Medium: water; 900 mL.

Apparatus 2: 75 rpm.

Time: 30 minutes; or 45 minutes where the Tablets are labeled as chewable.

Procedure— Determine the amount of amoxicillin (C16H19N3O5S) and clavulanic acid (C8H9NO5) dissolved, employing the procedure set forth in the Assay, making any necessary volumetric adjustments.

Tolerances— Not less than 85% (Q) of the labeled amount of C16H19N3O5S and not less than 80% (Q) of the labeled amount of C8H9NO5 are dissolved in 30 minutes.

for tablets labeled as chewable— Not less than 80% (Q) of the labeled amounts of C16H19N3O5S and C8H9NO5 is dissolved in 45 minutes.

pH 4.4 Sodium phosphate buffer, Mobile phase, Standard preparation, and Chromatographic system— Prepare as directed in the Assay under Amoxicillin and Clavulanate Potassium for Oral Suspension.

Assay preparation— Dissolve not fewer than 10 Tablets, accurately counted, in water with the aid of mechanical stirring, transfer to a suitable volumetric flask, dilute with water to volume, and mix. Filter a portion of this solution, discarding the first 10 mL of the filtrate. Dilute an accurately measured volume of the filtrate quantitatively and stepwise with water to obtain a solution containing about 0.5 mg of amoxicillin per mL. Use this Assay preparation within 1 hour.

Procedure— Proceed as directed for Procedure in the Assay under Amoxicillin and Clavulanate Potassium for Oral Suspension. Calculate the quantity, in mg, of amoxicillin (C16H19N3O5S) in each Tablet taken by the formula: in which L is the labeled quantity, in mg, of amoxicillin in each Tablet; D is the concentration, in mg per mL, of amoxicillin in the Assay preparation on the basis of the number of Tablets taken, the labeled quantity of amoxicillin in each Tablet, and the extent of dilution; C is the concentration, in mg per mL, of USP Amoxicillin RS in the Standard preparation; P is the potency, in µg of amoxicillin per mg, of USP Amoxicillin RS, and rU and rS are the amoxicillin peak responses obtained from the Assay preparation and the Standard preparation, respectively. Calculate the quantity, in mg, of clavulanic acid (C8H9NO5) in each Tablet taken by the formula: in which L is the labeled quantity, in mg, of clavulanic acid in each Tablet; D is the concentration, in mg per mL, of clavulanic acid in the Assay preparation, on the basis of the number of Tablets taken, the labeled quantity of clavulanic acid in each Tablet, and the extent of dilution; C is the concentration, in mg per mL, of USP Clavulanate Lithium RS in the Standard preparation; P is the designated potency, in µg of clavulanic acid per mg, of USP Clavulanate Lithium RS; and rU and rS are the clavulanic acid peak responses obtained from the Assay preparation and the Standard preparation, respectively.