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 80.0percent and not more than 125.0percent 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 Solidsas described under Injections á1ñ.
Labeling— If the labeling of Corticotropin for Injection recommends intravenous administration,include specific information on dosage.
Bacterial endotoxins á85ñ— It contains not more than 3.1USP 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 2.0USP Corticotropin Units per mL.
Procedure— Separately inject equal volumes (about 20µL)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 Cis the concentration,in USP Vasopressin Units per mL,of the Standard solution;and rUand rSare the peak responses obtained from the Test solution and the Standard solution,respectively.The vasopressin activity is not more than 0.05USP Vasopressin Unit per USP Corticotropin Unit.
pHá791ñ: between 2.5and 6.0,in a solution constituted as directed in the labeling supplied by the manufacturer.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements for Sterility Tests á71ñ,Uniformity of Dosage Units á905ñ,and Constituted Solutionsand Labelingunder Injections á1ñ.
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:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 545
Pharmacopeial Forum:Volume No.28(6)Page 1784
Phone Number:1-301-816-8385