Cortisol is a naturally occurring glucocorticoid hormone produced by the adrenal cortex. It plays an important role in regulating metabolism, immune response, stress response and maintenance of physiological functions. Cortisol is also known as hydrocortisone.
Cortisol is a steroid hormone belonging to the glucocorticoid class. It is used as an active pharmaceutical ingredient in the development and manufacture of corticosteroid pharmaceutical products.
Cortisol is identified by CAS No. 50-23-7. Its molecular formula is C₂₁H₃₀O₅, with a molecular weight of 362.46 g/mol.
Cortisol and its pharmaceutical derivatives exert their effects primarily through the glucocorticoid receptor. Following receptor binding, the receptor-ligand complex influences gene transcription and regulates processes involved in inflammation, immune response, carbohydrate metabolism and protein metabolism.
Cortisol is used as a pharmaceutical ingredient in products designed to provide glucocorticoid replacement or corticosteroid activity. Hydrocortisone formulations are used in appropriate clinical applications involving adrenal insufficiency and inflammatory or immune-mediated conditions.
Cortisol API can be supplied for pharmaceutical development, formulation and manufacturing applications, subject to applicable quality and regulatory requirements. Product documentation and batch-specific analytical information can be provided according to the applicable specification.
Quality evaluation may include identity, assay, related substances, loss on drying, residue on ignition, water content, optical rotation and other applicable pharmaceutical quality attributes.
Final acceptance criteria should be based on the approved product specification, validated analytical methods and applicable pharmacopoeial requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–103.0% on the dried basis |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Melting Point | 220–224°C |