(Official January 1, 2007)

Diluent, Mobile phase, System suitability solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Diethylstilbestrol.

Assay preparation— Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 5 mg of diethylstilbestrol, to a 50-mL volumetric flask. Add about 35 mL of Diluent, and sonicate until the powder is dissolved (about 2 hours). Dilute with Diluent to volume, and mix. Allow the mixture to stand until a clear supernatant is obtained. Pipet 10.0 mL of the supernatant into a 50-mL volumetric flask, dilute with Diluent to volume, and mix.

Procedure— Proceed as directed for Procedure in the Assay under Diethylstilbestrol. Calculate the quantity, in mg, of diethylstilbestrol (C18H20O2) in the portion of Tablets taken by the formula: in which the terms are as defined therein.