» Cefadroxil Tablets contain not less than 90.0 percent and not more than 120.0 percent of the labeled amount of C16H17N3O5S.
Packaging and storage Preserve in tight containers.
Labeling The Tablets prepared using the hemihydrate form of Cefadroxil are so labeled.
USP Reference standards 11
Identification Mix a quantity of powdered Tablets, equivalent to about 250 mg of cefadroxil, with water to obtain a concentration of about 2 mg of cefadroxil per mL, and filter: the filtrate so obtained responds to Identification test B under Cefadroxil.
Medium: water; 900 mL.
Apparatus 2: 50 rpm.
Time: 30 minutes.
Procedure Determine the amount of C16H17N3O5S dissolved from UV absorbances at the wavelength of maximum absorbance at about 263 nm of filtered portions of the solution under test, suitably diluted with water if necessary, in comparison with a Standard solution having a known concentration of USP Cefadroxil RS in the same medium.
Tolerances Not less than 75% (Q) of the labeled amount of C16H17N3O5S is dissolved in 30 minutes.
Uniformity of dosage units 905: meet the requirements.
Water, Method I 921: not more than 8.0%.
pH 5.0 Buffer, Mobile phase, Standard preparation, and Chromatographic system Prepare as directed in the Assay under Cefadroxil.
Assay preparation Weigh and finely powder not fewer than 10 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 200 mg of cefadroxil, to a 200-mL volumetric flask, dilute with pH 5.0 Buffer to volume, and stir by mechanical means for 5 minutes. Use this solution on the day prepared.
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USP35NF30 Page 2531