Test specimen— Transfer 500mg of finely powdered Tablets to a suitable container,add 25mLof acetone,mix,and filter.Evaporate the filtrate at room temperature to dryness,and dry the residue in vacuum over silica gel for 2hours.

Medium: dilute hydrochloric acid (7in 1000);1000mL.

Apparatus 1: 100rpm.

Time: 30minutes.

Procedure— Determine the amount of C13H16N2O2dissolved from UVabsorbances at the wavelength of maximum absorbance at about 237nm on filtered portions of the solution under test,suitably diluted with pH7.5phosphate buffer,in comparison with a Standard solution having a known concentration of USP Aminoglutethimide RSin the same Medium.

Tolerances— Not less than 70%(Q)of the labeled amount of C13H16N2O2is dissolved in 30minutes.

Acetate buffer,Mobile phase,Diluent,and Chromatographic system— Prepare as directed in the Assayunder Aminoglutethimide.

m-Aminoglutethimide solution— Prepare as directed for the Standard solutionin the test for Chromatographic purity and limit of m-aminoglutethimideunder Aminoglutethimide.

Test solution— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 200mg of aminoglutethimide,to a 200-mLvolumetric flask.Add about 130mLof Diluent,and sonicate for 5minutes.Shake by mechanical means for 30minutes,dilute with Diluentto volume,mix,and pass through a 0.45-µm or finer porosity filter,discarding the first 5mLof the filtrate.

Procedure— Separately inject about 10µLof the m-Aminoglutethimide solutionand the Test solutioninto the chromatograph,record the chromatograms,and measure the areas for all of the peaks in the chromatogram obtained from the Test solution.The relative retention times are about 0.8for aminoglutethimide and 1.0for m-aminoglutethimide.Calculate the percentage of each peak,other than the main peak and the m-aminoglutethimide peak,if present,by the same formula: in which riis the response of each peak and rsis the sum of the responses of all of the peaks excluding that of the m-aminoglutethimide peak in the chromatogram obtained from the Test solution:not more than 2.0%total impurities,other than m-aminoglutethimide,is found.

Acetate buffer,Mobile phase,Diluent,Standard preparation,and Chromatographic system— Prepare as directed in the Assayunder Aminoglutethimide.

Assay preparation— Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 200mg of aminoglutethimide,to a 200-mLvolumetric flask.Add about 130mLof Diluent,and sonicate for 5minutes.Shake by mechanical means for 30minutes,dilute with Diluentto volume,and mix.Centrifuge this solution,and transfer 25.0mLof the clear supernatant to a 50-mLvolumetric flask,dilute with Diluentto volume,mix,and pass through a 0.45-µm or finer porosity filter,discarding the first 5mLof the filtrate.

Procedure— Proceed as directed for Procedurein the Assayunder Aminoglutethimide.Calculate the quantity,in mg,of aminoglutethimide (C13H16N2O2)in the portion of Tablets taken by the formula: in which the terms are as defined therein.