Ipodate Sodium Capsules
»Ipodate Sodium Capsules contain not less than 90.0percent and not more than 110.0percent of the labeled amount of C12H12I3N2NaO2.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Transfer a portion of the contents of Capsules,equivalent to about 2g of ipodate sodium,to a 250-mLseparator,add 100mLof water and 50mLof solvent hexane,and shake.Transfer the aqueous layer to a beaker,add 5mLof 3Nhydrochloric acid,and mix.Filter (retain the filtrate),and wash the precipitate with several portions of water.Dry the precipitate in vacuum at 60
for 4hours.A1in 100,000solution of the residue so obtained,in a 1in 100mixture of 2Nhydrochloric acid in methanol,exhibits an UVabsorbance maximum at 242±2nm.
for 4hours.A1in 100,000solution of the residue so obtained,in a 1in 100mixture of 2Nhydrochloric acid in methanol,exhibits an UVabsorbance maximum at 242±2nm.
B:
The residue obtained in Identificationtest Aresponds to Identificationtest Cunder Ipodate Sodium.
Uniformity of dosage units á905ñ:
meet the requirements.
Assay—
Place a number of Capsules,equivalent to about 5g of ipodate sodium,in a 400-mLbeaker,add 200mLof 1Nsodium hydroxide and 50mLof solvent hexane,and stir by mechanical means until the capsules have completely disintegrated.Transfer the mixture to a 500-mLseparator,wash the beaker with a total of 25mLof 1Nsodium hydroxide in divided portions,and add the washings to the separator.Allow the layers to separate,and transfer the aqueous layer to a 500-mLvolumetric flask.Wash the solvent hexane layer with two 50-mLportions of 1Nsodium hydroxide,add the washings to the volumetric flask,dilute with 1Nsodium hydroxide to volume,and mix.Pipet 25mLof the solution,which may be milky in appearance,into a 250-mLconical flask,add 500mg of powdered zinc,and proceed as directed in the Assayunder Ipodate Sodium,beginning with “and reflux the mixture for 60minutes.”
Auxiliary Information—
Staff Liaison:Andrzej Wilk,Ph.D.,Senior Scientific Associate
Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents
USP28–NF23Page 1062
Phone Number:1-301-816-8305