Potassium Iodide Tablets

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 Tablets contain NLT 94.0% and NMT 106.0% of the labeled amount of potassium iodide (KI) for Tablets of 300 mg or more, and NLT 92.5% and NMT 107.5% for Tablets of less than 300 mg.

2 IDENTIFICATION

A. IDENTIFICATION TESTS-GENERAL, Potassium (191)and lodide (191): A filtered solution of powdered Tablets meets the requirements.

3 ASSAY

PROCEDURE

Sample solution: Transfer an equivalent to 1.2 g of potassium iodide, from finely powdered Tablets (NLT 20), to a 250-mL volumetric flask. Add 100 mL of water, shake for 20 min, and dilute with water to volume. Filter through paper, discarding the first 20 mL of the filtrate.

Analysis: Transfer 100.0 mL of the filtrate, 25 mL of alcohol, and 1.0 mL of 1 N nitric acid to a 200-mL beaker. 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% of the labeled amount of potassium iodide (KI) for Tablets of 300 mg or more, and 92.5%-107.5% for Tablets of less than 300 mg

4 PERFORMANCE TESTS

4.1 DISSOLUTION (711)

For Uncoated Tablets

Medium: Water; 900 mL

Apparatus 2: 50 rpm

Time: 15 min

Detector: UV 227 nm

Standard solution: Potassium iodide in Medium

Sample solution: Sample per Dissolution (711). Dilute with Medium to a concentration that is similar to the Standard solution.

Tolerances: NLT 75% (Q) of the labeled amount of potassium iodide (KI) is dissolved.

4.2 UNIFORMITY OF DOSAGE UNITS (905)

Meet the requirements

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.