Test solution— Prepare an aqueous dispersion of Tablets for Oral Suspension in 0.1Nhydrochloric acid containing 4mg of amoxicillin per mL.Use within 10minutes of preparation.

Application: 5µL.

Developing solvent system: a mixture of methanol,chloroform,water,and pyridine (90:80:30:1).

Procedure— Proceed as directed in the chapter.Dry the plate with the aid of a current of warm air for 10minutes.Locate the spots on the plate by spraying lightly with a solution of ninhydrin in alcohol containing 3mg per mL,and dry at 110for 15minutes.

Medium: water;900mL.

Apparatus 2: 75rpm.

Time: 30minutes.

Tolerances— Not less than 80%(Q)of the labeled amount of amoxicillin (C16H19N3O5S)is dissolved in 30minutes.

Diluent,Mobile phase,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Amoxicillin.

Assay preparation— Prepare a dispersion of 20Tablets for Oral Suspension using an accurately measured volume of water.Quantitatively dilute an accurately measured portion of the dispersion with Diluentto obtain a solution containing about 1.2mg of amoxicillin per mL.Pass a portion of the solution through a filter having a 1-µm or finer porosity,and use the filtrate as the Assay preparation.Use this solution within 6hours.

Procedure— Proceed as directed for Procedurein the Assayunder Amoxicillin.Calculate the quantity,in mg,of amoxicillin (C16H19N3O5S)in each Tablet for Oral Suspension taken by the formula: in which Lis the labeled quantity,in mg,of amoxicillin in each Tablet for Oral Suspension;Dis the concentration,in mg per mL,of amoxicillin in the Assay preparationon the basis of the number of Tablets for Oral Suspension taken,the labeled quantity of amoxicillin in each Tablet for Oral Suspension,and the extent of dilution;Cis the concentration,in mg per mL,of USP Amoxicillin RSin theStandard preparation;Pis the potency,in µg per mg,of the USP Amoxicillin RS;and rUandrSare the amoxicillin peak responses obtained from theAssay preparationand the Standard preparation,respectively.