Dissolution 711
Medium:
water; 900 mL.
Apparatus 1:
100 rpm.
Time:
30 minutes.
Procedure
Determine the amount of C
16H
17N
3O
5S 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.
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 C
16H
17N
3O
5S in the portion of Capsules contents taken by the formula:
0.2CE(rU / rS),
in which the terms are as defined therein.