U.S. PHARMACOPEIA

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Cefixime for Oral Suspension
» Cefixime for Oral Suspension is a dry mixture of Cefixime and one or more suitable diluents, flavors, preservatives, and suspending agents. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefixime (C16H15N5O7S2) per mL when constituted as directed in the labeling.
Packaging and storage— Preserve in tight containers.
Labeling— Label it to indicate that the cefixime contained therein is in the trihydrate form.
Identification— The retention time of the major peak in cefixime in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Uniformity of dosage units 905—
FOR SOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 2.5 and 4.5, in the suspension constituted as directed in the labeling.
Water, Method I 921: not more than 2.0%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
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:
(LC / D)(rU / rS),
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.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 412
Phone Number : 1-301-816-8223