Phensuximide
;)
2,5-Pyrrolidinedione,1-methyl-3-phenyl-,(±)-.
(±)-N-Methyl-2-phenylsuccinimide [86-34-0].
»Phensuximide contains not less than 97.0percent and not more than 103.0percent of C11H11NO2,calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Kñ.
and 74
Water,Method Iá921ñ:
not more than 1.0%.
Residue on ignition á281ñ:
not more than 0.5%.
Limit of cyanide—
Dissolve 1.0g in 10mLof warm alcohol,and add 3drops of ferrous sulfate TS,1mLof 1Nsodium hydroxide,and a few drops of ferric chloride TS.Warm gently,and finally acidify with 2Nsulfuric acid:no blue precipitate or blue color is formed within 15minutes.
Ordinary impurities á466ñ—
Test solution:
200mg of phensuximide per mLin methylene chloride.
Standard solutions:
1.0,2.0,and 4.0mg per mLin methylene chloride.
Application volume:
5µL.
Eluant:
a mixture of ethyl acetate and hexanes (1:1).
Visualization:
6.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Transfer about 200mg of Phensuximide,accurately weighed,to a 50-mLvolumetric flask.Dissolve in 40mLof alcohol,dilute with alcohol to volume,and mix.Transfer 5.0mLof this solution to a 50-mLvolumetric 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 400µg per mL,in 1-cm cells at the wavelength of maximum absorbance at about 258nm,with a suitable spectrophotometer,using alcohol as the blank.Calculate the quantity,in mg,of C11H11NO2in the Phensuximide taken by the formula:
0.5C(AU/AS),
in which Cis the concentration,in µg per mL,of USP Phensuximide RSin the Standard solution,and AUand ASare the absorbances of the solution from Phensuximide and the Standard solution,respectively.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1534
Phone Number:1-301-816-8330