Methyltestosterone Tablets, chemical structure, molecular formula, Reference Standards

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.

USP Reference standards á11ñ— USP Methyltestosterone RS.

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