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 90.0percent and not more than 120.0percent of the labeled amount of C15H14ClN3O4S.
Packaging and storage— Preserve in tight containers.
USP Reference standards á11ñ— USP Cefaclor RS.USP Cefaclor,Delta-3Isomer RS.
Identification— The retention time of the major peak for cefaclor in the chromatogram of the Assay preparationcorresponds to that 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 2.5and 5.0,in the suspension constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 2.0%.
Related compounds—
Solvent,Blank solution,Solution A,Solution B,Mobile phase,Standard solution,System suitability solution,andChromatographic system— Proceed as directed for Related compoundsunder 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 50mg of cefaclor,to a 10-mLvolumetric flask.Dissolve in Solvent,using brief sonication,if necessary,to achieve dissolution.Avoid heating.Dilute with Solventto volume,mix,and filter.Use this Test solutionwithin 3hours if stored at room temperature,or within 20hours when stored under refrigeration.
Procedure— Separately inject equal volumes (about 20µL)of the Standard solutionand the Test solutioninto 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 compoundsunder 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,andChromatographic system— Proceed as directed in the Assayunder 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 phaseto obtain a final solution containing about 0.3mg 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 Assayunder Cefaclor.Calculate the quantity,in mg,of C15H14ClN3O4Sin the portion of the constituted Cefaclor for Oral Suspension taken by the formula:
VU(WS/50)(P/1000)(rU/rS),
in which VUis the final volume,in mL,of the Assay preparation,and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 370
Pharmacopeial Forum:Volume No.28(4)Page 1087
Phone Number:1-301-816-8335
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