Gonadorelin for Injection
» Gonadorelin for Injection is a sterile mixture of Gonadorelin Hydrochloride with suitable diluents. It contains the equivalent of not less than 90.0 percent and not more than 115.0 percent 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 preparation corresponds 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 Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 3.60 USP Endotoxin Units per µg.
pH 791: between 4.0 and 8.0, in a solution constituted as directed in the labeling.
Other requirements— It meets the requirements for Sterility Tests 71 and for Labeling under Injections 1.
Assay—
Buffer solution, Mobile phase, Standard preparations, Chromatographic system, and Identification solution Proceed as directed in the Assay under Gonadorelin Hydrochloride.
Assay preparation— Separately dissolve the contents of not less than 5 vials of Gonadorelin for Injection in Mobile phase to obtain a concentration of 100 µg of gonadorelin per mL. Place the vials in an ultrasonic bath for 5 minutes, and allow to cool at room temperature. Combine the solutions in the vials to obtain the Assay preparation.
Procedure— Proceed as directed in the Assay under 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 preparation by the formula:
(1182.33 / 1255.4)(C)(V + 0.06)
in which 1182.33 and 1255.4 are the molecular weights of gonadorelin and gonadorelin hydrochloride, respectively; C is the concentration of gonadorelin in the Assay preparation as obtained from the regression line; V is the volume, in mL, of Mobile phase used to prepare the Assay preparation; and 0.06 is the correction factor for the volume created by the dissolved test specimen.
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Topic/Question Contact Expert Committee
Monograph Larry N. Callahan, Ph.D.
Senior Scientist
1-301-816-8385
(BBPP05) Biologics and Biotechnology - Proteins and Polysaccharides
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2522