Disulfiram Tablets
»Disulfiram Tablets contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C10H20N2S4.
Packaging and storage— Preserve in tight,light-resistant containers.
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.
Disintegration á701ñ: 15minutes,the use of disks being omitted.
Uniformity of dosage units á905ñ: meet the requirements.
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.[NOTE—Discard this solution after 5days.]Quantitatively dilute this solution with Mobile phaseto obtain the Assay preparationhaving a concentration of about 0.02mg per mL.[NOTE—Prepare the Assay preparation fresh daily.]
Procedure— Proceed as directed for Procedurein the Assayunder Disulfiram.Calculate the quantity,in mg,of C10H20N2S4in 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.
Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 679
Phone Number:1-301-816-8165