Cefaclor for Oral Suspension
» Cefaclor for Oral Suspension is a dry mixture of Cefaclor and one or more suitable buffers, colors, diluents, and flavors. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C15H14ClN3O4S.
Packaging and storage Preserve in tight containers.
USP Reference standards 11
USP Cefaclor Delta-3 Isomer RS
Identification The retention time of the major peak for cefaclor 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 5.0, in the suspension constituted as directed in the labeling.
Water, Method I 921: not more than 2.0%.
Solvent, Blank solution, Solution A, Solution B, Mobile phase, Standard solution, System suitability solution, and Chromatographic system Proceed as directed for Related compounds under Cefaclor.
Test solution Constitute Cefaclor for Oral Suspension as directed in the labeling. Transfer an accurately measured portion of Cefaclor for Oral Suspension, freshly mixed and free from air bubbles, equivalent to about 50 mg of cefaclor, to a 10-mL volumetric flask. Dissolve in Solvent, using brief sonication, if necessary, to achieve dissolution. Avoid heating. Dilute with Solvent to volume, mix, and filter. Use this Test solution within 3 hours if stored at room temperature, or within 20 hours when stored under refrigeration.
Procedure Separately inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak area responses for all the peaks. Calculate the mg of each related compound in the portion of Cefaclor for Oral Suspension taken by the formula:
0.01CP(ri / rS)in which the terms are as defined for Related compounds under Cefaclor. Not more than 1.0% of any individual cefaclor-related compound is found; and the sum of all cefaclor-related compounds found is not more than 3.0%, not including the contribution of any peak that gives a result of less than 0.1%.
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system Proceed as directed in the Assay under Cefaclor.
Assay preparation Constitute Cefaclor for Oral Suspension as directed in the labeling. Transfer an accurately measured portion of the resulting suspension, freshly mixed and free from air bubbles, dilute quantitatively with Mobile phase to obtain a final solution containing about 0.3 mg of cefaclor per mL. Sonicate if necessary to ensure complete dissolution of the cefaclor. Filter to obtain the clear Assay preparation.
Procedure Proceed as directed in the Assay under Cefaclor. Calculate the quantity, in mg, of C15H14ClN3O4S in the portion of the constituted Cefaclor for Oral Suspension taken by the formula:
VU (WS / 50)(P/1000)(rU / rS)in which VU is the final volume, in mL, of the Assay preparation, and the other terms are as defined therein.
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USP35NF30 Page 2527Pharmacopeial Forum: Volume No. 28(4) Page 1087