For solid packaged in single-unit containers: meets the requirements.

Tetrabutylammonium hydroxide solution, Mobile phase, pH 7.0 Phosphate buffer, Resolution solution, Standard preparation, and Chromatographic system— Proceed as directed in the Assay under Cefixime.

Assay preparation— Constitute Cefixime for Oral Suspension as directed in the labeling. Quantitatively dilute an accurately measured volume of the suspension thus obtained, freshly mixed and free from air bubbles, with pH 7.0 Phosphate buffer to obtain a solution having a concentration of about 0.2 mg of cefixime per mL.

Procedure— Proceed as directed in the Assay under Cefixime. Calculate the quantity, in mg, of cefixime (C16H15N5O7S2) in each mL of the constituted suspension prepared from the Cefixime for Oral Suspension taken by the formula: in which L is the labeled quantity, in mg per mL, of cefixime in the constituted suspension; D is the concentration, in mg per mL, of cefixime in the Assay preparation on the basis of the labeled quantity in the constituted suspension and the extent of dilution; and the other terms are as defined therein.