Diflorasone Diacetate is a synthetic topical corticosteroid and pharmaceutical active ingredient used for the treatment of inflammatory and corticosteroid-responsive skin conditions. It belongs to the glucocorticoid class and provides anti-inflammatory, antipruritic and vasoconstrictive effects when applied topically.
Diflorasone Diacetate is a fluorinated corticosteroid ester developed for topical dermatological formulations. Its corticosteroid activity helps reduce inflammation, itching and other symptoms associated with steroid-responsive dermatoses.
Diflorasone Diacetate is identified by CAS No. 33564-31-7. Its molecular formula is C26H32F2O7 and its molecular weight is approximately 494.53 g/mol.
Diflorasone Diacetate acts as a potent topical glucocorticoid. It interacts with intracellular glucocorticoid receptors, resulting in regulation of gene expression and suppression of inflammatory processes in the skin.
After penetrating the skin, Diflorasone Diacetate interacts with glucocorticoid receptors within cells. The resulting receptor complex influences transcription of corticosteroid-responsive genes and reduces the production and activity of inflammatory mediators.
This results in decreased inflammation, erythema, swelling and itching associated with corticosteroid-responsive dermatoses.
Diflorasone Diacetate is used in topical pharmaceutical preparations for corticosteroid-responsive skin disorders, including:
Specific indications and approved formulations vary according to the country and regulatory authority.
Diflorasone Diacetate is relevant to pharmaceutical manufacturers and formulation-development organizations working on topical corticosteroid creams, ointments and other dermatological preparations.
The API may be incorporated into topical formulations according to the approved formulation, concentration, intended route and applicable regulatory requirements.
Diflorasone Diacetate API quality evaluation may include:
Testing should be performed using validated analytical methods appropriate for the API and intended formulation.
Diflorasone Diacetate 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.
Diflorasone Diacetate 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.
Diflorasone Diacetate is relevant to pharmaceutical companies developing and manufacturing topical dermatological corticosteroid formulations.
For commercial applications, customers should verify the API grade, identity, assay, purity, impurity profile, specification, regulatory documentation and batch-specific CoA before use.
Consistent Diflorasone Diacetate API quality is important for reliable topical 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 |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
| Melting Point | 150°C – 154°C |