USP Monographs: Repository Corticotropin Injection

Repository Corticotropin Injection

Corticotropin.
Corticotropin

[9002-60-2].

» Repository Corticotropin Injection is corticotropin in a solution of partially hydrolyzed gelatin. Its potency is not less than 80.0 percent and not more than 125.0 percent of the potency stated on the label in USP Corticotropin Units. It may contain a suitable antimicrobial agent.

Packaging and storage— Preserve in single-dose or multiple-dose containers, preferably of Type I glass.

USP Reference standards

— USP Ascorbic Acid RS. USP Corticotropin RS. USP Endotoxin RS. USP Posterior Pituitary RS.

Bacterial endotoxins

— It contains not more than 3.1 USP Endotoxin Units per USP Corticotropin Unit.

Vasopressin activity, pH, and Assay— It meets the requirements for Vasopressin activity, pH, and Assay under Corticotropin Injection.

Other requirements— It meets the requirements under Injections

Auxiliary Information— Staff Liaison : Larry N. Callahan, Ph.D., Scientist

Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides

USP29–NF24 Page 594

Phone Number : 1-301-816-8385


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