Corticotropin Zinc Hydroxide is a prolonged-acting preparation of corticotropin (adrenocorticotropic hormone, ACTH) associated with zinc hydroxide. Corticotropin is a peptide hormone that stimulates the adrenal cortex to produce and release corticosteroid hormones, particularly glucocorticoids.
Corticotropin Zinc Hydroxide is a biological peptide preparation containing corticotropin associated with zinc hydroxide to provide a prolonged-release pharmaceutical formulation. Corticotropin is derived from or chemically represented by the amino-acid sequence corresponding to human ACTH.
The active corticotropin peptide consists of 39 amino acids and has a molecular weight of approximately 4.54 kDa. Its biological activity is related primarily to stimulation of melanocortin 2 receptors (MC2R) in the adrenal cortex.
Corticotropin stimulates adrenal cortical cells through the melanocortin 2 receptor (MC2R). Activation of this receptor promotes steroidogenesis and increases production of adrenal corticosteroid hormones.
Corticotropin preparations have been used therapeutically in conditions where stimulation of endogenous adrenal corticosteroid production is clinically appropriate. Applications and approved indications depend on the specific pharmaceutical formulation and applicable regulatory jurisdiction.
The zinc hydroxide component is associated with the corticotropin peptide to provide a longer-acting depot preparation compared with rapidly absorbed corticotropin preparations.
As a peptide/biological pharmaceutical substance, quality evaluation may include identity, peptide content, biological potency, purity, related peptides, residual solvents/reagents, microbial quality and other applicable critical quality attributes.
Final specifications should be established according to the applicable approved product specification, validated analytical methods and batch-specific Certificate of Analysis (CoA).
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | Conforms to Corticotropin identity by validated peptide analytical methods |
| Assay (HPLC) | NLT 95.0% peptide content by validated HPLC method |
| Loss on Drying | NMT 5.0% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Water Content | NMT 5.0% |
| Melting Point | 150°C – 154°C |