Povidone-Iodine Topical Aerosol
» Povidone-Iodine Topical Aerosol is a solution of Povidone-Iodine 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).
Packaging and storage— Preserve in pressurized containers, and avoid exposure to excessive heat.
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.
pH 791 The pH of the solution prepared for the Identification tests is not more than 6.0.
Other requirements— It meets the requirements for Pressure Test, Minimum Fill, and Leakage Test under Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers 601.
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).
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Topic/Question Contact Expert Committee
Monograph Behnam Davani, Ph.D., M.B.A.
Senior Scientist
(MDAA05) Monograph Development-Antivirals and Antimicrobials
USP32–NF27 Page 3355