Ipodate Sodium
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Benzenepropanoic acid,3-[[(dimethylamino)methylene]amino]-2,4,6-triiodo-,sodium salt.
Sodium 3-[[(dimethylamino)methylene]amino]-2,4,6-triiodohydrocinnamate [1221-56-3].
»Ipodate Sodium contains not less than 97.5percent and not more than 102.5percent of C12H12I3N2NaO2,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
methanol.
Absorptivities at 235nm,calculated on the dried basis,do not differ by more than 3.0%.
C:
Heat about 500mg in a porcelain crucible over a free flame:violet vapors of iodine are evolved.
D:
It responds to the flame test for Sodium á191ñ.
Loss on drying á731ñ—
Dry it in vacuum at 60
for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Iodide or iodine—
Dissolve about 200mg in 10mLof 6Nacetic acid,add 2mLof 1Nsulfuric acid and 15mLof chloroform,and shake vigorously.Allow the layers to separate:the chloroform layer shows not more than a faint violet color.Add 1mLof 0.1Npotassium iodate,shake vigorously,and allow the layers to separate:the chloroform layer shows at most a slight trace of violet color.
Heavy metals,Method IIá231ñ:
0.003%.
Assay—
Transfer about 300mg of Ipodate Sodium,accurately weighed,to a 250-mLflask,add 30mLof 1.25Nsodium hydroxide and 0.5g of powdered zinc,and reflux the mixture for 60minutes.Cool,wash the condenser with 20mLof water,and filter the mixture.Wash the flask and the filter with small portions of water,adding the washings to the filtrate.Add to the filtrate 5mLof glacial acetic acid and 3mLof a mixture of 2drops of nitric acid in 5mLof water,then add 3drops of eosin Y TS,and titrate with 0.05Nsilver nitrate VSuntil the entire mixture changes to a permanent pink color.Each mLof 0.05Nsilver nitrate is equivalent to 10.33mg of C12H12I3N2NaO2.
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1061
Phone Number:1-301-816-8305