Cefpodoxime Proxetil for Oral Suspension
»Cefpodoxime Proxetil for Oral Suspension contains Cefpodoxime Proxetil and one or more buffers,suspending agents,sweeteners,flavorings,and preservatives.When constituted as directed in the labeling,it contains the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled amount of cefpodoxime (C15H17N5O6S2).
Packaging and storage— Preserve in tight containers,at a temperature not exceeding 30.Store the constituted Oral Suspension in a refrigerator.
USP Reference standards á11ñ— USP Cefpodoxime Proxetil RS.
Identification— The retention times of the cefpodoxime proxetil R-epimer peak and the cefpodoxime proxetil S-epimer peak in the chromatogram of the Assay preparation correspond to those 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 4.0and 5.5,in the suspension constituted as directed in the labeling.
Water á921ñ: not more than 1.5%.
Assay—
Mobile phase,Diluent,andChromatographic system— Prepare as directed in the Assayunder Cefpodoxime Proxetil.
Standard preparation— Transfer about 30mg of USP Cefpodoxime Proxetil RS,accurately weighed,to a 50-mLvolumetric flask,dissolve in 5mLof methanol,dilute with Diluentto volume,and mix.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,dilute with Diluentto volume,and mix.Pass through a filter having a 0.45-µm or finer porosity.
Assay preparation— Constitute a container of Cefpodoxime Proxetil for Oral Suspension as directed in the labeling.Shake the resulting suspension thoroughly,and determine its density.Transfer an accurately weighed quantity of the suspension,equivalent to about 50mg of cefpodoxime,to a 100-mLvolumetric flask.Add 10mLof water,and shake to disperse.Add 20mLof acetonitrile,and sonicate for 15minutes.Cool to room temperature,dilute with Diluentto volume,and mix.Transfer 5.0mLof this solution to a 100-mLvolumetric flask,dilute with Diluentto volume,mix,and pass through a filter having a 0.45-µm or finer porosity.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg of cefpodoxime (C15H17N5O6S2)in the portion of Oral Suspension taken by the formula:
2CP(rU/rS),
in which Cis the concentration,in mg per mL,of USP Cefpodoxime Proxetil RSin the Standard preparation;Pis the designated potency,in µg per mg,of cefpodoxime (C15H17N5O6S2)in USP Cefpodoxime Proxetil RS;and rUand rSare the sums of the peak responses for cefpodoxime proxetil S-epimer and cefpodoxime proxetil R-epimer obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 398
Pharmacopeial Forum:Volume No.28(1)Page 48
Phone Number:1-301-816-8335