Iothalamate Sodium Injection
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Benzoic acid,3-(acetylamino)-2,4,6-triiodo-5-[(methylamino)carbonyl]-,monosodium salt.
Monosodium 5-acetamido-2,4,6-triiodo-N-methylisophthalamate [1225-20-3].
»Iothalamate Sodium Injection is a sterile solution of Iothalamic Acid in Water for Injection prepared with the aid of Sodium Hydroxide.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of iothalamate sodium (C11H8I3N2NaO4).It may contain small amounts of suitable buffers and of Edetate Calcium Disodium or Edetate Disodium as a stabilizer.Iothalamate Sodium 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 the Injection intended for intravascular injection to direct the user to discard any unused portion remaining in the container.Label containers of the Injection intended for other than intravascular injection to show that the contents are not intended for intravascular injection.
USP Reference standards á11ñ—
USP5-Amino-2,4,6-triiodo-N-methylisophthalamic Acid RS.USP Endotoxin RS.USP Iothalamic Acid RS.
Identification—
A:
Dilute 3mLof Injection with water to 100mL,add an excess of 3Nhydrochloric acid,and filter.Wash the precipitated iothalamic acid with four 10-mLportions of water,and dry at 105
for 4hours:the dried iothalamic acid responds to Identificationtests Aand Bunder Iothalamate Meglumine Injection.
for 4hours:the dried iothalamic acid responds to Identificationtests Aand Bunder Iothalamate Meglumine Injection.
B:
It responds to the flame test for Sodium á191ñ.
Bacterial endotoxins á85ñ—
It contains not more than 3.35USP Endotoxin Units 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 sodium 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 about 2g of iothalamate sodium,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 sodium,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%.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Proceed with Injection as directed in the Assayunder Iothalamate Meglumine Injection.Each mLof 30.05Nsilver nitrate is equivalent to 10.60mg of C11H8I3N2NaO4.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1052
Phone Number:1-301-816-8305