Description

6Beta,9-Difluoro-11Beta,17,21-Trihydroxy-16Alpha-Methylpregna-1,4-Diene-3,20-Dione is a high-purity synthetic corticosteroid intermediate of significant pharmaceutical importance. This compound is valued for its potent anti-inflammatory and immunosuppressive properties, serving as a critical building block in advanced pharmaceutical synthesis. It is primarily required by research institutions and manufacturers in the pharmaceutical industry for the development and production of next-generation topical and systemic corticosteroid medications.

Application

• Pharmaceutical Intermediate: A key precursor in the synthesis of potent topical corticosteroids like difluprednate and other advanced glucocorticoid receptor agonists.
• Active Pharmaceutical Ingredient (API) Manufacturing: Used in the controlled production of finished dosage forms for anti-inflammatory and immunosuppressive therapies.
• Research & Development: Essential for pharmacological studies, structure-activity relationship (SAR) research, and the development of new steroid-based drugs.
• Ophthalmic Preparations: Employed in the formulation of eye drops and ointments for treating postoperative inflammation and ocular pain.
• Dermatological Products: A critical component in the manufacture of creams and ointments for treating conditions like eczema, psoriasis, and contact dermatitis.
• Process Chemistry: Serves as a standard or reference compound in scaling up synthetic routes and optimizing manufacturing processes under GMP guidelines.

Basic Information

Product Name	6Beta,9-Difluoro-11Beta,17,21-Trihydroxy-16Alpha-Methylpregna-1,4-Diene-3,20-Dione
CAS No.	60895-22-9
Molecular Formula	C₂₂H₂₈F₂O₅
Molecular Weight	410.46 g/mol
Synonyms	Difluprednate Intermediate; 6β,9α-Difluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione; 16α-Methyl-6β,9α-difluoro-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione; 9α,6β-Difluoroprednisolone 16α-methyl; Durezol Intermediate; 60895-22-9; 6β,9α-Difluoro-16α-methylprednisolone
EINECS	Contact for details

Quality Control

Our 6Beta,9-Difluoro-11Beta,17,21-Trihydroxy-16Alpha-Methylpregna-1,4-Diene-3,20-Dione is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and IR spectroscopy, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all specifications. Production can be aligned with cGMP (Current Good Manufacturing Practice) standards for pharmaceutical applications upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to prevent moisture absorption, which may affect stability and purity. Keep away from incompatible materials.

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)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.5% 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.