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Phensuximide
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C11H11NO2 189.21

2,5-Pyrrolidinedione, 1-methyl-3-phenyl-, (±)-.
(±)-N-Methyl-2-phenylsuccinimide [86-34-0].
» Phensuximide contains not less than 97.0 percent and not more than 103.0 percent of C11H11NO2, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight containers.
Identification—
B: Ultraviolet Absorption 197U
Solution: 400 µg per mL.
Medium: alcohol.
Melting range, Class I 741: between 68 and 74.
Water, Method I 921: not more than 1.0%.
Residue on ignition 281: not more than 0.5%.
Limit of cyanide— Dissolve 1.0 g in 10 mL of warm alcohol, and add 3 drops of ferrous sulfate TS, 1 mL of 1 N sodium hydroxide, and a few drops of ferric chloride TS. Warm gently, and finally acidify with 2 N sulfuric acid: no blue precipitate or blue color is formed within 15 minutes.
Ordinary impurities 466
Test solution: 200 mg of phensuximide per mL in methylene chloride.
Standard solutions: 1.0, 2.0, and 4.0 mg per mL in methylene chloride.
Application volume: 5 µL.
Eluant: a mixture of ethyl acetate and hexanes (1:1).
Visualization: 6.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer about 200 mg of Phensuximide, accurately weighed, to a 50-mL volumetric flask. Dissolve in 40 mL of alcohol, dilute with alcohol to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with alcohol to volume, and mix. Concomitantly determine the absorbances of this solution and of a Standard solution of USP Phensuximide RS, in the same medium having a known concentration of about 400 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 258 nm, with a suitable spectrophotometer, using alcohol as the blank. Calculate the quantity, in mg, of C11H11NO2 in the Phensuximide taken by the formula:
0.5C(AU / AS),
in which C is the concentration, in µg per mL, of USP Phensuximide RS in the Standard solution, and AU and AS are the absorbances of the solution from Phensuximide and the Standard solution, respectively.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1704
Phone Number : 1-301-816-8330