Propylthiouracil
(proe'' pil thye'' oh ure' a sil).
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C7H10N2OS 170.23

4(1H)-Pyrimidinone, 2,3-dihydro-6-propyl-2-thioxo-.
6-Propyl-2-thiouracil [51-52-5].
»Propylthiouracil contains not less than 98.0 percent and not more than 100.5 percent of C7H10N2OS, calculated on the dried basis.
Packaging and storage— Preserve in well-closed, light-resistant containers.
USP Reference standards 11
USP Propylthiouracil RS Click to View Structure
Identification, Infrared Absorption 197K.
Melting range 741: between 218 and 221.
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Selenium 291: 0.003%, a 200-mg specimen being used.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Application volume: 10 µL.
Eluant: a mixture of toluene, ethyl acetate, and formic acid (50:45:5), in a nonequilibrated chamber.
Visualization: 1.
Assay— Weigh accurately about 300 mg of Propylthiouracil, transfer to a 500-mL conical flask, and add 30 mL of water. Add from a buret about 30 mL of 0.1 N sodium hydroxide VS, heat to boiling, and agitate until solution is complete. Wash down any particles on the wall of the flask with a few mL of water, then add about 50 mL of 0.1 N silver nitrate while mixing, and boil gently for 7 minutes. Cool to room temperature, and continue to titrate with 0.1 N sodium hydroxide VS, determining the endpoint potentiometrically, using a glass-calomel electrode system. Each mL of 0.1 N sodium hydroxide is equivalent to 8.512 mg of C7H10N2OS.
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USP35–NF30 Page 4472