Gonadorelin for Injection
»Gonadorelin for Injection is a sterile mixture of Gonadorelin Hydrochloride with suitable diluents.It contains the equivalent of not less than 90.0percent and not more than 115.0percent of the labeled amount of gonadorelin (C55H75N17O13).
Packaging and storage— Preserve in tight,well-sealed containers.
Identification— The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 3.60USP Endotoxin Units per µg.
pHá791ñ: between 4.0and 8.0,in a solution constituted as directed in the labeling.
Other requirements— It meets the requirements for Sterility Tests á71ñand for Labelingunder Injections á1ñ.
Assay—
Buffer solution,Mobile phase,Standard preparations,Chromatographic system,and Identification solution— Proceed as directed in the Assayunder Gonadorelin Hydrochloride.
Assay preparation— Separately dissolve the contents of not less than 5vials of Gonadorelin for Injection in Mobile phaseto obtain a concentration of 100µg of gonadorelin per mL.Place the vials in an ultrasonic bath for 5minutes,and allow to cool at room temperature.Combine the solutions in the vials to obtain the Assay preparation.
Procedure— Proceed as directed in the Assayunder Gonadorelin Hydrochloride.Plot the responses of the gonadorelin peaks versus concentration,in mg per mL,of gonadorelin in each of the Standard preparation.Calculate the quantity of gonadorelin (C55H75N17O13)in the Gonadorelin for Injection taken for the Assay preparationby the formula:
(1182.33/1255.4)(C)(V+0.06),
in which 1182.33and 1255.4are the molecular weights of gonadorelin and gonadorelin hydrochloride,respectively;Cis the concentration of gonadorelin in the Assay preparationas obtained from the regression line;Vis the volume,in mL,of Mobile phaseused to prepare the Assay preparation;and 0.06is the correction factor for the volume created by the dissolved test specimen.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(BNT)Biotechnology and Natural Therapeutics/Diagnostics
USP28–NF23Page 917
Phone Number:1-301-816-8178