Povidone-Iodine Topical Solution
» Povidone-Iodine Topical Solution is a solution of Povidone-Iodine. It contains not less than 85.0 percent and not more than 120.0 percent of the labeled amount of iodine (I). It may contain a small amount of alcohol.
Packaging and storage— Preserve in tight containers.
Identification— It responds to Identification tests A and B under Povidone-Iodine Topical Aerosol.
pH 791: between 1.5 and 6.5.
Alcohol content (if present) 611: between 90.0% and 110.0% of the labeled amount of C2H5OH.
Assay— Transfer to a 100-mL beaker an accurately measured volume of Topical Solution, equivalent to about 50 mg of iodine, and add water to make 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 I.
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Topic/Question Contact Expert Committee
Monograph Leonel M. Santos, Ph.D.
Senior Scientific Liaison
(SM12010) Monographs - Small Molecules 1
USP35–NF30 Page 4382