21-diacetate, (6β,11β,16α)-
EINECS	Contact for details

Quality Control

Our 6Beta,9-Difluoro-11Beta,16Alpha,17,21-Tetrahydroxypregna-1,4-Diene-3,20-Dione 16,21-Di(Acetate) is produced and tested to meet the stringent requirements of pharmaceutical intermediate applications. We employ advanced analytical techniques including HPLC, GC, and NMR to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing specifications for assay, related substances, residual solvents, and other critical parameters. Our quality system is designed to support cGMP compliance for our customers' regulatory filings.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container tightly sealed when not in use to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Loss on Drying	≤ 0.5%
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.