Povidone-Iodine
;)
2-Pyrrolidinone,1-ethenyl-,homopolymer,compd.with iodine.
1-Vinyl-2-pyrrolidinone polymer,compound with iodine [25655-41-8].
»Povidone-Iodine is a complex of Iodine with Povidone.It contains not less than 9.0percent and not more than 12.0percent of available iodine (I),calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Identification—
A:
Add 1drop of a solution (1in 10)to a mixture of 1mLof starch TSand 9mLof water:a deep blue color is produced.
B:
Spread 1mLof a solution (1in 10)over an area of about 20cm ×20cm on a glass plate,and allow to air-dry at room temperature in an atmosphere of low humidity overnight:a brown,dry,non-smearing film is formed,and it dissolves readily in water.
Loss on drying á731ñ—
Dry 5.0g of it at 105
until the difference between two successive weighings at 1-hour intervals is not greater than 5.0mg:it loses not more than 8.0%of its weight.
until the difference between two successive weighings at 1-hour intervals is not greater than 5.0mg:it loses not more than 8.0%of its weight.
Residue on ignition á281ñ:
not more than 0.025%,from 2g.
Iodide ion—
Determination of total iodine—
Dissolve about 500mg of Povidone-Iodine,accurately weighed,in 100mLof water in a 250-mLconical flask.Add sodium bisulfite TSuntil the color of iodine has disappeared.Add 25.0mLof 0.1Nsilver nitrate VSand 10mLof nitric acid,and mix.Titrate the excess silver nitrate with 0.1Nammonium thiocyanate VS,using ferric ammonium sulfate TSas the indicator.Perform a blank determination (see Residual Titrationsunder Titrimetry á541ñ).Each mLof 0.1Nsilver nitrate is equivalent to 12.69mg of I.From the percentage of total iodine,calculated on the dried basis,subtract the percentage of available iodine (see Assay for available iodine),to obtain the percentage of iodide ion.Not more than 6.6%,calculated on the dried basis,is found.
Heavy metals,Method IIá231ñ:
0.002%.
Nitrogen content á461ñ—
Not less than 9.5%and not more than 11.5%of Nis found,calculated on the dried basis.
Assay for available iodine—
Place about 5g of Povidone-Iodine,accurately weighed,in a 400-mLbeaker,and add 200mLof water.Cover the beaker,and stir by mechanical means at room temperature for not more than 1hour to dissolve as completely as possible.Titrate immediately with 0.1Nsodium thiosulfate VS,adding 3mLof starch TSas the endpoint is approached.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsodium thiosulfate is equivalent to 12.69mg of I.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1601
Pharmacopeial Forum:Volume No.29(5)Page 1564
Phone Number:1-301-816-8394