Packaging and storage— Preserve in well-filled,light-resistant,single-dose or multiple-dose containers.

Identification— Place 1drop in a test tube,and heat directly in a flame:the violet color of iodine vapors is observed.

Specific gravity á841ñ: between 1.280and 1.293,at 15.

Viscosity á911ñ: between 50centipoises and 100centipoises,at 15.

Sterility á71ñ: meets the requirements.

Acidity— Dissolve 1.0mLin 10mLof chloroform in a glass-stoppered cylinder,add phenolphthalein TSand 0.30mLof sodium hydroxide solution (1in 250),insert the stopper,and shake vigorously:a red color is produced.

Free iodine— Dissolve 1.0mLin 5mLof chloroform,add 20mLof potassium iodide solution (1in 20),agitate vigorously,and add 2drops of starch TS:no blue color is produced.

Assay— [Caution—Observe rigorously the precautions set forth for Procedure under Oxygen Flask Combustion á471ñ. ]Weigh accurately about 30mg (1drop)of Injection in a tared cellulose acetate capsule,and proceed as directed for Procedureunder Oxygen Flask Combustion á471ñ,beginning with “Place the specimen,”and using a thick-walled,500-mLcombustion flask.Use 10mLof sodium hydroxide solution (1in 100)and 1mLof freshly prepared sodium bisulfite solution (1in 100)as the absorbing liquid.Pipet 1mLof bromine-sodium acetate TSinto the cup of the flask,loosen the stopper,and allow the solution to be sucked into the flask.Wash down the cup and the ground joint with water,insert the stopper in the flask,shake it vigorously,then add 5drops of formic acid,and again shake the flask.Remove the stopper,and rinse the stopper and the specimen holder with water,collecting the rinsings in the flask.Bubble nitrogen through the solution to displace all of the oxygen from the solution and the flask.Add 0.50g of potassium iodide and 3mLof 2Nsulfuric acid,allow the mixture to stand for 2minutes,add 3mLof starch TS,and titrate the liberated iodine with 0.05Nsodium thiosulfate VS.Each mLof 0.05Nsodium thiosulfate is equivalent to 1.058mg of iodine (I).

Expert Committee:(RMI)Radiopharmaceuticals and Medical Imaging Agents

USP28–NF23Page 790

Phone Number:1-301-816-8305