Povidone-Iodine Topical Aerosol
»Povidone-Iodine Topical Aerosol is a solution of Povidone-Iodine under nitrogen in a pressurized container.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 pressurized containers,and avoid exposure to excessive heat.
Identification— Spray Topical Aerosol into a beaker or flask until about 50mLhas been collected,and allow to stand for 5minutes to allow the entrapped propellant to escape.(Retain portions of the solution so obtained for the pHand Assayprocedures.)The solution meets the requirements of the following tests.
A: Add 1mLof a dilution containing about 0.05%of iodine to a mixture of 1mLof starch TSand 9mLof water:a deep blue color is produced.
B: Transfer 10mLto a 50-mLconical 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 1drop of starch TS:no blue color appears within 60seconds.
pHá791ñ— The pHof the solution prepared for the Identificationtests is not more than 6.0.
Other requirements— It meets the requirements for Pressure Test,Minimum Fill,and Leakage Testunder Aerosols,Nasal Sprays,Metered-Dose Inhalers,and Dry Powder Inhalers á601ñ.
Assay— Transfer an accurately measured volume of the solution of Topical Aerosol prepared for the Identificationtests,equivalent to about 50mg of iodine,to a 100-mLbeaker,and dilute with water to 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 iodine (I).
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1601
Phone Number:1-301-816-8394