Description

Difluprednate is a synthetic corticosteroid ester with potent anti-inflammatory and immunosuppressive properties. This high-purity active pharmaceutical ingredient (API) is critical for the development of advanced ophthalmic and topical formulations. It is primarily utilized by pharmaceutical manufacturers and research institutions focused on innovative therapeutic solutions for inflammatory conditions.

Application

• Ophthalmic Solutions & Suspensions: As the key API in prescription eye drops for treating postoperative inflammation and pain following ocular surgery.
• Topical Creams & Ointments: Formulated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
• Pharmaceutical R&D: Serves as a reference standard and a critical raw material in the research and development of novel anti-inflammatory drugs.
• Veterinary Medicine: Used in the formulation of anti-inflammatory treatments for ocular conditions in animals.
• Analytical Standard: Employed as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical methods.

Basic Information

Product Name	Difluprednate
CAS No.	23674-86-4
Molecular Formula	C27H34F2O7
Molecular Weight	508.55 g/mol
Synonyms	6α,9-Difluoro-11β,17,21-trihydroxy-16-methylenepregna-1,4-diene-3,20-dione 21-acetate 17-butyrate; Durezol; 6α,9-Difluoroprednisolone 17-butyrate 21-acetate; DFB; NSC-39415; Difluprednate (USP); (6α,11β,16α)-6,9-Difluoro-11,17,21-trihydroxy-16-methylenepregna-1,4-diene-3,20-dione 21-acetate 17-butyrate
EINECS	Contact for details

Quality Control

Our Difluprednate is manufactured under strict quality management systems to ensure it meets the stringent requirements for pharmaceutical actives. Each batch is tested against comprehensive specifications, including identity, purity, and impurity profiles, with methods aligned with pharmacopeial standards. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

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% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 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.