|
Cefadroxil Tablets
»Cefadroxil Tablets contain not less than 90.0percent and not more than 120.0percent 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.
Identification—
Mix a quantity of powdered Tablets,equivalent to about 250mg of cefadroxil,with water to obtain a concentration of about 2mg of cefadroxil per mL,and filter:the filtrate so obtained responds to Identificationtest Bunder Cefadroxil.
Dissolution á711ñ—
Medium:
water;900mL.
Apparatus 2:
50rpm.
Time:
30minutes.
Procedure—
Determine the amount of C16H17N3O5Sdissolved from UVabsorbances at the wavelength of maximum absorbance at about 263nm 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 RSin the same medium.
Tolerances—
Not less than 75%(Q)of the labeled amount of C16H17N3O5Sis dissolved in 30minutes.
Uniformity of dosage units á905ñ:
meet the requirements.
Water,Method Iá921ñ:
not more than 8.0%.
Assay—
pH5.0buffer,Mobile phase,Standard preparation,and Chromatographic system—
Prepare as directed in the Assayunder Cefadroxil.
Assay preparation—
Weigh and finely powder not less than 10Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 200mg of cefadroxil,to a 200-mLvolumetric flask,dilute with pH5.0bufferto volume,and stir by mechanical means for 5minutes.Use this solution on the day prepared.
Procedure—
Proceed as directed for Procedurein the Assayunder Cefadroxil.Calculate the quantity,in mg,of C16H17N3O5Sin the portion of Tablets taken by the formula:
in which the terms are as defined therein.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 373
Phone Number:1-301-816-8335
|