Packaging and storage— Preserve in tight, light-resistant containers.

Identification— Triturate a quantity of finely powdered Tablets, equivalent to about 1 g of iopanoic acid, with two 10-mL portions of solvent hexane, and decant and discard the liquid. Allow the residue to dry spontaneously, triturate with 15 mL of acetone, and filter. Repeat the trituration with another 15-mL portion of acetone, evaporate the combined filtrates on a steam bath to a volume of not more than 1 mL, add, with constant stirring, 20 mL of water, filter, wash the precipitate with two 5-mL portions of water, and dry at 105 for 2 hours: the iopanoic acid so obtained melts between 150 and 158, with decomposition, and responds to the Identification test under Iopanoic Acid.

Disintegration 701: 30 minutes.

Uniformity of dosage units 905: meet the requirements.

Halide ions— A portion of the powdered Tablets prepared for the Assay, equivalent to about 500 mg of iopanoic acid, meets the requirements of the test for Halide ions under Iopanoic Acid.

Residual solvents 467: meet the requirements.

Assay— Weigh and finely powder not fewer than 20 Tablets. Weigh accurately a portion of the powder, equivalent to about 1 g of iopanoic acid, and triturate with 10 mL of solvent hexane. Allow the mixture to settle, decant the hexane through a small filter, repeat the trituration with 10 mL of solvent hexane, filter through the same filter, and discard the filtrates. Warm the residue with 10 mL of neutralized alcohol at 70, filter through the same filter, and wash the undissolved residue with four 10-mL portions of neutralized alcohol at 70, passing the washings through the same filter. Cool the combined filtrate and washings to room temperature, add 3 to 5 drops of thymol blue TS, and titrate with 0.1 N sodium hydroxide VS. Each mL of 0.1 N sodium hydroxide is equivalent to 57.09 mg of C11H12I3NO2.

Expert Committee : (RMI05) Radiopharmaceuticals and Medical Imaging Agents 05

USP29–NF24 Page 1162

Phone Number : 1-301-816-8305