Diethylstilbestrol Tablets
»Diethylstilbestrol Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C18H20O2.
Packaging and storage— Preserve in well-closed containers.
Identification— The Tablets respond to Identificationtest Bunder Diethylstilbestrol.
Uniformity of dosage units á905ñ: meet the requirements.
Assay—
Diluent,Mobile phase,System suitability solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Diethylstilbestrol.
Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 5mg of diethylstilbestrol,to a 50-mLvolumetric flask.Add about 35mLof Diluent,and sonicate until the powder is dissolved (about 2hours).Dilute with Diluentto volume,and mix.Allow the mixture to stand until a clear supernatant is obtained.Pipet 10.0mLof the supernatant into a 50-mLvolumetric flask,dilute with Diluentto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder 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.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 636
Phone Number:1-301-816-8139
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