Fluocinonide is a synthetic, highly potent fluorinated corticosteroid used primarily as a topical glucocorticoid for the treatment of inflammatory and pruritic skin conditions. It is chemically related to fluocinolone acetonide and contains two fluorine atoms in its corticosteroid structure.
Fluocinonide has the molecular formula C₂₆H₃₂F₂O₇, molecular weight 494.52 g/mol, and CAS Registry Number 356-12-7. The USP monograph identifies the substance as 6α,9-difluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione, cyclic 16,17-acetal with acetone, 21-acetate.
Fluocinonide is used in topical pharmaceutical preparations for inflammatory and pruritic dermatological conditions. It is a potent topical corticosteroid and is marketed in products such as creams, ointments, gels and solutions depending on the market and formulation.
Fluocinonide acts through glucocorticoid receptors. Activation of these receptors modifies the expression of inflammatory mediators, thereby reducing inflammation, erythema, itching and other manifestations of inflammatory skin disorders.
The Japanese Pharmacopoeia describes Fluocinonide as white crystals or crystalline powder. It is practically insoluble in water, sparingly soluble in chloroform and slightly soluble in acetonitrile, methanol, ethanol and ethyl acetate. It also exhibits crystal polymorphism.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |