» Diethylstilbestrol Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C18H20O2.
Packaging and storage Preserve in well-closed containers.
USP Reference standards 11
Identification The Tablets respond to Identification test B under Diethylstilbestrol.
Disintegration 701: 30 minutes.
Uniformity of dosage units 905: meet the requirements.
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:
250C(rt, U + 1.26rc, U) / (rt, S + 1.26rc, S)in which the terms are as defined therein.
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USP35NF30 Page 2896