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 90.0percent and not more than 120.0percent of the labeled amount of cefixime (C16H15N5O7S2)per mLwhen 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 preparationcorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Uniformity of dosage units á905ñ—
FORSOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 2.5and 4.5,in the suspension constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 2.0%.
Assay—
Tetrabutylammonium hydroxide solution,Mobile phase,pH7.0Phosphate buffer,Resolution solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder 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 pH7.0Phosphate bufferto obtain a solution having a concentration of about 0.2mg of cefixime per mL.
Procedure— Proceed as directed in the Assayunder Cefixime.Calculate the quantity,in mg,of cefixime (C16H15N5O7S2)in each mLof the constituted suspension prepared from the Cefixime for Oral Suspension taken by the formula:
(LC/D)(rU/rS),
in which Lis the labeled quantity,in mg per mL,of cefixime in the constituted suspension,Dis the concentration,in mg per mL,of cefixime in the Assay preparationon 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:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 380
Phone Number:1-301-816-8335