药典盐酸卡因对照美他尼药大生药学0541e.pdfVIP

EUROPEANPHARMACOPOEIA7.0Bupivacainehydrochloride

Comparison:bumetanideCRS.STORAGE

Ifthespectraobtainedinthesolidstateshowdifferences,Protectedfromlight.

dissolvethesubstancetobeexaminedandthereference

substanceseparatelyinacetoneR,evaporatetodrynessandIMPURITIES

recordnewspectrausingtheresidues.Specifiedimpurities:A,B,C,D.

TESTS

Appearanceofsolution.Thesolutionisclear(2.2.1)and

colourless(2.2.2,MethodII).

Dissolve0.1gina6g/LsolutionofpotassiumhydroxideR

anddiluteto20mLwiththesamesolution.

Relatedsubstances.Liquidchromatography(2.2.29).

Testsolution.Dissolve50mgofthesubstancetobeexaminedA.R1=H,R2=NO:3-nitro-4-phenoxy-5-sulfamoylbenzoicacid,

inthemobilephaseanddiluteto25.0mLwiththemobilephase.2

Referencesolution(a).Dilute1.0mLofthetestsolutiontoB.R1=H,R2=NH2:3-amino-4-phenoxy-5-sulfamoylbenzoic

acid,

100.0mLwiththemobilephase.Dilute1.0mLofthissolution

to10.0mLwiththemobilephase.C.R1=CH,R2=NH-CH:butyl3-(butylamino)-4-phenoxy-

4949

Referencesolution(b).Dissolve2mgofbumetanide5-sulfamoylbenzoate,

impurityACRSand2mgofbumetanideimpurityBCRSin

themobilephaseanddiluteto10.0mLwiththemobilephase.

Dilute1.0mLofthissolutionto100.0mLwiththemobile

phase.

Column:

—size:l=0.15m,Ø=4.6mm,

—stationaryphase:end-