Methyltestosterone Tablets
»Methyltestosterone Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of methyltestosterone (C20H30O2).
Packaging and storage— Preserve in well-closed containers.
Identification— Evaporate to dryness 25mLof the first alcohol solution of methyltestosterone obtained in the Assay:the IRabsorption spectrum of a potassium bromide dispersion of the residue so obtained exhibits maxima at the same wavelengths as that of a similar preparation of USP Methyltestosterone RS.
Disintegration á701ñ: 30minutes.Tablets intended for buccal administration meet the requirements for Buccal Tablets.
Uniformity of dosage units á905ñ: meet the requirements.
Procedure for content uniformity— Transfer 1finely powdered Tablet to a 100-mLvolumetric flask,add 50mLof methanol,and shake by mechanical means for 60minutes.Dilute with methanol to volume,and filter,discarding the first 20mLof the filtrate.Dilute a portion of the subsequent filtrate quantitatively and stepwise,if necessary,with methanol to provide a solution containing about 10µg of methyltestosterone per mL.Concomitantly determine the absorbances of this solution and a solution of USP Methyltestosterone RSin the same medium having a known concentration of about 10µg per mL,in 1-cm cells at the wavelength of maximum absorbance at about 241nm,with a suitable spectrophotometer,using methanol as the blank.Calculate the quantity,in mg,of C20H30O2in the Tablet taken by the formula:
(T/D)C(AU/AS),
in which Tis the labeled quantity,in mg,of methyltestosterone in the Tablet;Dis 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;Cis the concentration,in µg per mL,of USP Methyltestosterone RSin the Standard solution;and AUand ASare the absorbances of the solution from the Tablet and the Standard solution,respectively.
Assay— Weigh and finely powder not less than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 10mg of methyltestosterone,and transfer to a 125-mLseparator with the aid of about 5mLof water.Extract with four 25-mLportions of chloroform,filtering each through chloroform-washed cotton.Evaporate the combined extracts on a steam bath,with the aid of a current of air,to dryness.Dissolve the residue in alcohol,transfer to a 50-mLvolumetric flask,add alcohol to volume,and mix.Pipet a 5-mLaliquot into a 100-mLvolumetric flask,add alcohol to volume,and mix.Concomitantly determine the absorbances of this solution and a solution of USP Methyltestosterone RSin the same medium having a known concentration of about 10µg per mL,in 1-cm cells at the wavelength of maximum absorbance at about 241nm,with a suitable spectrophotometer,using alcohol as the blank.Calculate the quantity,in mg,of methyltestosterone (C20H30O2)in the portion of Tablets taken by the formula:
C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Methyltestosterone RSin the Standard solution;and AUand ASare the absorbances of the solution from the Tablets and the Standard solution,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1274
Phone Number:1-301-816-8139
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