A: Place a portion of Oral Suspension,equivalent to about 50mg of diazoxide,in a 50-mLvolumetric flask,add 30mLof 0.1Nsodium hydroxide,shake for 30minutes,dilute with 0.1Nsodium hydroxide to volume,and mix:the solution so obtained responds to the Thin-Layer Chromatographic Identification Test á201ñ,a solvent system consisting of a mixture of ethyl acetate,methanol,and ammonium hydroxide (17:4:3)being used.

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

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

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

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

Assay preparation— Transfer an accurately measured volume of freshly mixed Oral Suspension,equivalent to about 100mg of diazoxide,to a 50-mLcentrifuge tube,add 2mLof water and 35mLof methanol,shake for 15minutes,and centrifuge for 5minutes.Transfer the supernatant to a 200-mLvolumetric flask.Repeat the extraction process two times,beginning with the addition of 2mLof water,combine the extracts in the 200-mLvolumetric flask,dilute with methanol to volume,and mix.Transfer 10.0mLof this solution to a 100-mLvolumetric flask,add 2.0mLof Internal standard solution,dilute with a mixture of water and methanol (4:1)to volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Diazoxide.Calculate the quantity,in mg,of diazoxide (C8H7ClN2O2S)in each mLof the Oral Suspension taken by the formula: in which Cis the concentration,in µg per mL,of USP Diazoxide RSin the Standard preparation;Vis the volume,in mL,of Oral Suspension taken;and RUand RSare the peak response ratios obtained from the Assay preparationand the Standard preparation,respectively.