Medium: 0.5%sodium lauryl sulfate;900mL.

Apparatus 2: 50rpm.

Time: 45minutes.

Sodium lauryl sulfate stock solution— Transfer 180.0g of sodium lauryl sulfate to a 2000-mLvolumetric flask.Add 1500mLof water,and stir until dissolved.[NOTE—Several hours of stirring are required.]Dilute with water to volume.

Standard stock solution— Dissolve about 70mg of USP Medroxyprogesterone Acetate RS,accurately weighed,in 140mLof Sodium lauryl sulfate stock solution,and dilute with water to 250mL.[NOTE—It may be necessary to sonicate the solution to bring the Reference Standard into solution prior to dilution with water.Prepare this Standard stock solutionfresh daily.]

Standard solution— Pipet a 20-mLaliquot of Standard stock solutioninto a 1Lvolumetric flask.Add 40mLof Sodium lauryl sulfate stock solution,and dilute with water to volume.This solution is stable for up to 7days.

Test solution— Withdraw 15mLof the solution under test,and filter,discarding the first 5mLof the filtrate.

Mobile phase— Prepare a filtered and degassed solution of acetonitrile and water (60:40).Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).

Chromatographic system (see Chromatography á621ñ)— The liquid chromatograph is equipped with a 254-nm detector and a 4-mm ×8-cm column that contains packing L7.The flow rate is about 1.5mLper minute.Chromatograph the Standard solution,and record the peak responses as directed for Procedure:the tailing factor for the analyte peak is not more than 1.2;and the relative standard deviation for replicate injections is not more than 2.0%.

Procedure— Separately inject equal volumes (about 20µL)of the Standard solutionand the Test solutioninto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the percentage of C24H34O4dissolved from the peak responses so obtained.

Tolerances— Not less than 50%(Q)of the labeled amount of C24H34O4is dissolved in 45minutes.

Procedure for content uniformity— Dissolve an accurately weighed portion of USP Medroxyprogesterone Acetate RSin a mixture of alcohol and water (3:1)to obtain a solution having a known concentration of about 15µg per mL.Transfer 1Tablet to a volumetric flask,add a mixture of alcohol and water (3:1)to volume,and shake for about 15minutes.Filter,and quantitatively dilute a portion of the filtrate as required to obtain a final solution containing about 15µg per mL.Concomitantly determine the absorbances of this solution and the Standard solution in 1-cm cells at the wavelength of maximum absorbance at about 242nm.Calculate the quantity,in mg,of C24H34O4in the Tablet taken by the formula: in which Tis the labeled quantity,in mg,of medroxyprogesterone acetate in the Tablet;Dis the concentration,in µg per mL,of medroxyprogesterone acetate in the solution from the Tablet;Cis the concentration,in µg per mL;of USP Medroxyprogesterone Acetate RSin the Standard solution,and AUand ASare the absorbances of the solution from the Tablet and the Standard solution,respectively.

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

Assay preparation— Weigh and finely powder not fewer than 20Tablets.Weigh accurately a portion of the powder,equivalent to about 25mg of medroxyprogesterone acetate,into a 50-mLglass centrifuge tube.Pipet 25mLof acetonitrile into the tube,shake to wet the powder thoroughly,and sonicate for not less than 10minutes,and centrifuge.Use the clear supernatant as the Assay preparation.

Procedure— Proceed as directed for Procedurein the Assayunder Medroxyprogesterone Acetate.Calculate the quantity,in mg,of medroxyprogesterone acetate (C24H34O4)in the portion of Tablets taken by the formula: in which Cis the concentration,in mg per mL,of USP Medroxyprogesterone Acetate RSin the Standard preparation;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.