Testosterone Propionate Injection
»Testosterone Propionate Injection is a sterile solution of Testosterone Propionate in a suitable vegetable oil.It contains not less than 88.0percent and not more than 112.0percent of the labeled amount of C22H32O3.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass.
Identification— Dilute a suitable volume of Injection with chloroform to obtain a solution having a concentration of about 400µg of testosterone propionate per mL.Proceed as directed in the Identificationtest under Testosterone Cypionate Injection,beginning with “Prepare a 20-×20-cm thin-layer chromatographic plate,”except to use USP Testosterone Propionate RS.The RFvalue of the principal spot obtained from the solution under test corresponds to that obtained from the Standard solution.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Chromatographic solvent and Isoniazid reagent—Prepare as directed in the Assayunder Testosterone Enanthate Injection.
Standard preparation— Prepare as directed in the Assayunder Testosterone Enanthate Injection,using USP Testosterone Propionate RS.
Assay preparation— Transfer to a 10-mLvolumetric flask an accurately measured volume of Injection,equivalent to about 100mg of testosterone propionate,add chromatographic n-heptane to volume,and mix.Pipet 5mLof this solution into a 100-mLvolumetric flask,add chromatographic n-heptane to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Testosterone Enanthate Injection.Calculate the quantity,in mg,of C22H32O3in each mLof the Injection taken by the formula:
2.5(C/V)(AU/AS),
in which Cis the concentration,in µg per mL,of USP Testosterone Propionate RSin the Standard preparation,Vis the volume,in mL,of Injection taken,and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1878
Phone Number:1-301-816-8139
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