Dissolution á711ñ
Medium:
0.05MpH6.8potassium phosphate buffer;900mL.
Apparatus 1:
100rpm.
Time:
30minutes.
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 RSin the
Dissolution Medium.
Tolerances
Not less than 80%(Q)of the labeled amount of cloxacillin (C19H18ClN3O5S)is dissolved in 30minutes.
Assay
Buffer,Mobile phase,Standard preparation,and Chromatographic system
Proceed as directed in the
Assayunder
Cloxacillin Sodium.
Assay preparation
Weigh and finely powder the contents of not fewer than 10Capsules.Transfer an accurately weighed quantity of the powder,equivalent to about 100mg of cloxacillin,to a 200-mLvolumetric flask,dilute with Bufferto volume,mix,and stir for 10minutes.Filter about 25mLof this mixture,discarding the first 5mLof the filtrate.Use the clear filtrate as the Assay preparation.
Procedure
Proceed as directed for
Procedurein the
Assayunder
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.