» Disulfiram Tablets contain not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C10H20N2S4.
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
A: Infrared Absorption 197K of a portion of powdered Tablets.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, as obtained in the Assay.
Disintegration 701: 15 minutes, the use of disks being omitted.
Uniformity of dosage units 905: meet the requirements.
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 C10H20N2S4 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.
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USP35NF30 Page 2945