Iodipamide
;)
Benzoic acid,3,3¢-[(1,6-dioxo-1,6-hexanediyl)diimino]bis[2,4,6-triiodo-.
3,3¢-(Adipoyldiimino)bis[2,4,6-triiodobenzoic acid] [606-17-7].
»Iodipamide contains not less than 98.0percent and not more than 102.0percent of C20H14I6N2O6,calculated on the anhydrous basis.
Packaging and storage—
Preserve in well-closed containers.Store at 25
,excursions permitted between 15and 30.
,excursions permitted between 15and 30.
Identification—
A:
It responds to the Thin-Layer Chromatographic Identification Test á201ñ,the test solution and the Standard solution being prepared at a concentration of 1mg per mLin an 0.8in 1000solution of sodium hydroxide in methanol,the solvent mixture being a mixture of chloroform,methanol,and ammonium hydroxide (20:10:2),and short-wavelength UVlight being used to locate the spots.
B:
Heat about 500mg in a suitable crucible:violet vapors are evolved.
Water,Method Iá921ñ:
not more than 1.0%.
Residue on ignition á281ñ:
not more than 0.1%.
Free aromatic amine—
Transfer 1.0g to a 50-mLvolumetric flask,and add 12.5mLof water and 2.5mLof 1Nsodium hydroxide.To a second 50-mLvolumetric flask transfer 4mLof water,10mLof 0.1Nsodium hydroxide,and 1.0mLof a Standard solution prepared by dissolving a suitable quantity of USP3-Amino-2,4,6-triiodobenzoic Acid RSin 0.1Nsodium hydroxide (use 0.2mLof the 0.1Nsodium hydroxide for each 5.0mg of the Reference standard)and by diluting with water to obtain a solution having a known concentration of 500µg per mL.Proceed as directed in the test for Free aromatic amineunder Diatrizoate Meglumine,beginning with “To a third 50-mLvolumetric flask add 5mLof water.”
Other requirements—
It meets the requirements of the tests for Iodine and iodideand Heavy metalsunder Diatrizoic Acid.
Assay—
Transfer about 300mg of Iodipamide,accurately weighed,to a glass-stoppered,125-mLconical flask,add 30mLof 1.25Nsodium hydroxide and 500mg of powdered zinc,connect the flask to a reflux condenser,and reflux the mixture for 30minutes.Cool the flask to room temperature,rinse the condenser with 20mLof water,disconnect the flask from the condenser,and filter the mixture.Rinse the filter and the flask thoroughly,adding the rinsings to the filtrate.Add 5mLof glacial acetic acid and 1mLof tetrabromophenolphthalein ethyl ester TS,and titrate with 0.05Nsilver nitrate VSuntil the yellow precipitate just turns green.Each mLof 0.05Nsilver nitrate is equivalent to 9.498mg of C20H14I6N2O6.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1038
Pharmacopeial Forum:Volume No.29(6)Page 1907
Phone Number:1-301-816-8305