Iodipamide Meglumine Injection
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C20H14I6N2O6·2C7H17NO5 1530.19

Benzoic acid,3,3¢-[(1,6-dioxo-1,6-hexanediyl)diimino]bis[2,4,6-triiodo-,compd.with 1-deoxy-1-(methylamino)-D-glucitol(1:2).
1-Deoxy-1-(methylamino)-D-glucitol 3,3¢-(adipoyldiimino)bis[2,4,6-triiodobenzoate](2:1)(salt) [3521-84-4].
»Iodipamide Meglumine Injection is a sterile solution of Iodipamide in Water for Injection,prepared with the aid of Meglumine.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of iodipamide meglumine (C20H14I6N2O6·2C7H17NO5).It may contain small amounts of suitable buffers and of Edetate Calcium Disodium or Edetate Disodium as a stabilizer.Iodipamide Meglumine Injection intended for intravascular use contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose containers,preferably of Type Ior Type IIIglass,protected from light.
Labeling— Label containers of Injection intended for intravascular injection to direct the user to discard any unused portion remaining in the container.Label containers of Injection intended for other than intravascular injection to show that the contents are not intended for intravascular injection.
Identification—
A: Dilute a volume of the Injection,if necessary,with a 0.8in 1000solution of sodium hydroxide in methanol to obtain a test solution having a concentration of 1mg per mL.The test solution responds to the Thin-layer Chromatographic Identification Test á201ñ,the Standard solution being prepared at a concentration of 1mg of USP Iodipamide RSper mLin a 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: Evaporate a volume of Injection,equivalent to about 500mg of iodipamide,to dryness,and heat the residue so obtained in a suitable crucible:violet vapors are evolved.
Bacterial endotoxins á85ñ— It contains not more than 3.6USP Endotoxin Units per mL.
pHá791ñ: between 6.5and 7.7.
Free aromatic amine— Transfer an accurately measured volume of Injection,equivalent to 1g of iodipamide meglumine,to a 50-mLvolumetric flask,dilute with water to 5mL,and add 10mLof 0.1Nsodium hydroxide.To a second 50-mLvolumetric flask add 10mLof 0.1Nsodium hydroxide,4mLof water,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 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.”
Meglumine content— Proceed as directed in the test for Meglumine contentunder Diatrizoate Meglumine Injection.The meglumine content is not less than 23.5%and not more than 26.8%of the labeled amount of iodipamide meglumine.
Other requirements— It meets the requirements of the tests for Iodine and iodideand Heavy metalsunder Diatrizoate Meglumine Injection.It meets also the requirements under Injections á1ñ.
Assay— Pipet a volume of Injection,equivalent to about 5g of iodipamide meglumine,into a 100-mLvolumetric flask,add 1.25Nsodium hydroxide to volume,and mix.Pipet 10mLof the solution into a glass-stoppered,250-mLflask,add 20mLof the sodium hydroxide solution and 500mg of powdered zinc,and proceed as directed in the Assayunder Diatrizoate Meglumine Injection,beginning with “connect the flask to a reflux condenser.”Each mLof 0.05Nsilver nitrate is equivalent to 12.75mg of C20H14I6N2O6·2C7H17NO5.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1038
Phone Number:1-301-816-8305