Povidone-Iodine Topical Solution
»Povidone-Iodine Topical Solution is a solution of Povidone-Iodine.It contains not less than 85.0percent and not more than 120.0percent 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 Identificationtests Aand Bunder Povidone-Iodine Topical Aerosol.
pHá791ñ: between 1.5and 6.5.
Alcohol content (if present)á611ñ: between 90.0%and 110.0%of the labeled amount of C2H5OH.
Assay— Transfer to a 100-mLbeaker an accurately measured volume of Topical Solution,equivalent to about 50mg of iodine,and add water to make a total volume of not less than 30mL.Titrate immediately with 0.02Nsodium thiosulfate VS,determining the endpoint potentiometrically,using a platinum-calomel electrode system.Perform a blank determination,and make any necessary correction.Each mLof 0.02Nsodium thiosulfate is equivalent to 2.538mg of I.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1602
Phone Number:1-301-816-8394