U.S. PHARMACOPEIA

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Potassium Iodide
KI 166.00

Potassium iodide.
Potassium iodide [7681-11-0].
» Potassium Iodide contains not less than 99.0 percent and not more than 101.5 percent of KI, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Identification— A solution of it meets the requirements of the tests for Potassium 191 and for Iodide 191.
Alkalinity— Dissolve 1.0 g in 10 mL of water, and add 0.1 mL of 0.1 N sulfuric acid and 1 drop of phenolphthalein TS: no color is produced.
Loss on drying 731 Dry it at 105 for 4 hours: it loses not more than 1.0% of its weight.
Iodate— Dissolve 1.1 g in sufficient ammonia- and carbon dioxide-free water to obtain 10 mL of solution, and transfer to a color-comparison tube. Add 1 mL of starch TS and 0.25 mL of 1.0 N sulfuric acid, mix, and compare the color with that of a control containing, in a similar volume, 100 mg of Potassium Iodide, 1 mL of standard iodate solution [prepare by diluting 1 mL of potassium iodate solution (1 in 2500) with water to 100 mL], 1 mL of starch TS, and 0.25 mL of 1.0 N sulfuric acid. Any color produced in the solution of the test specimen does not exceed that in the control: not more than 4 µg per g is found.
Limit of nitrate, nitrite, and ammonia— To a solution of 1 g in 5 mL of water contained in a test tube of about 40-mL capacity add 5 mL of 1 N sodium hydroxide and about 200 mg of aluminum wire. Insert a pledget of purified cotton in the upper portion of the test tube, and place a piece of moistened red litmus paper over the mouth of the tube. Heat the test tube and its contents in a steam bath for 15 minutes: no blue coloration of the paper is discernible.
Thiosulfate and barium— Dissolve 0.5 g in 10 mL of ammonia- and carbon dioxide-free water, and add 2 drops of 2 N sulfuric acid: no turbidity develops within 1 minute.
Heavy metals 231 Dissolve 2.0 g in 25 mL of water: the limit is 0.001%.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 500 mg of Potassium Iodide, accurately weighed, in about 10 mL of water, and add 35 mL of hydrochloric acid. Titrate with 0.05 M potassium iodate VS until the dark brown solution which is produced becomes pale brown. Add 2 to 3 drops of amaranth TS, and continue the titration slowly until the red color just changes to yellow. Each mL of 0.05 M potassium iodate is equivalent to 16.60 mg of KI.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 1772
Phone Number : 1-301-816-8394