Description

Fludrocortisone CAS NO 127-31-1 is a synthetic fluorinated corticosteroid with potent mineralocorticoid activity. This compound is a critical active pharmaceutical ingredient (API) for the formulation of life-sustaining hormone replacement therapies. It is primarily required by the global pharmaceutical industry for the production of medications used to treat adrenal insufficiency, such as Addison's disease, and certain forms of salt-losing adrenogenital syndrome.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral tablets and injectable formulations for adrenal insufficiency.
• Hormone Replacement Therapy (HRT): Essential for managing conditions like Addison's disease and congenital adrenal hyperplasia where the body cannot produce sufficient natural corticosteroids.
• Reference Standard: Serves as a high-purity analytical standard in pharmaceutical quality control laboratories for HPLC, LC-MS, and other assay methods.
• Research & Development: Used in preclinical and clinical studies investigating corticosteroid pharmacology, receptor binding, and metabolic pathways.
• Veterinary Medicine: Employed in formulations for treating adrenal disorders in companion animals and livestock.

Basic Information

Product Name	Fludrocortisone
CAS No.	127-31-1
Molecular Formula	C21H29FO5
Molecular Weight	380.45 g/mol
Synonyms	9α-Fluorocortisol; 9α-Fluoro-11β,17α,21-trihydroxypregn-4-ene-3,20-dione; Florinef; Astonin-H; Fludrocortisonum; Fluohydrocortisone; Fluorohydrocortisone; 9α-Fluorohydrocortisone
EINECS	204-841-4

Quality Control

Our Fludrocortisone is manufactured under strict quality management systems. Each batch is tested to meet stringent specifications for identity, purity, and potency, aligning with major pharmacopoeial standards. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological limits is provided with every shipment to ensure traceability and regulatory compliance.

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 dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Water (KF Titration)	≤ 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.