U.S. PHARMACOPEIA

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Povidone-Iodine Cleansing Solution
» Povidone-Iodine Cleansing Solution is a solution of Povidone-Iodine with one or more suitable surface-active agents. 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—
A: It responds to Identification tests A and B under Povidone-Iodine Topical Aerosol.
B: To 2 mL of it in a glass-stoppered test tube add 1 mL of peanut oil and 4 mL of water, and shake vigorously for 10 seconds. Allow to stand for 3 minutes: a stable emulsion is formed.
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer to a 100-mL beaker an accurately measured volume of 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.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 1780
Phone Number : 1-301-816-8394