Cefadroxil Capsules
» Cefadroxil Capsules contain the equivalent of 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— Capsules prepared using the hemihydrate form of Cefadroxil are so labeled.
USP Reference standards 11
USP Cefadroxil RS Click to View Structure
Identification— Mix the contents of 1 Capsule 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.
Dissolution 711
Medium: water; 900 mL.
Apparatus 1: 100 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 80% (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 7.0%.
Assay—
pH 5.0 Buffer, Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Cefadroxil.
Assay preparation— Remove, as completely as possible, the contents of not fewer than 10 Capsules, and weigh. Mix, and 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.
Procedure— Proceed as directed for Procedure in the Assay under Cefadroxil. Calculate the quantity, in mg, of C16H17N3O5S in the portion of Capsules contents taken by the formula:
0.2CE(rU / rS)
in which the terms are as defined therein.
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