Description

6Alpha,9-Difluoro-11Beta-Hydroxy-16Alpha,17-[Isopropylidenebis(Oxy)]Pregna-1,4-Diene-3,20-Dione 21-Propionate is a high-purity synthetic corticosteroid derivative, also known as Difluprednate. This compound is valued for its potent anti-inflammatory and immunosuppressive activity, making it a critical intermediate in advanced pharmaceutical synthesis. It is primarily required by manufacturers in the pharmaceutical industry for the production of ophthalmic and topical corticosteroid medications.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: A key synthetic precursor in the manufacture of the corticosteroid Difluprednate.
• Ophthalmic Drug Formulation: Used in the development of prescription eye drops and ointments for treating post-operative inflammation and pain following ocular surgery.
• Topical Anti-inflammatory Agents: Serves as a core component in the synthesis of creams and lotions for managing inflammatory skin conditions.
• Pharmaceutical Research & Development: Employed in preclinical and clinical studies for novel corticosteroid-based therapies.
• High-Purity Chemical Reference Standard: Supplied as a certified reference material (CRM) for analytical method development and quality control testing in laboratories.

Basic Information

Product Name	6Alpha,9-Difluoro-11Beta-Hydroxy-16Alpha,17-[Isopropylidenebis(Oxy)]Pregna-1,4-Diene-3,20-Dione 21-Propionate
CAS No.	58497-00-0
Molecular Formula	C₂₇H₃₄F₂O₇
Molecular Weight	508.55 g/mol
Synonyms	Difluprednate; Difluprednate Intermediate; 6α,9-Difluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone 21-acetate; 6α,9-Difluoro-11β-hydroxy-16α-methyl-3,20-dioxopregna-1,4-dien-21-yl acetate cyclic 16,17-acetal with acetone; Durezol (Trade Name) Intermediate; NSC 39415
EINECS	Contact for details

Quality Control

Our 6Alpha,9-Difluoro-11Beta-Hydroxy-16Alpha,17-[Isopropylidenebis(Oxy)]Pregna-1,4-Diene-3,20-Dione 21-Propionate is manufactured under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and identity suitable for pharmaceutical applications. Certificates of Analysis (COA) detailing batch-specific results are provided to guarantee traceability and compliance with cGMP and ICH Q7 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider using desiccants.

Specification

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

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