Identification
A:
Infrared Absorption á197Kñof a portion of powdered Tablets.
B:
The retention time of the major peak in the chromatogram of the Assay preparationcorresponds to that of the Standard preparation,as obtained in the Assay.
Assay
Buffer solution A,Buffer solution B,Mobile phase,Standard preparation,and Chromatographic system
Proceed as directed in the
Assayunder
Disulfiram.
Assay preparation
Weigh and finely powder not fewer than 20Tablets.Transfer an accurately weighed portion of the powder,equivalent to about 100mg of disulfiram,to a 100-mLvolumetric flask,add about 70mLof alcohol and swirl,sonicate for 5minutes,and shake by mechanical means for 30minutes or until dissolved.Dilute with alcohol to volume,mix,and filter.[NOTEDiscard this solution after 5days.]Quantitatively dilute this solution with Mobile phaseto obtain the Assay preparationhaving a concentration of about 0.02mg per mL.[NOTEPrepare the Assay preparation fresh daily.]
Procedure
Proceed as directed for
Procedurein the
Assayunder
Disulfiram.Calculate the quantity,in mg,of C
10H
20N
2S
4in the portion of Tablets taken by the formula:
5C(rU/rS),
in which
Cis the concentration,in µg per mL,of
USP Disulfiram RSin the
Standard preparation;and
rUand
rSare the peak responses obtained from the
Assay preparationand the
Standard preparation,respectively.