Iothalamate Meglumine Injection
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C11H9I3N2O4·C7H17NO5 809.13

Benzoic acid,3-(acetylamino)-2,4,6-triiodo-5-[(methylamino)carbonyl]-,compd.with 1-deoxy-1-(methylamino)-D-glucitol (1:1).
1-Deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt) [13087-53-1].
»Iothalamate Meglumine Injection is a sterile solution of Iothalamic Acid 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 iothalamate meglumine (C11H9I3N2O4·C7H17NO5).It may contain small amounts of suitable buffers and of Edetate Calcium Disodium or Edetate Disodium as a stabilizer.Iothalamate Meglumine Injection intended for intravascular use contains no antimicrobial agents.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass,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— Dilute 3mLof Injection with water to 100mL,add an excess of 3Nhydrochloric acid,and filter.Wash the precipitated iothalamic acid on the filter with four 10-mLportions of water,and dry at 105for 4hours:the dried iothalamic acid responds to the following tests.
A: The IRabsorption spectrum of a 0.5%potassium bromide dispersion of the dried acid exhibits maxima only at the same wavelengths as that of a similar preparation of USP Iothalamic Acid RS.
B: Heat about 500mg of the dried acid in a suitable crucible:violet vapors are evolved.
Bacterial endotoxins á85ñ— It contains not more than 0.9USP Endotoxin Unit per mL.
pHá791ñ: between 6.5and 7.7.
Free aromatic amine— Dilute a suitable volume of Injection with water to yield a solution containing 100mg of iothalamate meglumine per mL.Proceed as directed in the test for Free aromatic amineunder Iothalamic Acid,beginning with “Pipet 5mLof this solution into a 50-mLvolumetric flask.”
Iodine and iodide— Dilute a volume of Injection,equivalent to 2g of iothalamate meglumine,with 20mLof water in a 50-mLbeaker,add 5mLof 2Nsulfuric acid,stir,and filter into a glass-stoppered,50-mLcylinder.Proceed as directed for Procedurein the test for Iodine and iodideunder Iothalamic Acid,beginning with “To the filtrate add 5mLof toluene.”
Heavy metals á231ñ— In a 50-mLcolor-comparison tube,mix a volume of Injection,equivalent to 1.0g of iothalamate meglumine,with 5mLof 1Nsodium hydroxide,dilute with water to 40mL,and mix.Using this as the Test preparation,proceed as directed in the test for Heavy metalsunder Diatrizoate Meglumine:the limit is 0.002%.
Meglumine content— Proceed as directed in the test for Meglumine contentunder Diatrizoate Meglumine Injection.The meglumine content is not less than 22.9%and not more than 25.3%of the labeled amount of iothalamate meglumine.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Pipet a volume of Injection,equivalent to about 4g of iothalamate meglumine,into a 250-mLvolumetric flask,dilute with water to volume,and mix.Pipet 25mLof this solution into a glass-stoppered,125-mLconical flask,add 12mLof 5Nsodium hydroxide and 1g of powdered zinc,connect the flask to a reflux condenser,and reflux for 30minutes.Cool 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 40mLof 2Nsulfuric acid,and titrate immediately with 0.05Nsilver nitrate VS,determining the endpoint potentiometrically,using silver-calomel electrodes and an agar-potassium nitrate salt bridge.Each mLof 0.05Nsilver nitrate is equivalent to 13.49mg of C11H9I3N2O4·C7H17NO5.
Auxiliary Information— Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1051
Phone Number:1-301-816-8305