Testosterone Propionate Injection
» Testosterone Propionate Injection is a sterile solution of Testosterone Propionate in a suitable vegetable oil. It contains not less than 88.0 percent and not more than 112.0 percent of the labeled amount of C22H32O3.
Packaging and storage Preserve in single-dose or multiple-dose containers, preferably of Type I glass.
Identification Dilute a suitable volume of Injection with chloroform to obtain a solution having a concentration of about 400 µg of testosterone propionate per mL. Proceed as directed in the Identification test under Testosterone Cypionate Injection, beginning with Prepare a 20- × 20-cm thin-layer chromatographic plate, except to use USP Testosterone Propionate RS. The RF value 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 1.
Chromatographic solvent and Isoniazid reagentPrepare as directed in the Assay under Testosterone Enanthate Injection.
Standard preparation Prepare as directed in the Assay under Testosterone Enanthate Injection, using USP Testosterone Propionate RS.
Assay preparation Transfer to a 10-mL volumetric flask an accurately measured volume of Injection, equivalent to about 100 mg of testosterone propionate, add chromatographic n-heptane to volume, and mix. Pipet 5 mL of this solution into a 100-mL volumetric flask, add chromatographic n-heptane to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Testosterone Enanthate Injection. Calculate the quantity, in mg, of C22H32O3 in each mL of the Injection taken by the formula:
2.5(C / V)(AU / AS)in which C is the concentration, in µg per mL, of USP Testosterone Propionate RS in the Standard preparation, V is the volume, in mL, of Injection taken, and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
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USP32NF27 Page 3687