Description

Disodium (8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthrene-11,17-diolate is a high-purity, complex steroidal compound with significant pharmaceutical relevance. This disodium salt form offers enhanced solubility and stability, making it a critical advanced intermediate for the synthesis of potent corticosteroid APIs. It is essential for research and development laboratories and manufacturing facilities focused on next-generation anti-inflammatory and immunosuppressive therapies. Our supply ensures the stringent quality and consistency required for pharmaceutical applications.

Application

• Pharmaceutical Intermediate: A key building block in the multi-step synthesis of high-potency fluorinated corticosteroid active pharmaceutical ingredients (APIs).
• Steroid Research & Development: Used in medicinal chemistry for the discovery and structural modification of novel steroidal compounds with targeted biological activity.
• Reference Standard: Serves as a certified reference material (CRM) for analytical method development, validation, and quality control testing in pharmaceutical analysis.
• Process Chemistry: Employed in scale-up and optimization studies for the commercial manufacturing of steroid-based drugs.
• Biochemical Research: Utilized in studies investigating steroid hormone receptor interactions and metabolic pathways.

Basic Information

Item	Details
Product Name	Disodium (8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthrene-11,17-diolate
CAS No.	7460-03-9
Molecular Formula	C24H29FO7Na2
Molecular Weight	494.47 g/mol
Synonyms	Disodium 9α-Fluoro-11β,17α,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-acetate; Disodium Dexamethasone 21-Acetate; Dexamethasone 21-Acetate Disodium Salt; 9α-Fluoro-16α-methylprednisolone 21-acetate disodium salt; (11β,16α)-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 21-acetate disodium salt; Disodium (11β,16α)-21-(Acetyloxy)-9-fluoro-11,17-dihydroxy-16-methylpregna-1,4-diene-3,20-dionate
EINECS	Contact for details

Quality Control

Our disodium steroid intermediate is manufactured under strict quality management systems. Every batch undergoes comprehensive analytical testing, including HPLC for purity and related substances, IR and NMR for structural confirmation, and stringent tests for residual solvents and heavy metals. We provide full traceability and detailed Certificates of Analysis (COA) to support your regulatory filings and ensure compliance with cGMP, ICH Q7 guidelines, and relevant pharmacopoeial standards.

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. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 3.0%
Residual Solvents (GC)	Meets ICH Q3C limits
Heavy Metals	≤ 20 ppm
Assay (on anhydrous basis)	97.0% - 103.0%

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