(dye sul' fi ram).
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.
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. [NoteDiscard this solution after 5 days. ]
Standard solution: 0.02 mg/mL of USP Disulfiram RS from the Standard stock solution diluted with Mobile phase. [NotePrepare 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. [NoteDiscard this solution after 5 days. ]
Sample solution: 0.02 mg/mL of Disulfiram from the Sample stock solution diluted with Mobile phase. [NotePrepare the Sample solution fresh daily. ]
Detector: UV 250 nm
Column: 4-mm × 15-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection size: 20 µL
Sample: Standard solution
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
Acceptance criteria: 98.0%102.0%
• Residue on Ignition 281: NMT 0.1%
• Selenium 291: 30 ppm
[NotePerform this test only if selenium is a known inorganic process impurity. ]
• Packaging and Storage: Preserve in tight, light-resistant containers.
• USP Reference Standards 11
Auxiliary Information Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2944Pharmacopeial Forum: Volume No. 35(4) Page 848