Hydrocortisone Acetate is the acetate ester of hydrocortisone, a synthetic glucocorticoid with anti-inflammatory and immunosuppressive properties. It is used in a range of pharmaceutical formulations for the management of inflammatory, allergic and corticosteroid-responsive conditions.
Hydrocortisone Acetate is particularly useful in topical, rectal and other localized formulations, where corticosteroid activity is required to reduce inflammation, itching, redness and swelling.
Hydrocortisone Acetate is a well-established corticosteroid pharmaceutical API requiring controlled steroid synthesis, purification and comprehensive analytical testing. Manufacturing quality focuses on chemical identity, assay, related substances, stereochemical purity and control of residual impurities.
CAS Number: 50-03-3
Molecular Formula: C23H32O6
Molecular Weight: 404.50 g/mol
Chemical Name: Hydrocortisone 21-acetate
Drug Class: Corticosteroid
Pharmacological Class: Glucocorticoid
Therapeutic Class: Anti-inflammatory / Immunosuppressant
Therapeutic Area: Dermatology / Endocrinology / Gastroenterology
Hydrocortisone Acetate is converted to active corticosteroid forms in tissues and binds to intracellular glucocorticoid receptors. The receptor complex influences gene transcription and regulates the production of inflammatory mediators.
This produces anti-inflammatory effects including reduction of cytokine activity, inflammatory cell migration, edema and tissue inflammation.
Hydrocortisone Acetate is used in formulations for corticosteroid-responsive conditions such as:
Specific uses depend on the finished dosage form and regulatory labeling.
In topical formulations, Hydrocortisone Acetate helps reduce itching, redness, swelling and inflammation associated with corticosteroid-responsive dermatological conditions.
Its ester form can provide suitable physicochemical characteristics for incorporation into topical preparations.
Hydrocortisone Acetate is a synthetic steroid ester generally obtained as a white or almost white crystalline powder. It is practically insoluble in water and soluble in selected organic solvents.
The compound contains the characteristic corticosteroid steroid nucleus together with an acetate ester at the 21-position.
Hydrocortisone Acetate API quality evaluation may include:
Hydrocortisone Acetate should be stored in a tightly closed container, protected from excessive heat, moisture and direct light. Exact storage conditions should follow validated stability data and the applicable product-specific specification.
Hydrocortisone Acetate remains an established corticosteroid ingredient in pharmaceutical development involving glucocorticoid receptor activity, inflammatory disorders and localized corticosteroid therapy.
Hydrocortisone Acetate is a synthetic glucocorticoid corticosteroid with CAS Number 50-03-3, molecular formula C23H32O6, and molecular weight 404.50 g/mol. It is used in topical, rectal and other pharmaceutical formulations for corticosteroid-responsive inflammatory conditions.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms by IR and HPLC |
| Assay (HPLC) | 97.0% – 103.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |
| Melting Point | Approximately 220–224°C |