Ipodate Sodium Capsules
» Ipodate Sodium Capsules contain not less than 90.0 percent and not more than 110.0 percent 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 2 g of ipodate sodium, to a 250-mL separator, add 100 mL of water and 50 mL of solvent hexane, and shake. Transfer the aqueous layer to a beaker, add 5 mL of 3 N hydrochloric acid, and mix. Filter (retain the filtrate), and wash the precipitate with several portions of water. Dry the precipitate in vacuum at 60
for 4 hours. A 1 in 100,000 solution of the residue so obtained, in a 1 in 100 mixture of 2 N hydrochloric acid in methanol, exhibits an UV absorbance maximum at 242 ± 2 nm.
for 4 hours. A 1 in 100,000 solution of the residue so obtained, in a 1 in 100 mixture of 2 N hydrochloric acid in methanol, exhibits an UV absorbance maximum at 242 ± 2 nm.
B:
The residue obtained in Identification test A responds to Identification test C under Ipodate Sodium.
Uniformity of dosage units 
905
:
meet the requirements.
905:
meet the requirements.
Assay—
Place a number of Capsules, equivalent to about 5 g of ipodate sodium, in a 400-mL beaker, add 200 mL of 1 N sodium hydroxide and 50 mL of solvent hexane, and stir by mechanical means until the capsules have completely disintegrated. Transfer the mixture to a 500-mL separator, wash the beaker with a total of 25 mL of 1 N sodium hydroxide in divided portions, and add the washings to the separator. Allow the layers to separate, and transfer the aqueous layer to a 500-mL volumetric flask. Wash the solvent hexane layer with two 50-mL portions of 1 N sodium hydroxide, add the washings to the volumetric flask, dilute with 1 N sodium hydroxide to volume, and mix. Pipet 25 mL of the solution, which may be milky in appearance, into a 250-mL conical flask, add 500 mg of powdered zinc, and proceed as directed in the Assay under Ipodate Sodium, beginning with “and reflux the mixture for 60 minutes.”
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Ian DeVeau, Ph.D.
Director, Veterinary Drugs and Radiopharmaceuticals 1-301-816-8178 |
(RMI05) Radiopharmaceuticals and Medical Imaging Agents 05 |
USP32–NF27 Page 2685