Procedure for content uniformity—
Transfer 1 finely powdered Tablet to a 100-mL volumetric flask, add 50 mL of methanol, and shake by mechanical means for 60 minutes. Dilute with methanol to volume, and filter, discarding the first 20 mL of the filtrate. Dilute a portion of the subsequent filtrate quantitatively and stepwise, if necessary, with methanol to provide a solution containing about 10 µg of methyltestosterone per mL. Concomitantly determine the absorbances of this solution and a solution of
USP Methyltestosterone RS in the same medium having a known concentration of about 10 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 241 nm, with a suitable spectrophotometer, using methanol as the blank. Calculate the quantity, in mg, of C
20H
30O
2 in the Tablet taken by the formula:
(T / D)C(AU / AS),
in which
T is the labeled quantity, in mg, of methyltestosterone in the Tablet;
D is the concentration, in µg per mL, of methyltestosterone in the solution from the Tablet, based on the labeled quantity per Tablet and the extent of dilution;
C is the concentration, in µg per mL, of
USP Methyltestosterone RS in the Standard solution; and
AU and
AS are the absorbances of the solution from the Tablet and the Standard solution, respectively.
701
:
30 minutes. Tablets intended for buccal administration meet the requirements for Buccal Tablets.