Dissolution 711
Medium:
0.05 M pH 6.8 potassium phosphate buffer; 900 mL.
Apparatus 1:
100 rpm.
Time:
30 minutes.
Procedure
Determine the amount of cloxacillin (C
19H
18ClN
3O
5S) dissolved by employing the method set forth in the
Assay, in comparison with a Standard solution having a known concentration of
USP Cloxacillin Sodium RS in the
Dissolution Medium.
Tolerances
Not less than 80% (Q) of the labeled amount of cloxacillin (C19H18ClN3O5S) is dissolved in 30 minutes.
Assay
Buffer, Mobile phase, Standard preparation, and Chromatographic system
Proceed as directed in the
Assay under
Cloxacillin Sodium.
Assay preparation
Weigh and finely powder the contents of not fewer than 10 Capsules. Transfer an accurately weighed quantity of the powder, equivalent to about 100 mg of cloxacillin, to a 200-mL volumetric flask, dilute with Buffer to volume, mix, and stir for 10 minutes. Filter about 25 mL of this mixture, discarding the first 5 mL of the filtrate. Use the clear filtrate as the Assay preparation.
Procedure
Proceed as directed for
Procedure in the
Assay under
Cloxacillin Sodium. Calculate the quantity, in mg, of cloxacillin (C
19H
18ClN
3O
5S) in the portion of Capsule contents taken by the formula:
0.2CE(rU / rS),
in which the terms are as defined therein.