Cefprozil for Oral Suspension
» Cefprozil for Oral Suspension is a dry mixture of Cefprozil and one or more suitable buffers, flavors, preservatives, suspending agents, and sweeteners. It contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of cefprozil (C18H19 N3O5S).
Packaging and storage Preserve in tight containers.
USP Reference standards 11
USP Cefprozil (Z)-Isomer RS
USP Cefprozil (E)-Isomer RS
A: Transfer a portion of the Cefprozil for Oral Suspension powder, equivalent to about 50 mg of cefprozil, to a 20-mL glass-stoppered test tube, add 10 mL of a mixture of acetone and 0.1 N hydrochloric acid (4:1), shake for 5 minutes, and allow to settle. Use the supernatant as the test solution. Dissolve a suitable quantity of USP Cefprozil (Z)-Isomer RS in a mixture of acetone and 0.1 N hydrochloric acid (4:1) to obtain a Standard solution containing 5 mg per mL. Apply separate 10-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in an equilibrated chromatographic chamber with a solvent system consisting of a mixture of butyl alcohol, water, and glacial acetic acid (60:20:20) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and allow the plate to air-dry in a hood. Place the dry plate in a chamber containing iodine vapors. Examine the plate, and locate the spots: the RF value of the principal spot in the chromatogram obtained from the Test solution corresponds to that obtained from the Standard solution.
B: The retention times of the cefprozil (Z)-isomer and cefprozil (E)-isomer peaks in the chromatogram of the Assay preparation correspond to those of the Standard preparations, as obtained in the Assay.
Uniformity of dosage units 905
for solids packaged in single-unit containers: meets the requirements.
Deliverable volume 698
for powder packaged in multiple-unit containers: meets the requirements.
pH 791: between 4.0 and 6.0, in the Cefprozil for Oral Suspension constituted as directed in the labeling.
Water, Method I 921: not more than 3.0%.
Mobile phase, Standard cefprozil (Z)-isomer preparation, Standard cefprozil (E)-isomer preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Cefprozil.
Assay preparation Constitute 1 container of Cefprozil for Oral Suspension as directed in the labeling. Transfer an accurately measured volume of the Cefprozil for Oral Suspension, freshly mixed and free from air bubbles, equivalent to about 250 mg of cefprozil, to a 250-mL volumetric flask, dilute with water to volume, and mix, sonicating briefly. Transfer 15.0 mL of this solution to a 50-mL volumetric flask, dilute with water to volume, and mix. Pass a portion of this solution through a filter having a 0.5-µm or finer porosity, and use the filtrate as the Assay preparation. [noteUse this solution within 6 hours. ]
Procedure Proceed as directed for Procedure in the Assay under Cefprozil. Calculate the quantity, in mg, of cefprozil (Z)-isomer and cefprozil (E)-isomer in each mL of the Cefprozil for Oral Suspension taken by the formula:
0.833(CP/V)(rU / rS)in which V is the volume, in mL, of Cefprozil for Oral Suspension taken, and the other terms are as defined therein. Calculate the quantity, in mg, of cefprozil (C18H19N3O5S) in each mL of Cefprozil for Oral Suspension taken by adding the values, in mg per mL, obtained from the cefprozil (Z)-isomer and from the cefprozil (E)-isomer.
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USP35NF30 Page 2570Pharmacopeial Forum: Volume No. 30(1) Page 83