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 90.0 percent and not more than 110.0 percent 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.
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 905
for solid packaged in single-unit containers: meets the requirements.
Deliverable volume 698: meets the requirements.
pH 791: between 4.0 and 5.5, in the suspension constituted as directed in the labeling.
Water 921: not more than 1.5%.
Assay—
Mobile phase, Diluent, and Chromatographic system— Prepare as directed in the Assay under Cefpodoxime Proxetil.
Standard preparation— Transfer about 30 mg of USP Cefpodoxime Proxetil RS, accurately weighed, to a 50-mL volumetric flask, dissolve in 5 mL of methanol, dilute with Diluent to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Diluent to 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 50 mg of cefpodoxime, to a 100-mL volumetric flask. Add 10 mL of water, and shake to disperse. Add 20 mL of acetonitrile, and sonicate for 15 minutes. Cool to room temperature, dilute with Diluent to volume, and mix. Transfer 5.0 mL of this solution to a 100-mL volumetric flask, dilute with Diluent to volume, mix, and pass through a filter having a 0.45-µm or finer porosity.
Procedure— Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into 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 C is the concentration, in mg per mL, of USP Cefpodoxime Proxetil RS in the Standard preparation; P is the designated potency, in µg per mg, of cefpodoxime (C15H17N5O6S2) in USP Cefpodoxime Proxetil RS; and rU and rS are the sums of the peak responses for cefpodoxime proxetil S-epimer and cefpodoxime proxetil R-epimer obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
Scientist
1-301-816-8161
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
USP32–NF27 Page 1854
Pharmacopeial Forum: Volume No. 28(1) Page 48
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.