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 85.0 percent and not more than 120.0 percent of the labeled amount of iodine (I).
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Add 1 mL of an alcohol dilution of it containing about 0.05% of iodine to a mixture of 1 mL of starch TS and 9 mL of water: a deep blue color is produced.
B:
Place 10 g in a 50-mL beaker, avoiding contact with the walls of the beaker. Cover the mouth of the beaker with a disk of filter paper, and wet it with 1 drop of starch TS: no blue color appears within 60 seconds.
Minimum fill 
755
:
meets the requirements.
755:
meets the requirements.
pH 791:
between 1.5 and 6.5, determined in a solution (1 in 20).
791:
between 1.5 and 6.5, determined in a solution (1 in 20).
Assay—
Transfer an accurately weighed quantity of Ointment, equivalent to about 50 mg of iodine, to a 100-mL beaker, add water to make a total volume of not less than 30 mL, and stir until the ointment is dissolved. 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—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
USP35–NF30 Page 4382