Povidone-Iodine Topical Solution
If you find any inaccurate information, please let us know by providing your feedback here
This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Povidone-lodine Topical Solution is a solution of Povidone-lodine. It contains NLT 85.0% and NMT 120.0% of the labeled amount of iodine (I). It may contain a small amount of alcohol.
2 IDENTIFICATION
A.
Sample solution 1: Dilution containing 0.05% of iodine
Analysis 1: Add 1 mL of Sample solution 1 to a mixture of 1 mL of starch TS and 9 mL of water.
Acceptance criteria 1: A deep blue color is produced.
Sample solution 2: 10 mL
Analysis 2: Transfer Sample solution 2 to a 50-mL conical flask, avoiding contact with the neck of the flask. Cover the mouth of the flask with a small disk of filter paper, and wet it with 1 drop of starch TS.
Acceptance criteria 2: No blue color appears within 60 s.
3 ASSAY
PROCEDURE
Sample solution: Nominally 50 mg of iodine from an accurately measured volume of Topical Solution
Titrimetric system
Mode: Direct titration
Titrant: 0.02 N sodium thiosulfate VS
Endpoint detection: Potentiometric
Analysis: Transfer the Sample solution to a 100-mL beaker, and add water to make a total volume of NLT 30 mL. Titrate immediately with Titrant to the endpoint, 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 iodine.
Acceptance criteria: 85.0%-120.0% of the labeled amount of iodine
4 OTHER COMPONENTS
ALCOHOL DETERMINATION (611)(if present): 90.0%-110.0% of the labeled amount of alcohol (C2H5OH)
5 SPECIFIC TESTS
pH (791): 1.5-6.5
6 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight containers.
