Medium: 0.07MpH7.0phosphate buffer,prepared by dissolving 3.7g of monobasic sodium phosphate and 5.7g of anhydrous dibasic sodium phosphate in 1000mLof water;900mL.

Apparatus 2: 50rpm.

Time: 30minutes.

Procedure— Test 5.0mLof constituted Cefuroxime Axetil for Oral Suspension equivalent to 125or 250mg of cefuroxime (C16H16N4O8S).Determine the amount of cefuroxime equivalent (C16H16N4O8S)dissolved by employing UVabsorption at the wavelength of maximum absorbance at about 280nm on filtered portions of the solution under test,suitably diluted with Dissolution Medium,if necessary,in comparison with a Standard solution having a known concentration of USP Cefuroxime Axetil RSin the same Medium.

Tolerances— Not less than 60%(Q)of the labeled amount of C16H16N4O8Sis dissolved in 30minutes.

FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS— Constitute Cefuroxime Axetil for Oral Suspension as directed in the labeling.Mix,and allow the contents of the container to drain into a beaker for 5seconds.Withdraw and assay 5.0mLof Cefuroxime Axetil for Oral Suspension from the beaker,or the total amount if it is less than 5mL.It meets the requirements.

FOR SOLID PACKAGED IN MULTIPLE-UNIT CONTAINERS— Constitute Cefuroxime Axetil for Oral Suspension as directed in the labeling.It meets the requirements.

0.2M Monobasic ammonium phosphate,Mobile phase,and Chromatographic system— Proceed as directed in theAssayunder Cefuroxime Axetil.

Resolution solution— In a 50-mLvolumetric flask,mix 10.0mLof a solution of USP Cefuroxime Axetil RSin methanol containing 1.2mg per mL,5.0mLof methanol,and 3.8mLof a solution of USP Cefuroxime Axetil Delta-3Isomers RSin methanol containing 0.16mg per mL.Dilute with 0.2M Monobasic ammonium phosphateto volume,and mix.

Standard preparation— Transfer about 30mg of USP Cefuroxime Axetil RS,accurately weighed,to a 25-mLvolumetric flask,dissolve in and dilute with methanol to volume,and mix.Promptly transfer 10.0mLof this solution to a 50-mLvolumetric flask,add 8.8mLof methanol,dilute with 0.2M Monobasic ammonium phosphateto volume,and mix.

Assay preparation— Transfer to a 100-mLvolumetric flask an accurately measured portion of Cefuroxime Axetil for Oral Suspension,freshly mixed and free from air bubbles,constituted as directed in the labeling,and equivalent to about 250mg of cefuroxime.Add about 50mLof methanol,and shake by mechanical means for about 10minutes.Dilute with methanol to volume,and mix.Filter a portion of this stock solution,and transfer 5.0mLof the filtrate to a 50-mLvolumetric flask.Add 13.8mLof methanol,dilute with 0.2M Monobasic ammonium phosphateto volume,and mix.[NOTE—Protect this Assay preparationfrom light and use promptly,or refrigerate and use on the day prepared.]

Procedure— Proceed as directed in theAssayunderCefuroxime Axetil.Calculate the quantity,in mg,of cefuroxime (C16H16N4O8S)in each mLof Cefuroxime Axetil for Oral Suspension taken by the formula: in which Vis the volume,in mL,of Cefuroxime Axetil for Oral Suspension taken to prepare the Assay preparation;rUand rSare the sums of the peak responses of the cefuroxime axetil diastereoisomers Aand Bobtained from the Assay preparationand the Standard preparation,respectively;and the other terms are as defined therein.