USP Monographs: Potassium Iodide Oral Solution

Potassium Iodide Oral Solution

» Potassium Iodide Oral Solution contains, not less than 94.0 percent and not more than 106.0 percent of the labeled amount of KI.

NOTE—If Potassium Iodide Oral Solution is not to be used within a short time, add 0.5 mg of sodium thiosulfate for each g of KI. Crystals of potassium iodide may form in Potassium Iodide Oral Solution under normal conditions of storage, especially if refrigerated.

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

Identification— It responds to the tests for Potassium

191

and for Iodide

191

Uniformity of dosage units

905

—

FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume

698

—

FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay— Dilute an accurately measured volume of Oral Solution with water to obtain a solution containing about 50 mg of potassium iodide per mL. To 10.0 mL of this solution, in a 150-mL beaker, add about 40 mL of water, 25 mL of alcohol, and 1.0 mL of 1 N nitric acid. Titrate with 0.1 N silver nitrate VS, determining the endpoint potentiometrically, using silver-calomel electrodes and a salt bridge containing 4 percent agar in a saturated potassium nitrate solution. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N silver nitrate 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

Pharmacopeial Forum : Volume No. 31(3) Page 786

Phone Number : 1-301-816-8394


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