Description

6Alpha,9-Difluoro-11Beta,21-Dihydroxy-16Alpha,17-(Isopropylidenedioxy)Pregn-4-Ene-3,20-Dione 21-Acetate is a high-purity synthetic corticosteroid intermediate, also known as Difluprednate Impurity C. This compound is of critical importance for ensuring the quality and regulatory compliance of pharmaceutical active ingredients. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development, quality control, and production of steroidal anti-inflammatory drugs.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for analytical method development, validation, and quality control testing of Difluprednate API and finished dosage forms.
• Impurity Profiling: Used for the identification and quantification of process-related impurities and degradation products in steroidal drug substances, crucial for regulatory filings (e.g., ICH guidelines).
• Research & Development: A key intermediate or starting material in synthetic organic chemistry research for novel corticosteroid analogs and prodrug development.
• GMP Manufacturing: Employed in the synthesis and scale-up of high-potency topical corticosteroids under controlled Good Manufacturing Practice (GMP) environments.
• Stability Studies: Utilized as a marker compound in forced degradation and long-term stability studies to understand drug product behavior.
• Metabolite Studies: Acts as a relevant standard in pharmacokinetic and metabolic pathway research for related corticosteroid compounds.

Basic Information

Product Name	6Alpha,9-Difluoro-11Beta,21-Dihydroxy-16Alpha,17-(Isopropylidenedioxy)Pregn-4-Ene-3,20-Dione 21-Acetate
CAS No.	3932-49-8
Molecular Formula	C₂₆H₃₂F₂O₇
Molecular Weight	494.53 g/mol
Synonyms	Difluprednate Impurity C; Difluprednate Related Compound C; 6α,9α-Difluoro-11β,21-dihydroxy-16α,17α-(isopropylidenedioxy)pregn-4-ene-3,20-dione 21-acetate; 21-Acetoxy-6α,9α-difluoro-11β-hydroxy-16α,17α-isopropylidenedioxypregn-4-ene-3,20-dione; Pregna-4-ene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11,17-dihydroxy-16-methyl-, (6α,11β,16α)-, cyclic 16,17-acetal with acetone; Difluprednate EP Impurity C
EINECS	Contact for details

Quality Control

Our high-purity pharmaceutical intermediate is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets exacting standards for use as a reference standard. Certificates of Analysis (COA) detailing all test results are provided and can be tailored to support specific pharmacopeial requirements (e.g., USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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