Povidone-Iodine Topical Aerosol
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
>> Povidone-lodine Topical Aerosol is a solution of Povidone-lodine under nitrogen in a pressurized container. It contains not less than 85.0 percent and not more than 120.0 percent of the labeled amount of iodine (I).
1 Packaging and storage
Preserve in pressurized containers, and avoid exposure to excessive heat.
2 Identification
Spray Topical Aerosol into a beaker or flask until about 50 mL has been collected, and allow to stand for 5 minutes to allow the entrapped propellant to escape. (Retain portions of the solution so obtained for the pH and Assay procedures.) The solution meets the requirements of the following tests.
A: Add 1 mL of a dilution containing about 0.05% of iodine to a mixture of 1 mL of starch TS and 9 mL of water: a deep blue color is produced.
B: Transfer 10 mL to a 50-mL conical flask, avoiding contact with the neck of the flask. Cover the mouth of the flask with a small disk of filter paper, and wet it with 1 drop of starch TS: no blue color appears within 60 seconds.
3 pH (791)
The pH of the solution prepared for the Identification tests is not more than 6.0.
4 Other requirements
It meets the requirements for Topical Aerosols (603).
5 Assay
Transfer an accurately measured volume of the solution of Topical Aerosol prepared for the Identification tests, equivalent to about 50 mg of iodine, to a 100-mL beaker, and dilute with water to a total volume of not less than 30 mL. Titrate immediately with 0.02 N sodium thiosulfate VS, determining the endpoint potentiometrically, using a platinum-calomel electrode system. Perform a blank determination, and make any necessary correction. Each mL of 0.02 N sodium thiosulfate is equivalent to 2.538 mg of iodine (I).
