头孢曲松钠欧洲药典6.0版

Semi-syntheticproductderivedfromafermentationproduct.Contentsubstance).

:96.0percentto102.0percent(anhydrousCHARACTERS

AppearanceC.(6crystallinepowder.

:almostwhiteoryellowish,slightlyhygroscopic,azabicyclo[4.2.0]oct-2-en-7-aminiumR,7R)-2-carboxy-8-oxo-3-(pyridiniomethyl)-5-thia-1-dichloride,

Solubilitymethanol,:veryfreelyslightlysolublesolubleinwater,inanhydroussparinglysolubleethanol.inIDENTIFICATION

A.Infraredabsorptionspectrophotometry(2.2.24).Comparison:ceftriaxonesodiumCRS.B.Itgivesreaction(a)ofsodium(2.3.1).

TESTS

SolutionanddiluteS.toDissolve20.0ml2.40withgtheincarbonsamesolvent.

dioxide-freewaterRAppearanceofsolution.Thesolutionisclear(2.2.1D.(6oxoethoxy]imino]-2-[2-[(triphenylmethyl)amino]thiazol-R,7R)-7-[[(Z)-2-[[2-(1,1-dimethylethoxy)-1,1-dimethyl-2-notBYmoreintenselycolouredthanreferencesolution)Yand5or4-yl]acetyl]amino]-8-oxo-3-(pyridiniomethyl)-5-thia-1-5(2.2.2).azabicyclo[4.2.0]oct-2-ene-2-carboxylate,Dilute2mlofsolutionSto20mlwithwaterR.

pH(2.2.3):6.0to8.0forsolutionS.

Specificsubstance).

opticalrotation(2.2.7):−155to−170(anhydrousDissolvesamesolvent.

0.250ginwaterRanddiluteto25.0mlwiththeRelatedsubstances.Liquidchromatography(2.2.29).Testexaminedsolutionthemobileinphase.

the.Dissolvemobile30.0phasemgandofthedilutesubstanceto100.0tomlbewithReferencesodiumCRSsolutioninthe(a)mobile.Dissolvephase30.0anddilutemgoftoceftriaxone100.0E.(62-[[2-(1,1-dimethylethoxy)-1,1-dimethyl-2-R,7R)-7-[[(Z)-2-(2-ammoniothiazol-4-yl)-themobilephase.mlwithoxoethoxy]imino]acetyl]amino]-8-oxo-3-(pyridiniomethyl)-Reference5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylatechloride,sodiumthephase.

mobileCRSsolution(b).Dissolve5.0mgofceftriaxone

phaseand5.0andmgdiluteofceftriaxoneto100.0mlimpuritywiththeAmobile

CRSinReference100.0mlwithsolutionthemobile(c).Dilutephase.1.0mlofthetestsolutiontoF.pyridine.Column:

—size:l=0.25m,Ø=4.6mm;

01/2008:0991—stationarychromatographyphase:Roctadecylsilyl(5µm).

silicagelfor

CEFTRIAXONESODIUMMobilebromidephaseRand:dissolve2.0gof2.0tetraheptylammoniumgoftetradecylammonium

bromideRCeftriaxonumnatricumabuffermixtureof440mlofwaterR,55mlof0.067Mphosphate

in

pH8005.0solutionpreparedpHby7.0dissolvingR,5.0mlofcitratebuffersolution

hydroxidemlofwaterR,adjustingto20.17pH5.0gofcitricacidRinand500mlsolutionofacetonitrileRanddilutingR.to1000.0withstrongmlwithsodiumwaterR,Flowrate:1.5ml/min.

Detection:spectrophotometerat2nm.

Injectionsolutions:(b)20andµlof(c).

thetestsolutionandreferenceCRuntime:twicetheretention[104376-79-6]

18H16N8Na2O7S3,31

/timeofceftriaxone.

2H2OMr662Systemsuitability:referencesolution(b):—resolution:DEFINITION

ceftriaxoneandminimumimpurity3.0A.betweenthepeaksduetoDisodiumyl)(methoxyimino)acetyl]amino]-3-[[(2-methyl-6-oxido-(6R,7R)-7-[[(2Z)-(2-aminothiazol-4-Limits:5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)sulphanyl]methyl]-8-oxo-5-—anyimpurity:notmorethantheareaoftheprincipalthia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate3.5hydrate.peaksolutioninthe(c)chromatogram(1.0percent);obtainedwithreferenceGeneralNotices(1)applytoallmonographsandothertexts

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CefuroximeaxetilEUROPEANPHARMACOPOEIA6.0

—totalin(4.0the:notperchromatogrammorethan4timestheareaoftheprincipalpeakcent);

obtainedwithreferencesolution(c)—disregardin(0.1theperchromatogramlimit:0.1timestheareaoftheprincipalpeakcent).

obtainedwithreferencesolution(c)N,N-Dimethylaniline(2.4.26,MethodB):maximum20ppm.

2-Ethylhexanoicacid(2.4.28):maximum0.8percentm/m.D.S-benzothiazol-2-yl(2Z)-(2-aminothiazol-4-Wateron0.100(2.5.12g.

):8.0percentto11.0percent,determined

yl)(methoxyimino)thioacetate,Bacterialintendedformsforendotoxinsuseinthe(2.6.14manufacture):lessthanof0.08IU/mg,ifremovalwithoutofbacterialafurtherendotoxins.

appropriateprocedureparenteralfordosagetheASSAY

Liquidrelatedchromatographysubstanceswith(the2.2.29following)asdescribedmodification.inthetestforInjection:testsolutionandreferencesolution(a).

E.(61,2,4-triazin-3-yl)sulphanyl]methyl]-8-oxo-5-thia-1-R,7R)-7-amino-3-[[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-Calculateazabicyclo[4.2.0]oct-2-ene-2-carboxylicacid.

thedeclaredthecontentpercentageofceftriaxonecontentofsodiumC18H16N8CRSNa2O.

7S3fromSTORAGE

Inan01/2008:1300issterile,airtightstorecontainerinasterile,protectedairtight,fromtamper-prooflight.Ifthecontainer.substancecorrected6.0

IMPURITIES

CEFUROXIMEAXETILCefuroximumaxetili

A.(6imino)acetyl]amino]-3-[[(2-methyl-5,6-dioxo-1,2,5,6-R,7R)-7-[[(2E)-(2-aminothiazol-4-yl)(methoxy-tetrahydro-1,2,4-triazin-3-yl)sulphanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylicC((E)-isomer),

acid[4-07-6]

20H22N4O10SMr510.5

DEFINITION

Mixture(6ofthe2diastereoisomersof(1RS(methoxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]-R,7R)-3-[(carbamoyloxy)methyl]-7-[[(Z)-2-(furan-2-yl)-2-)-1-(acetyloxy)ethyloct-2-ene-2-carboxylate.

Semi-syntheticproductderivedfromafermentationproduct.ContentB.(5asubstance).

:96.0percentto102.0percent(anhydrousimino)acetyl]amino]-5a,6-dihydro-3R,6R)-6-[[(2Z)-(2-aminothiazol-4-yl)(methoxy-[2,1-b]furo[3,4-d][1,3]thiazine-1,7(4HH,7)-dione,

H-azeto-CHARACTERS

Appearance:whiteoralmostwhitepowder.

Solubilityethyl:slightlysolubleinwater,solubleinacetone,in(96peracetatecent).

andinmethanol,slightlysolubleinethanolIDENTIFICATION

A.Infraredabsorptionspectrophotometry(2.2.24).Comparison:cefuroximeaxetilCRS.

C.2-methyl-3-sulphanyl-1,2-dihydro-1,2,4-triazine-5,6-dione,B.Examinethechromatogramsobtainedintheassay.

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