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.
noteIf 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. Products that have data to demonstrate acceptable stability without the addition of thiosulfate are exempt from this requirement. 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.
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.
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.
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USP32NF27 Page 3349Pharmacopeial Forum: Volume No. 31(3) Page 786