Packaging and storage
Preserve in tight containers.
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.
pH 791:
between 2.5 and 5.0, in the suspension constituted as directed in the labeling.
Related compounds
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%.
Assay
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 C
15H
14ClN
3O
4S 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.
Auxiliary Information
Staff Liaison :
Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29NF24 Page 401
Pharmacopeial Forum : Volume No. 28(4) Page 1087
Phone Number : 1-301-816-8223