Description

6Alpha,9-Difluoro-11Beta,17,21-Trihydroxy-16Alpha-Methylpregn-4-Ene-3,20-Dione 21-Pivalate is a high-purity synthetic corticosteroid intermediate of significant importance in pharmaceutical manufacturing. Its core value lies in its role as a key precursor for the synthesis of potent topical anti-inflammatory and anti-pruritic medications, offering manufacturers a reliable building block for complex steroid APIs. This compound is essential for R&D laboratories and production facilities specializing in dermatological corticosteroids, inhalable asthma treatments, and other advanced steroid-based therapies where precise fluorination and esterification are critical for drug potency and pharmacokinetics.

Application

• Active Pharmaceutical Ingredient (API) Intermediate: Primary use as a critical synthetic precursor in the manufacture of modern corticosteroid drugs.
• Dermatological Corticosteroids: Key building block for topical creams, ointments, and lotions used to treat eczema, psoriasis, and dermatitis.
• Respiratory Medicinal Products: Intermediate in the synthesis of inhalable corticosteroids for asthma and chronic obstructive pulmonary disease (COPD) management.
• Veterinary Pharmaceuticals: Used in the development of anti-inflammatory and immunosuppressive treatments for animals.
• Pharmaceutical Research & Development: Serves as a reference standard and starting material for novel steroid analog synthesis in drug discovery programs.
• Process Chemistry & Scale-Up: Employed in process optimization and pilot-scale production for established corticosteroid APIs.

Basic Information

Product Name	6Alpha,9-Difluoro-11Beta,17,21-Trihydroxy-16Alpha-Methylpregn-4-Ene-3,20-Dione 21-Pivalate
CAS No.	70141-41-2
Molecular Formula	C₂₇H₃₆F₂O₆
Molecular Weight	494.57 g/mol
Synonyms	Difluprednate Impurity; Difluprednate Related Compound A; 6α,9α-Difluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-pivalate; 21-(2,2-Dimethylpropanoyloxy)-6α,9α-difluoro-11β,17α-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione; Pregna-1,4-diene-3,20-dione, 21-(2,2-dimethyl-1-oxopropoxy)-6,9-difluoro-11,17-dihydroxy-16-methyl-, (6α,11β,16α)-; 6α,9α-Difluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-pivalate; Difluprednate EP Impurity A
EINECS	Contact for details

Quality Control

Our 6Alpha,9-Difluoro-11Beta,17,21-Trihydroxy-16Alpha-Methylpregn-4-Ene-3,20-Dione 21-Pivalate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing including HPLC for purity, identity confirmation by IR and NMR, and stringent control of related substances and residual solvents to meet pharmaceutical intermediate standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment to ensure traceability and compliance with your internal specifications and regulatory requirements.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Loss on Drying	≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines

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