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  • Povidone Iodine USP

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    Jansen B. Lauren
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    Povidone-Iodine is a complex of iodine and povidone that contains between 9-12% available iodine. It must be stored in tight containers and forms a brown, dry film when dried. Tests are performed to determine levels of iodide ion, nitrogen content, heavy metals, and available iodine to ensure it meets standards.

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    Povidone-Iodine is a complex of iodine and povidone that contains between 9-12% available iodine. It must be stored in tight containers and forms a brown, dry film when dried. Tests are performed to determine levels of iodide ion, nitrogen content, heavy metals, and available iodine to ensure it meets standards.

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    88 visualizzazioni2 pagine

    Povidone Iodine USP

    Caricato da

    Jansen B. Lauren
    Povidone-Iodine is a complex of iodine and povidone that contains between 9-12% available iodine. It must be stored in tight containers and forms a brown, dry film when dried. Tests are performed to determine levels of iodide ion, nitrogen content, heavy metals, and available iodine to ensure it meets standards.

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    Povidone-Iodine

    Povidone-Iodine

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    (C6H9NO) xI 2-Pyrrolidinone,1-ethenyl-,homopolymer,compd.withiodine. 1-Vinyl-2-pyrrolidinonepolymer,compoundwithiodine [25655-41-8].


    n

    Povidone-IodineisacomplexofIodinewithPovidone.Itcontainsnotless than9.0percentandnotmorethan12.0percentofavailableiodine(I), calculatedonthedriedbasis.


    Packaging and storagePreserveintightcontainers. Identification A: Add1dropofasolution(1in10)toamixtureof1mLofstarchTSand9mLofwater:adeep bluecolorisproduced. B: Spread1mLofasolution(1in10)overanareaofabout20cm20cmonaglassplate,and allowtoair-dryatroomtemperatureinanatmosphereoflowhumidityovernight:abrown,dry,nonsmearingfilmisformed,anditdissolvesreadilyinwater. Loss on drying 731 Dry5.0gofitat105 untilthedifferencebetweentwosuccessive weighingsat1-hourintervalsisnotgreaterthan5.0mg:itlosesnotmorethan8.0%ofitsweight. Residue on ignition Iodide ion Determination of total iodineDissolveabout500mgofPovidone-Iodine,accuratelyweighed,in 100mLofwaterina250-mLconicalflask.AddsodiumbisulfiteTSuntilthecolorofiodinehas disappeared.Add25.0mLof0.1NsilvernitrateVSand10mLofnitricacid,andmix.Titratethe excesssilvernitratewith0.1NammoniumthiocyanateVS,usingferricammoniumsulfateTSas theindicator.Performablankdetermination(see Residual TitrationsunderTitrimetry 541 ). 281 : notmorethan0.025%,from2g.

    EachmLof0.1Nsilvernitrateisequivalentto12.69mgofI.Fromthepercentageoftotaliodine, calculatedonthedriedbasis,subtractthepercentageofavailableiodine(see Assay for available iodine),toobtainthepercentageofiodideion.Notmorethan6.6%,calculatedonthedriedbasis, isfound. Heavy metals, Method II 231 : 0.002%.

    Nitrogen content 461 Notlessthan9.5%andnotmorethan11.5%ofNisfound, calculatedonthedriedbasis. Assay for available iodinePlaceabout5gofPovidone-Iodine,accuratelyweighed,ina400mLbeaker,andadd200mLofwater.Coverthebeaker,andstirbymechanicalmeansatroom temperaturefornotmorethan1hourtodissolveascompletelyaspossible.Titrateimmediately with0.1NsodiumthiosulfateVS,adding3mLofstarchTSastheendpointisapproached. Performablankdetermination,andmakeanynecessarycorrection.EachmLof0.1Nsodium thiosulfateisequivalentto12.69mgofI. Auxiliary InformationStaff Liaison:BehnamDavani,Ph.D.,MBA,SeniorScientist Expert Committee:(MDAA05)MonographDevelopment-AntiviralsandAntimicrobials USP30NF25Page2995 Pharmacopeial Forum:VolumeNo.29(5)Page1564 Phone Number:1-301-816-8394

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