Cefadroxil Capsules
»Cefadroxil Capsules contain 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.
Labeling— Capsules prepared using the hemihydrate form of Cefadroxil are so labeled.
Identification— Mix the contents of 1Capsule 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 1: 100rpm.
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 80%(Q)of the labeled amount of C16H17N3O5Sis dissolved in 30minutes.
Uniformity of dosage units á905ñ: meet the requirements.
Water,Method Iá921ñ: not more than 7.0%.
Assay—
pH5.0buffer,Mobile phase,Standard preparation,andChromatographic system— Proceed as directed in the Assayunder Cefadroxil.
Assay preparation— Remove,as completely as possible,the contents of not less than 10Capsules,and weigh.Mix,and 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 Capsules contents taken by the formula:
0.2CE(rU/rS),
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 372
Phone Number:1-301-816-8335