A: Using a solution of it in a mixture of methanol and chloroform (4:1)containing about 1mg of cyclosporine per mL(test solution)and a Standard solution containing 1mg of USP Cyclosporine RSin the same solvent mixture,proceed as directed in Identificationtest Aunder Cyclosporine Injection,beginning with “Separately apply 10-µLportions of the test solution”:the Oral Solution meets the requirements of the test.

B: The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.

Add the following:

FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.USP28

Add the following:

FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.USP28

Internal standard solution,Chromatographic system,and System suitability— Proceed as directed in the test for Alcohol contentunder Cyclosporine Injection.

Standard stock solution— Transfer about 2.5g of dehydrated alcohol,accurately weighed,to a 50-mLvolumetric flask,dilute with butyl alcohol to volume,and mix.

Standard preparation— Transfer 5.0mLof Standard stock solutionand 6.0mLof Internal standard solutionto a 25-mLvolumetric flask,dilute with butyl alcohol to volume,and mix.

Test preparation— Transfer an accurately weighed portion of Oral Solution,equivalent to about 250mg of C2H5OH,to a 25-mLvolumetric flask,add 6.0mLof Internal standard solution,dilute with butyl alcohol to volume,and mix.

Procedure— Proceed as directed for Procedurein the test for Alcohol contentunder Cyclosporine Injection.Calculate the quantity,in mg,of C2H5OHin the portion of Oral Solution taken by the formula: in which the terms are as defined therein:between 80.0%and 120.0%of the labeled amount of C2H5OHis found.

Mobile phase— Prepare as directed in the Assayunder Cyclosporine Injection.

Solvent mixture— Prepare a mixture of methanol and chloroform (4:1).

Standard preparation— Dissolve an accurately weighed quantity of USP Cyclosporine RSin Solvent mixtureto obtain a solution having a known concentration of about 1mg per mL.Use this solution promptly after preparation.

Assay preparation— Quantitatively dilute an accurately measured volume of Oral Solution with Solvent mixtureto obtain a solution containing about 1mg of cyclosporine per mL.Use this solution promptly after preparation.

Chromatographic system— Proceed as directed for Chromatographic systemin the Assayunder Cyclosporine Injection,except to maintain the column at 50instead of 70.

Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of cyclosporine (C62H111N11O12)in each mLof the Oral Solution taken by the formula: in which Lis the labeled quantity,in mg,of cyclosporine in each mLof Oral Solution taken;Dis the concentration,in mg per mL,of the Assay preparation,based on the labeled quantity of cyclosporine in the volume of Oral Solution taken and the extent of dilution;Cis the concentration,in mg per mL,of USP Cyclosporine RSin the Standard preparation;Pis the purity,in µg per mg,of USP Cyclosporine RS;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.