U.S. PHARMACOPEIA

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Corticotropin for Injection

Corticotropin.
Corticotropin [9002-60-2].
» Corticotropin for Injection is the sterile, dry material containing the polypeptide hormone having the property of increasing the rate of secretion of adrenal corticosteroids, which is obtained from the anterior lobe of the pituitary of mammals used for food by man. 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 and suitable diluents and buffers.
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1.
Labeling— If the labeling of Corticotropin for Injection recommends intravenous administration, include specific information on dosage.
Bacterial endotoxins 85— It contains not more than 3.1 USP Endotoxin Units per USP Corticotropin Unit.
Vasopressin activity—
Phosphate buffer, Mobile phase, Standard solution, and Chromatographic system— Prepare as directed for Vasopressin activity under Corticotropin Injection.
Test solution— Dissolve the entire contents of a vial of Corticotropin for Injection in a known volume of Phosphate buffer, and dilute with Phosphate buffer to obtain a final solution containing 2.0 USP Corticotropin Units per mL.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the vasopressin activity in USP Vasopressin Unit per USP Corticotropin Unit by the formula:
C(rU / rS)/2,
in which C is the concentration, in USP Vasopressin Units per mL, of the Standard solution; and rU and rS are the peak responses obtained from the Test solution and the Standard solution, respectively. The vasopressin activity is not more than 0.05 USP Vasopressin Unit per USP Corticotropin Unit.
pH 791: between 2.5 and 6.0, in a solution constituted as directed in the labeling supplied by the manufacturer.
Particulate matter 788: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Sterility Tests 71, Uniformity of Dosage Units 905, and Constituted Solutions and Labeling under Injections 1.
Assay— Proceed with the constituted solution of Corticotropin for Injection as directed in the Assay under Corticotropin Injection.
Auxiliary Information— Staff Liaison : Larry N. Callahan, Ph.D., Scientist
Expert Committee : (BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
USP29–NF24 Page 594
Pharmacopeial Forum : Volume No. 28(6) Page 1784
Phone Number : 1-301-816-8385