Description

Pregna-1,4-Diene-3,20-Dione, 6,9-Difluoro-11-Hydroxy-16-Methyl-21-(1-Oxobutoxy)-, (6α,11β,16α)- is a high-purity synthetic corticosteroid derivative of significant pharmaceutical importance. This compound serves as a critical advanced intermediate or active pharmaceutical ingredient (API) in the development and manufacturing of potent topical and systemic anti-inflammatory medications. It is essential for pharmaceutical R&D laboratories, fine chemical synthesis units, and manufacturers specializing in steroid-based therapeutics. The product is supplied under stringent quality control to ensure batch-to-batch consistency for reliable formulation and research outcomes.

Application

• Pharmaceutical Intermediate: Primary use as a key building block in the synthesis of advanced corticosteroid APIs, such as Difluprednate.
• Active Pharmaceutical Ingredient (API): Direct incorporation into final dosage forms for ophthalmic emulsions and topical creams after necessary processing.
• Anti-inflammatory Drug R&D: Critical material for preclinical and clinical research into new steroid-based treatments for ocular inflammation, dermatitis, and post-surgical recovery.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical method development in pharmaceutical laboratories.
• Fine Chemical Synthesis: Used in custom synthesis and process development for creating novel steroid analogues with modified pharmacological profiles.

Basic Information

Product Name	Pregna-1,4-Diene-3,20-Dione, 6,9-Difluoro-11-Hydroxy-16-Methyl-21-(1-Oxobutoxy)-, (6α,11β,16α)-
CAS No.	61633-73-6
Molecular Formula	C₂₆H₃₄F₂O₆
Molecular Weight	480.55 g/mol
Synonyms	Difluprednate; Difluprednate Intermediate; 6α,9α-Difluoro-11β,21-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-butyrate; 6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-(1-oxobutoxy)pregna-1,4-diene-3,20-dione; Durezol (API); 21-Butyryloxy-6α,9α-difluoro-11β-hydroxy-16α-methylpregna-1,4-diene-3,20-dione; (6α,11β,16α)-6,9-Difluoro-11-hydroxy-16-methyl-3-oxopregna-1,4-diene-21-yl butyrate
EINECS	Contact for details

Quality Control

Our Pregna-1,4-Diene-3,20-Dione, 6,9-Difluoro-11-Hydroxy-16-Methyl-21-(1-Oxobutoxy)-, (6α,11β,16α)- is manufactured under GMP-compliant conditions to ensure the highest standards of purity and traceability. Quality is verified through a comprehensive battery of analytical tests including HPLC, NMR, and MS. A detailed Certificate of Analysis (COA) is provided with each batch, confirming identity, purity, and impurity profiles. Our quality system is designed to meet the stringent requirements of pharmaceutical ingredient supply for global markets.

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 the use of desiccants.

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 impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.