Hydrocortisone Acetate

Hydrocortisone Acetate

Cat Number
API50033
CAS Number
50-03-3

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CAS Number
50-03-3
EINECS
200-004-4
Storage
Store at room temperature
Synonyms
Cortisol 21-acetate; Hydrocortisone 21-acetate; Cortell; Cortef acetate; Cortisol acetate; Cortifoam; Lanacort; Carmol HC; Dricort; Micort-hc; Hemsol-HC
Molecular Formula
C23H32O6
Molecular Weight
404.5
Smiles
CC(=O)OCC(=O)[C@]1(CC[C@@H]2[C@@]1(C[C@@H]([C@H]3[C@H]2CCC4=CC(=O)CC[C@]34C)O)C)O
Appearance
White to off-white powder
Melting Point
223℃
Boiling Point
446℃
Relative Density
1.4593
General Description
Hydrocortisone acetate is a synthetic glucocorticoid ester of hydrocortisone (cortisol), used primarily for its topical anti-inflammatory and immunosuppressive properties. It is available in a wide range of formulations including creams, ointments, lotions, and suppositories, often at low over-the-counter potencies. The acetate ester improves lipophilicity, enhancing skin penetration and providing a reservoir effect in the stratum corneum.
Mechanism of Action
Following cutaneous absorption, hydrocortisone acetate is hydrolyzed to active hydrocortisone, which binds to cytosolic glucocorticoid receptors. The receptor-ligand complex translocates to the nucleus, modulating transcription of genes involved in inflammation, including suppression of pro-inflammatory cytokines, inhibition of phospholipase A2 via induction of annexin-1, and reduced leukocyte migration. This results in decreased vasodilation, edema, and pruritus at the site of application.
Application
It is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, including atopic dermatitis, contact dermatitis, eczema, and insect bite reactions. Low-potency formulations (0.5% to 1%) are available without prescription for mild conditions, while higher potencies require a prescription. It should not be applied to infected skin, rosacea, or perioral dermatitis. Prolonged use on large surface areas, particularly under occlusion, can cause systemic absorption and adrenal suppression.

Does Hydrocortisone Acetate require protection from light during storage?

Yes, it is moderately photosensitive. Prolonged light exposure can cause discoloration and degradation. Store in light-resistant containers, preferably amber glass.

What is the recommended storage temperature for Hydrocortisone Acetate?

Store at controlled room temperature (15-25°C). Avoid excessive heat above 30°C, as the acetate ester may hydrolyze, especially in the presence of moisture.

Is Hydrocortisone Acetate stable in topical cream and ointment formulations?

Yes, it shows good stability in common topical bases. We provide compatibility data for various emollients, preservatives, and pH ranges.

How is the impurity hydrocortisone (free alcohol) monitored during stability?

This primary hydrolysis product is specifically quantified using a stability-indicating HPLC method, ensuring it remains below pharmacopoeial limits for topical use.
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