Hydrocortisone Base is a naturally occurring glucocorticoid active pharmaceutical ingredient with anti-inflammatory and immunosuppressive properties. It is the non-salt, free-base form of hydrocortisone and is widely used in the development and manufacture of corticosteroid pharmaceutical formulations.
Hydrocortisone has the molecular formula C21H30O5 and a molecular weight of 362.46 g/mol. Its CAS Number is 50-23-7.
Hydrocortisone, also known as cortisol, is a corticosteroid hormone produced naturally by the adrenal cortex. Pharmaceutical hydrocortisone is used to provide glucocorticoid activity and is incorporated into various topical, oral and parenteral formulations.
Hydrocortisone Base is chemically a steroid containing hydroxyl, ketone and side-chain functional groups characteristic of glucocorticoids.
Hydrocortisone acts primarily through the glucocorticoid receptor. After entering cells, it binds to intracellular glucocorticoid receptors and influences gene transcription.
This results in modulation of inflammatory and immune responses, including reduction of inflammatory mediator production and suppression of excessive immune activity.
Hydrocortisone Base API is used in the development and manufacture of:
Hydrocortisone is a steroidal pharmaceutical compound produced through controlled manufacturing processes followed by purification, crystallization and drying.
Quality control may include identity, assay, related substances, water content, residue on ignition, optical rotation and other applicable pharmaceutical-quality parameters.
Hydrocortisone Base is generally described as a white or almost white crystalline powder. It is practically insoluble in water and soluble in certain organic solvents.
The free base should be distinguished from hydrocortisone sodium succinate, hydrocortisone sodium phosphate and other hydrocortisone derivatives because their molecular formulas, molecular weights and specifications are different.
Hydrocortisone Base should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0% – 103.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Specific Rotation | +160° to +166° |
| Melting Point | Approximately 215–220°C (decomposition) |
| Solubility | Practically insoluble in water; soluble in acetone and slightly soluble in alcohol |