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.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials

USP29–NF24 Page 1780

Phone Number : 1-301-816-8394