Assay
Buffer solution A, Buffer solution B, Mobile phase, Standard preparation, and Chromatographic system
Proceed as directed in the
Assay under
Disulfiram.
Assay preparation
Weigh and finely powder not fewer than 20 Tablets. Transfer an accurately weighed portion of the powder, equivalent to about 100 mg of disulfiram, to a 100-mL volumetric flask, add about 70 mL of alcohol and swirl, sonicate for 5 minutes, and shake by mechanical means for 30 minutes or until dissolved. Dilute with alcohol to volume, mix, and filter. [NOTEDiscard this solution after 5 days.] Quantitatively dilute this solution with Mobile phase to obtain the Assay preparation having a concentration of about 0.02 mg per mL. [NOTEPrepare the Assay preparation fresh daily.]
Procedure
Proceed as directed for
Procedure in the
Assay under
Disulfiram. Calculate the quantity, in mg, of C
10H
20N
2S
4 in the portion of Tablets taken by the formula:
5C(rU / rS),
in which
C is the concentration, in µg per mL, of
USP Disulfiram RS in the
Standard preparation; and
rU and
rS are the peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.