Diflucortolone is a synthetic topical glucocorticoid (corticosteroid) used in pharmaceutical dermatological preparations for the management of inflammatory and corticosteroid-responsive skin conditions. It provides anti-inflammatory, antipruritic and vasoconstrictive effects when applied topically.
Diflucortolone is a fluorinated corticosteroid active pharmaceutical ingredient. It is commonly used in topical dermatological formulations, including preparations containing diflucortolone valerate, its ester derivative.
Diflucortolone is identified by CAS No. 2607-06-9. Its molecular formula is C22H29FO5 and its molecular weight is approximately 392.47 g/mol.
Diflucortolone produces corticosteroid activity through interaction with intracellular glucocorticoid receptors. This influences the expression of inflammatory mediators and suppresses inflammatory responses in the skin.
Following topical application and penetration into skin cells, Diflucortolone binds to glucocorticoid receptors. The resulting receptor complex regulates corticosteroid-responsive gene transcription and reduces inflammatory mediator activity.
This results in reduced erythema, swelling, itching and inflammation associated with steroid-responsive dermatoses.
Diflucortolone is associated with topical treatment of corticosteroid-responsive dermatological conditions, including:
The approved indications and formulations may vary according to the country and regulatory authority.
Diflucortolone is relevant to pharmaceutical manufacturers and formulation-development organizations working on topical corticosteroid and dermatological preparations.
The API may be incorporated into creams, ointments or other topical dosage forms according to the approved formulation and applicable regulatory requirements.
Diflucortolone API quality evaluation may include:
Testing should be performed using validated analytical methods appropriate for the API and intended formulation.
Diflucortolone intended for pharmaceutical manufacturing should comply with applicable GMP, quality-control and regulatory requirements.
The final API specification should be established according to the intended market, applicable pharmacopoeial standards and the manufacturer's approved product specification.
A batch-specific Certificate of Analysis (CoA) should provide relevant analytical results and acceptance criteria.
Diflucortolone API should be stored in tightly closed, appropriately labelled packaging under the manufacturer's recommended conditions. Protection from excessive heat, moisture and unsuitable environmental exposure should be maintained.
Diflucortolone is relevant to pharmaceutical companies developing and manufacturing topical dermatological corticosteroid formulations.
For commercial applications, customers should verify the API identity, grade, assay, purity, impurity profile, specification, regulatory documentation and batch-specific CoA before use.
Consistent Diflucortolone API quality is important for reliable formulation development and pharmaceutical manufacturing. Control of identity, assay, purity and related substances supports reproducible product quality.
Appropriate documentation may include a Certificate of Analysis, specification sheet, safety documentation and applicable regulatory information.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| 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 | ≤ 0.5% |
| Water Content | NMT 0.5% |
| Melting Point | 150°C – 154°C |