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].
Packaging and storage—
Preserve in single-dose containers, preferably of Type I glass, 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.
Identification—
A:
Dilute 3 mL of Injection with water to 100 mL, add an excess of 3 N hydrochloric acid, and filter. Wash the precipitated iothalamic acid with four 10-mL portions of water, and dry at 105
for 4 hours: the dried iothalamic acid responds to
Identification tests
A and
B under
Iothalamate Meglumine Injection.
B:
It responds to the flame test for
Sodium 
191
.
Free aromatic amine—
Dilute a suitable volume of Injection with water to yield a solution containing 100 mg of iothalamate sodium per mL. Proceed as directed in the test for
Free aromatic amine under
Iothalamic Acid, beginning with “Pipet 5 mL of this solution into a 50-mL volumetric flask.”
Iodine and iodide—
Dilute a volume of Injection, equivalent to about 2 g of iothalamate sodium, with 20 mL of water in a 50-mL beaker, add 5 mL of 2 N sulfuric acid, stir, and filter into a glass-stoppered, 50-mL cylinder. Proceed as directed for
Procedure in the test for
Iodine and iodide under
Iothalamic Acid, beginning with “To the filtrate add 5 mL of toluene.”
Heavy metals 231—
In a 50-mL color-comparison tube, mix a volume of Injection, equivalent to 1.0 g of iothalamate sodium, with 5 mL of 1 N sodium hydroxide, dilute with water to 40 mL, and mix. Using this as the
Test preparation, proceed as directed in the test for
Heavy metals under
Diatrizoate Meglumine: the limit is 0.002%.
Other requirements—
It meets the requirements under
Injections 1.
;)