Cefadroxil for Oral Suspension
»Cefadroxil for Oral Suspension is a dry mixture of Cefadroxil 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 C16H17N3O5S.
Packaging and storage— Preserve in tight containers.
Identification— Constitute 1container of Cefadroxil for Oral Suspension as directed in the labeling.Mix a portion of the resulting suspension with water to obtain a concentration of about 2mg of cefadroxil per mL,and filter:the filtrate so obtained responds to Identificationtest Bunder Cefadroxil.
Uniformity of dosage units á905ñ—
FORSOLID PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.
Deliverable volume á698ñ: meets the requirements.
pHá791ñ: between 4.5and 6.0,in the suspension constituted as directed in the labeling.
Water,Method Iá921ñ: not more than 2.0%.
Assay—
pH5.0buffer,Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Cefadroxil.
Assay preparation— Constitute a container of Cefadroxil for Oral Suspension as directed in the labeling.Transfer an accurately measured volume of the oral suspension thus obtained,equivalent to about 250mg of cefadroxil,to a 250-mLvolumetric flask,dilute with pH5.0bufferto volume,and stir by mechanical means for 5minutes.Filter about 25mLof the resulting solution through a suitable filter of 0.8µm or finer porosity,and use the clear filtrate as the Assay preparation.Use this solution on the day prepared.
Procedure— Proceed as directed for Procedurein the Assayunder Cefadroxil.Calculate the quantity,in mg,of C16H17N3O5Sin each mLof Cefadroxil for Oral Suspension taken by the formula:
0.25(CE/V)(rU/rS),
in which Vis the volume,in mL,of Cefadroxil for Oral Suspension taken,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 372
Phone Number:1-301-816-8335