Povidone-Iodine Ointment
If you find any inaccurate information, please let us know by providing your feedback here
Tóm tắt nội dung
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 Ointment is an emulsion, solution, or suspension of Povidone-lodine in a suitable water-soluble ointment base. It contains NLT 85.0% and NMT 120.0% of the labeled amount of iodine (I).
2 IDENTIFICATION
A.
Sample solution: Alcohol dilution containing 0.05% of iodine
Analysis: Add 1 mL of the Sample solution to a mixture of 1 mL of starch TS and 9 mL of water.
Acceptance criteria: A deep blue color is produced.
B.
Sample: 10 g
Analysis: Place the Sample 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.
Acceptance criteria: No blue color appears within 60 s.
3 ASSAY
PROCEDURE
Sample: Nominally 50 mg of iodine from an accurately weighed quantity of Ointment
Titrimetric system
Mode: Direct titration
Titrant: 0.02 N sodium thiosulfate VS
Endpoint detection: Potentiometric
Analysis: Transfer the Sample to a 100-mL beaker, add water to make a total volume of NLT 30 mL, and stir until the Ointment is dissolved. 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 PERFORMANCE TESTS
MINIMUM FILL (755): Meets the requirements
5 SPECIFIC TESTS
PH (791)
Sample solution: 50 mg/mL
Acceptance criteria: 1.5-6.5
6 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight containers.
