Potassium Iodide Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Potassium lodide Oral Solution contains NLT 94.0% and NMT 106.0% of the labeled amount of potassium iodide (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. 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 lodide Oral Solution under normal conditions of storage, especially if refrigerated.]

2 IDENTIFICATION

A. IDENTIFICATION TESTS-GENERAL, Potassium (191) and lodide(191): Meets the requirements

3 ASSAY

PROCEDURE

Sample solution: 50 mg/mL of potassium iodide from Oral Solution in water

Analysis: Transfer 10.0 mL of the Sample solution to a 150-mL beaker, and add 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, using a silver indicator electrode and an appropriate reference electrode. Perform a blank determination (see Titrimetry (541)). Each mL of 0.1 N silver nitrate is equivalent to 16.60 mg of KI.

Acceptance criteria: 94.0%-106.0%

4 PERFORMANCE TESTS

4.1 UNIFORMITY OF DOSAGE UNITS (905)

For Oral Solution packaged in single-unit containers: Meets the requirements

4.2 DELIVERABLE VOLUME (698)

For Oral Solution packaged in multiple-unit containers: Meets the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.