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Pharmaceutical Chemistry
Fluocinolone Acetonide
Formula:
C24H30F2O6
GOST/CAS:
CAS 67-73-2
Fluocinolone acetonide is a highly potent synthetic fluorinated glucocorticosteroid (GCS) with high lipophilicity. The substance occurs as a white or almost white, odorless crystalline powder. It exhibits powerful anti-inflammatory, antiallergic, antipruritic, and vasoconstrictive activities. Fluocinolone acetonide is an indispensable active pharmaceutical ingredient (API) for the production of a wide range of topical dosage forms in the modern Pharma & Personal Care industry.
Applications
Ointment and Cream Production: Utilized as the primary active ingredient (in concentrations of 0.01%–0.025%) to formulate classic, dense ointment and cream bases (e.g., "Synaflan", "Flucinar") indicated for the treatment of dry, scaly, and chronic forms of dermatoses.
Gel and Lotion Manufacturing: Applied in formulations of lightweight topical agents designed for treating weeping (moist) inflammatory lesions, as well as for application on sensitive or thin epidermal areas.
Pharmaceutical Solutions and Shampoos: Incorporated into specialized liquid trichological and dermatological vehicles (shampoos, drops, oils) for managing inflammatory scalp disorders, such as seborrheic dermatitis.
Specialized Medical Devices: Investigated and utilized as an active component in implantable drug delivery systems and long-acting intravitreal implants within the field of ophthalmology.
Key Advantages
High Topical Potency: The incorporation of fluorine atoms into the steroid nucleus significantly enhances its affinity for glucocorticoid receptors, ensuring a robust therapeutic effect even at minimal dosages.
Rapid Symptom Relief: Powerfully suppresses the release of inflammatory mediators and blocks the migration of macrophages and leukocytes, instantly reducing edema, hyperemia, pruritus, and burning sensations at the affected sites.
Optimal Lipophilicity: Due to its physicochemical characteristics, the substance penetrates the stratum corneum of the epidermis effectively and accumulates within it, creating a stable therapeutic depot directly in the inflammatory focus.
Technological Versatility: The powder remains highly stable when integrated into both hydrophilic and lipophilic bases, allowing seamless deployment across various manufacturing and processing lines.
Storage & Transportation
- Store in dry, clean, light-protected, and moisture-proof warehouses, strictly in the tightly sealed original manufacturer's packaging.
- Recommended storage temperature: 15 °C to 30 °C (controlled room temperature). Protect from excessive heat.
- Handle with care using appropriate personal protective equipment (PPE) for skin and respiratory protection, as the substance possesses high biological activity.
- Transportation is permitted via all types of covered transport vehicles, strictly adhering to the regulations governing the transport of fine chemical and pharmaceutical powders.
Technical Specifications
Appearance
White or almost white crystalline powder
Melting Point
267 °C – 269 °C
Assay (Dried Basis)
97.0% – 102.0%
Specific Optical Rotation
+98° to +108°
Loss on Drying
Not more than 1.0%
Organic Impurities
Complies with regulatory requirements
Supply info
- The API powder is supplied in specialized, airtight, double-layer polyethylene bags packed inside fiber drums with a net weight of 25 kg (or in smaller customized packaging for laboratory requirements upon agreement).
- Every batch is accompanied by a comprehensive documentation package: Certificate of Analysis (COA), MSDS, and a GMP quality passport.