专着炸甲烷bumetanide injection2397-弹酰胺注射.pdfVIP

USP35OfficialMonographs/Bumetanide2397

USPButyl3-(butylamino)-4-phenoxy-5-sulfamoylbenzoateRSAssay—Dissolveabout1gofBumetanide,accuratelyweighed,

CHNOS420.53in150mLofalcoholina250-mLconicalflask.Addphenolred

212825

Identification—TS,andtitratewith0.1NsodiumhydroxideVS.Performa

A:InfraredAbsorption〈197M〉.blankdetermination(seeTitrimetry〈541〉),andmakeanyneces-

sarycorrection.EachmLof0.1Nsodiumhydroxideisequiva-

B:UltravioletAbsorption〈197U〉—lentto36.44mgofCHNOS.

172025

Solution:50µgpermL.

Medium:isopropylalcohol.

C:Theprincipalspotobtainedfromthechromatogramof

theTestpreparationexhibitsanRvaluecorrespondingtothat

FBumetanideInjection

inthechromatogramofStandardsolution1,asobtainedinthe

testforRelatedcompounds.

Lossondrying〈731〉—Dryitat105°for4hours:itlosesnot»BumetanideInjectionisasterilesolutionof

morethan0.5%ofitsweight.BumetanideinWaterforInjection,preparedwith

Residueonignition〈281〉:notmorethan0.1%,a1-gspeci-theaidofSodiumHydroxide.Itcontainsnot