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Povidone-Iodine Ointment
»Povidone-Iodine Ointment is an emulsion,solution,or suspension of Povidone-Iodine in a suitable water-soluble ointment base.It contains not less than 85.0percent and not more than 120.0percent of the labeled amount of iodine (I).
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Add 1mLof an alcohol dilution of it containing about 0.05%of iodine to a mixture of 1mLof starch TSand 9mLof water:a deep blue color is produced.
B:
Place 10g in a 50-mLbeaker,avoiding contact with the walls of the beaker.Cover the mouth of the beaker with a disk of filter paper,and wet it with 1drop of starch TS:no blue color appears within 60seconds.
Minimum fill á755ñ:
meets the requirements.
pHá791ñ:
between 1.5and 6.5,determined in a solution (1in 20).
Assay—
Transfer an accurately weighed quantity of Ointment,equivalent to about 50mg of iodine,to a 100-mLbeaker,add water to make a total volume of not less than 30mL,and stir until the ointment is dissolved.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
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