课件案例mebendazole专着mebrofenin3772-3773MEBROFEN.pdfVIP

3772Mebendazole/OfficialMonographsUSP35

anddegas.Makeadjustmentsifnecessary(seeSystemSuitabilityIdentification,InfraredAbsorption〈197K〉.

underChromatography〈621〉).Meltingrange,ClassI〈741〉:ween185°and200°,butthe

Standardpreparation—Transferabout25mgofUSPrangweenbeginningandendofmeltingdoesnotexceed

MebendazoleRS,accuratelyweighed,toa100-mLvolumetric4°.

flask.Add10mLofformicacid,andheatinawaterbathatLossondrying〈731〉—Dryitinvacuumat100°for3hours:it

50°for15minutes.Shakebymechanicalmeansfor5minutes,losesnotmorethan0.3%ofitsweight.

add90mLofmethanol,andallowtocool.Dilutewithmetha-

Residueonignition〈281〉:notmorethan0.1%.

noltovolume,andmix.Transfer5.0mLofthissolutiontoa

25-mLvolumetricflask,dilutewithMobilephasetovolume,Heavymetals,MethodII〈231〉:0.003%.

mix,andfilterthroughafilterhavingaporosityof0.5µmorLimitofnitrilotriaceticacid—

finer.Mobilephase—Add10mLofa1in4solutionoftetrabutyl-

Assaypreparation—Weighandfinelypowdernotfewerthanammoniumhydroxideinmethanolto200mLofwater,and

20Tablets.Transferanaccuratelyweighedportionofthepow-adjustwith1MphosphoricacidtoapHof7.5±0.1.Transfer

der,equivalenttoabout500mgofmebendazole,toa