Tetracosactide Bioidentity Testing

Tetracosactide is a synthetic form of human adrenocorticotropic hormone (ACTH) which is also known as corticotropin or adrenocorticotropin. The amino acid sequence of Tetracosactide is the same as the first 24 residues of ACTH. Endogenous ACTH is secreted by the anterior pituitary gland which causes the production and release of cortisol by the cortex of the adrenal gland which has both metabolic and immune response functions. ACTH and Tetracosactide also induce the production of corticosterone which is another glucoocorticoid hormone producted in the adrenal cortex. Tetracosactide is used to treat epileptic spasms in infants, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis, lupus, sarcoidosis, various eye conditions as well as several other afflictions.

PBL performing the bioidentity assay for tetracosactide following a procedure outlined in the European Pharmacopeia. A primary cell culture is created from the adrenal glands of rats. The cells are incubated with the dilutions of the tetracosactide reference standard and the drug product. Analysis of corticosterone concentrations is obtained using a fluorometric method and the activity of the drug can be compared to the reference standard.

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