Hydrocortisone Hemisuccinate is a water-soluble ester of hydrocortisone belonging to the glucocorticoid class of corticosteroids. It is designed to provide corticosteroid activity in pharmaceutical formulations where enhanced aqueous solubility compared with hydrocortisone itself is advantageous.
The compound is commonly encountered in pharmaceutical products as hydrocortisone sodium succinate, a water-soluble salt used particularly for parenteral administration.
Hydrocortisone Hemisuccinate is a specialized steroid pharmaceutical API requiring controlled synthesis, purification and analytical characterization. Manufacturing quality control focuses on steroid identity, assay, related substances, degradation products, water content and residual impurities.
For injectable applications, additional controls such as bacterial endotoxins, sterility and particulate matter apply to the finished pharmaceutical product.
CAS Number: 2203-97-6
Molecular Formula: C25H34O8
Molecular Weight: 462.54 g/mol
Common Salt Form: Hydrocortisone Sodium Succinate
Drug Class: Corticosteroid
Pharmacological Class: Glucocorticoid
Therapeutic Class: Anti-inflammatory / Immunosuppressant
Therapeutic Area: Endocrinology / Allergy / Inflammation
Hydrocortisone Hemisuccinate provides the pharmacological activity of hydrocortisone. The active corticosteroid binds to intracellular glucocorticoid receptors, and the resulting receptor complex regulates gene transcription.
This suppresses multiple inflammatory pathways and reduces the production and activity of inflammatory mediators, resulting in anti-inflammatory and immunosuppressive effects.
Hydrocortisone Hemisuccinate, particularly its sodium salt, is used in pharmaceutical formulations for conditions requiring systemic corticosteroid therapy, including:
Specific applications depend on the approved formulation and regulatory labeling.
Hydrocortisone sodium succinate is particularly suitable for parenteral formulations because the salt is highly water soluble. This permits preparation of injectable solutions for situations where rapid systemic corticosteroid therapy is required.
Hydrocortisone Hemisuccinate is a synthetic steroid ester containing the characteristic corticosteroid nucleus together with a hemisuccinate ester group.
The free acid is considerably less water soluble than its sodium salt. Pharmaceutical-grade hydrocortisone sodium succinate is generally supplied as a white or almost white powder and is readily soluble in water.
Hydrocortisone Hemisuccinate API quality evaluation may include:
Hydrocortisone Hemisuccinate should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage conditions should follow validated stability data and the applicable product-specific specification.
Hydrocortisone Hemisuccinate is relevant to pharmaceutical development involving glucocorticoid therapy, corticosteroid receptor activity, systemic inflammation and water-soluble injectable corticosteroid formulations.
Hydrocortisone Hemisuccinate is a water-soluble corticosteroid ester of hydrocortisone with CAS Number 2203-97-6, molecular formula C25H34O8, and molecular weight 462.54 g/mol. Its sodium salt, hydrocortisone sodium succinate, is an important pharmaceutical form used for systemic corticosteroid therapy, particularly in injectable preparations.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 103.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| Water Content | NMT 5.0% |