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.
Assay—
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 C
22H
32O
3 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.
467
:
meets the requirements.