Description

(16α)-9-Fluoro-16,17,21-Trihydroxy-Pregna-1,4-Diene-3,11,20-Trione 16, 21-Diacetate is a high-purity synthetic corticosteroid intermediate of significant importance in pharmaceutical manufacturing. This compound is valued for its role as a key precursor in the synthesis of potent anti-inflammatory and immunosuppressive steroid APIs. It is primarily required by advanced pharmaceutical R&D laboratories and production facilities focused on developing and scaling up corticosteroid-based therapeutics. The product is supplied with rigorous quality control to ensure batch-to-batch consistency for critical process chemistry.

Application

• Pharmaceutical Intermediate: A critical building block in the multi-step synthesis of advanced corticosteroid drugs, including topical and systemic formulations.
• Anti-inflammatory Drug Research: Used in R&D for developing new glucocorticoid receptor agonists with targeted therapeutic profiles.
• Reference Standard: Serves as a high-purity chemical reference standard (CRS) for analytical method development and quality control in API manufacturing.
• Process Chemistry & Scale-Up: Employed in process optimization and pilot-scale production runs for established steroid pharmaceuticals.
• Biochemical Research: Utilized in academic and industrial research to study steroid hormone action, metabolism, and structure-activity relationships (SAR).

Basic Information

Product Name	(16α)-9-Fluoro-16,17,21-Trihydroxy-Pregna-1,4-Diene-3,11,20-Trione 16, 21-Diacetate
CAS No.	1868-22-0
Molecular Formula	C₂₅H₂₉FO₈
Molecular Weight	476.50 g/mol
Synonyms	9α-Fluoro-16α,17α,21-Trihydroxypregna-1,4-diene-3,11,20-trione 16,21-Diacetate; Fluocinolone Acetonide 16,21-Diacetate Intermediate; 9α-Fluoro-16α-hydroxy-1,4-pregnadiene-3,11,20-trione-16,21-diacetate; 16α,21-Diacetoxy-9α-fluoro-11β,17α-dihydroxypregna-1,4-diene-3,20-dione; 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione 16,21-diacetate; 16α,21-Diacetate of Fluocinolone; 1868-22-0; Fluocinolone precursor
EINECS	Contact for details

Quality Control

Our (16α)-9-Fluoro-16,17,21-Trihydroxy-Pregna-1,4-Diene-3,11,20-Trione 16, 21-Diacetate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation, to ensure it meets exacting specifications for pharmaceutical intermediate use. Certificates of Analysis (COA) detailing all test results are provided with every shipment. We support compliance with cGMP and ICH guidelines for pharmaceutical starting materials.

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 light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and opened under conditions of low humidity to prevent degradation. For long-term storage, consider using 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 ≤ 1.0%
Loss on Drying	≤ 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.