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

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

Disintegration á701ñ: 30minutes.

Uniformity of dosage units á905ñ: meet the requirements.

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

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

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 1048

Phone Number:1-301-816-8305