Hydrocortisone Sodium Succinate is a water-soluble corticosteroid active pharmaceutical ingredient and the sodium salt of the succinate ester of hydrocortisone. It is developed for pharmaceutical formulations where a rapidly available, water-soluble form of hydrocortisone is required.
Hydrocortisone Sodium Succinate has the molecular formula C25H33NaO8 and a molecular weight of approximately 484.50 g/mol. Its CAS Number is 125-04-2.
Hydrocortisone Sodium Succinate is a synthetic corticosteroid ester derived from hydrocortisone. Conversion of hydrocortisone to the succinate ester and sodium salt substantially improves its water solubility, making it particularly suitable for parenteral pharmaceutical formulations.
After administration, the succinate ester is hydrolyzed to hydrocortisone, which provides glucocorticoid activity.
Hydrocortisone released from Hydrocortisone Sodium Succinate binds to intracellular glucocorticoid receptors. The resulting receptor complex influences gene transcription and modulates inflammatory and immune responses.
Its pharmacological effects include:
Hydrocortisone Sodium Succinate API is used in the development and manufacture of:
Hydrocortisone Sodium Succinate is manufactured through controlled esterification and salt-formation processes followed by purification, drying and pharmaceutical quality testing.
Quality control may include identification, assay, related substances, water content, pH, optical rotation, residual solvents and other applicable pharmaceutical-quality parameters.
Hydrocortisone Sodium Succinate is generally supplied as a white to almost white crystalline powder. Unlike Hydrocortisone Base, the sodium succinate form has substantially improved water solubility and is therefore suitable for preparation of injectable solutions.
Hydrocortisone Sodium Succinate should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should comply with the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the 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% |
| pH (1% Solution) | 7.0 – 8.5 |
| Specific Rotation | +160° to +170° |
| Melting Point | Approximately 220°C (decomposition) |
| Solubility | Freely soluble in water; soluble in alcohol |