(dye sul' fi ram).
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C10H20N2S4 296.54
Thioperoxydicarbonic diamide [(H2N)C(S)]2S2, tetraethyl-;    
Bis(diethylthiocarbamoyl) disulfide     [97-77-8].
Disulfiram contains NLT 98.0% and NMT 102.0% of C10H20N2S4.
•  B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
•  Procedure
Buffer:  6.8 g/L of monobasic potassium phosphate in water. Adjust with 45% potassium hydroxide solution to a pH of 7.0.
Mobile phase:  Methanol and Buffer (7:3)
Standard stock solution:  1 mg/mL of USP Disulfiram RS in alcohol. [Note—Discard this solution after 5 days. ]
Standard solution:  0.02 mg/mL of USP Disulfiram RS from the Standard stock solution diluted with Mobile phase. [Note—Prepare the Standard solution fresh daily. ]
Sample stock solution:  Transfer 50 mg of Disulfiram to a 50-mL volumetric flask, add 40 mL of alcohol, sonicate for 5 min to completely dissolve, cool, and dilute with alcohol to volume. [Note—Discard this solution after 5 days. ]
Sample solution:  0.02 mg/mL of Disulfiram from the Sample stock solution diluted with Mobile phase. [Note—Prepare the Sample solution fresh daily. ]
Chromatographic system 
Mode:  LC
Detector:  UV 250 nm
Column:  4-mm × 15-cm; 5-µm packing L1
Flow rate:  1 mL/min
Injection size:  20 µL
System suitability 
Sample:  Standard solution
Suitability requirements 
Column efficiency:  NLT 1800 theoretical plates
Tailing factor:  NMT 2
Relative standard deviation:  NMT 2.0%
Samples:  Standard solution and Sample solution
Calculate the percentage of C10H20N2S4 in the portion of Disulfiram taken:
Result = (rU/rS) × (CS/CU) × 100
rU== peak response from the Sample solution
rS== peak response from the Standard solution
CS== concentration of USP Disulfiram RS in the Standard solution (µg/mL)
CU== concentration of Disulfiram in the Sample solution (µg/mL)
Acceptance criteria:  98.0%–102.0%
Inorganic Impurities 
•  Residue on Ignition 281: NMT 0.1%
•  Selenium 291: 30 ppm
[Note—Perform this test only if selenium is a known inorganic process impurity. ]
•  Packaging and Storage: Preserve in tight, light-resistant containers.
•  USP Reference Standards 11
USP Disulfiram RS Click to View Structure
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ravi Ravichandran, Ph.D.
Principal Scientific Liaison
(SM42010) Monographs - Small Molecules 4
Reference Standards RS Technical Services
USP35–NF30 Page 2944
Pharmacopeial Forum: Volume No. 35(4) Page 848