Medium: water;900mL.

Apparatus 2 :50rpm.

Time: 30minutes.

Procedure— Measure the UVabsorption of filtered aliquots removed from the Dissolution Mediumand suitably diluted,if necessary,in 1-cm cells at 246nm,with a suitable spectrophotometer,using water as the blank and utilizing a standard curve,representing the absorbance versus concentration of USP Methylprednisolone RS.[NOTE—Dissolve about 20mg of USP Methylprednisolone RS,accurately weighed,in 1mLof alcohol,dilute in a 1000-mLvolumetric flask with water to volume,and mix.Prepare quantitative dilutions of this solution for the development of a standard curve.]

Tolerances— Not less than 70%(Q)of the labeled amount of C22H30O5is dissolved in 30minutes.

PROCEDURE FOR CONTENT UNIFORMITY—

Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Methylprednisolone.

Test preparation— Place 1Tablet in a suitable container.For tablet labeled strengths of 10mg or less,add 0.5mLof water.For tablet labeled strengths greater than 10mg,add 1.0mLof water.Allow the tablet to stand for about 2minutes,then swirl the container to disperse the tablet.Add 5.0mLof Internal standard solutionfor each mg of labeled tablet strength,shake for 15minutes,and filter or centrifuge a portion of the test specimen.Analyze the clear solution as directed under Procedure.

Procedure— Proceed as directed for Procedurein the Assayunder Methylprednisolone.Calculate the quantity,in mg,of C22H30O5in the Tablet taken by the formula: in which Fis the ratio of the volume of Internal standard preparation,in mL,in the Test preparationto the volume,in mL,of the Internal standard preparationin the Standard preparation;WSis the weight,in mg,of USP Methylprednisolone RStaken for the Standard preparation;and the other terms are as defined for Procedurein the Assayunder Methylprednisolone.

Mobile phase,Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Methylprednisolone.

Assay preparation— Accurately weigh 20Tablets,and grind to a fine powder in a mortar and pestle.Accurately weigh a portion of the powder,equivalent to about 10mg of methylprednisolone,and transfer to a suitable container.Add 2.5mLof water to the ground tablet material and swirl to form a fine slurry.Add 50.0mLof Internal standard solution,and shake for 15minutes.Filter or centrifuge a portion of the liquid so obtained,if necessary,and analyze the clear solution as directed under Procedure.

Procedure— Proceed as directed for Procedurein the Assayunder Methylprednisolone.Calculate the quantity,in mg,of C22H30O5in the portion of Tablets taken by the formula: in which the terms are as defined therein.