EP7.0--盐酸莫西沙星
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EUROPEANPHARMACOPOEIA7.0Moxifloxacin
hydrochloride
K.R=H,R′=CO-C6H4-pNO2:5-O
-(4-nitrobenzoyl)moxidectin,
E.(4S
)-2-dehydro-4-hydromoxidectin,
L.(23Z)-moxidectin.
01/2008:2254corrected6.2
MOXIFLOXACINHYDROCHLORIDE
Moxifloxacini
hydrochloridum
G.(23E,25S)-5O-desmethyl-28-deoxy-25-[(1E)-1,3-dimethylbut-1-enyl]-23-(methoxyimino)milbemycin
B,
C21H25ClFN3O4
Mr437.9
DEFINITION
1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4a6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-S,7aS)-octahydro-carboxylicacidhydrochloride.
Content:98.0percentto102.0percent(anhydroussubstance).PRODUCTION
TheH.
2,5-didehydro-5-deoxymoxidectin,
satisfactoryproductionenantiomericmethodispurityvalidatedofthetofinaldemonstrateproduct.
theCHARACTERS
Appearancehygroscopic.
:lightyelloworyellowpowderorcrystals,slightlySolubility(96percent),:sparinglypracticallysolubleinsolubleinwater,inacetone.
slightlysolubleinethanolIDENTIFICATION
A.Specificopticalrotation(seeTests).
B.Infraredabsorptionspectrophotometry(2.2.24).Comparison:moxifloxacinhydrochlorideCRS.
C.Dissolve50mgin5mLofwaterR,add1mLofdilutenitricacidR,mix,allowtostandforI.(23S)-23-des(methoxyimino)-23-[(methylsulfanyl)me-
givesreaction(a)ofchlorides(52.3.1min).andfilter.Thefiltratethoxy]moxidectin,
TESTS
Appearancethanofsolution.ThesolutioniscolouredreferencethanreferencesuspensionsolutionII(2.2.1GY)andnotnotmoremoreopalescentintenselyintendedforuseinthemanufacture2of(2.2.2,parenteralMethodpreparations,II).Ifthethansolutionreferenceisclearsolution(2.2.1GY)andnotmoreintenselyII).
coloured2(2.2.2,MethodDissolve1.0gin20mLofdilutesodiumhydroxidesolutionR.pH(2.2.3):3.9to4.6.
Dissolve0.10gin50mLofcarbondioxide-freewaterR.Specificsubstance).
opticalrotation(2.2.7): 125to 138(anhydrousJ.Rmoxidectin,=CH2-S-CH3,R′=H:7-O-[(methylsulfanyl)methyl]-Dissolve0.200gin20.0mLofamixtureofequalvolumesofacetonitrileRandwaterR.
GeneralNotices(1)applytoallmonographsandothertexts
2531
MoxonidineEUROPEANPHARMACOPOEIA
7.0
Relatedoutthetestsubstancesprotected.Liquidfromlight.
chromatography(2.2.29).CarrySulfated1.0ginaashplatinum(2.4.14crucible.
):maximum0.1percent,determinedonSolutionA.Dissolve0.50goftetrabutylammoniumhydrogensulfateASSAY
aboutLiquidand0.050500RandgmL1.0ofofanhydrouswatergofpotassiumR.Addsodium2dihydrogenmLsulfiteofphosphoricphosphateR,thendiluteacidRtoRinrelatedchromatographysubstanceswith(the2.2.29following)asdescribedmodification.inthetestfor1000.0mLwithwaterR.
Injection:testsolution(b)andreferencesolution(a).
TestCalculatethepercentagecontentofCexaminedsolutioninsolution(a).DissolveAand50.0dilutemgtoof50.0themLsubstancewiththetosamebedeclaredcontentofmoxifloxacinhydrochloride21H25ClFN3OCRS4from.thesolution.
TestSTORAGE
withsolutionsolution(b)A.
.Dilute2.0mLoftestsolution(a)to20.0mLInanairtightcontainer,protectedfromlight.
ReferenceLABELLING
hydrochloridesolution(a).Dissolve50.0mgtheCRSinsolutionAanddiluteofmoxifloxacinto50.0mLwithThewithsamesolutionsolution.A.
Dilute2.0mLofthissolutionto20.0mLforuselabelinstates,themanufacturewhereapplicable,ofparenteralthatthepreparations.substanceissuitableReferencesolution(b).Dissolve5mgofmoxifloxacinforpeakIMPURITIES
identificationSpecifiedimpurities:A,B,C,D,
E.
solutionAandCRSdilute(containingto5.0mLimpuritieswiththesameA,B,solution.C,DandE)inReference100.0mLwithsolutionsolution(c).DiluteA.Dilute1.01.0mLmLoftestofthissolutionsolution(a)toto10.0mLwithsolutionA.Column:
—size:l=0.25m,Ø=4.6mm;
—stationaryphase:end-cappedphenylsilylsilicagelforchromatographyR(5μm);A.R—temperature:45°C.
6H=-pyrrolo[3,4-R′=F:1-cyclopropyl-6,8-difluoro-7-[(4ab]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-S,7aS)-octahydro-Mobilecarboxylicacid,ofasolutionphasecontaining:mix28volumes0.5g/LofofmethanoltetrabutylammoniumRand72volumesB.RhydrogensulfateR,1.0g/Lofpotassiumdihydrogen7a=S)-octahydro-6R′=OCH3:1-cyclopropyl-6,8-dimethoxy-7-[(4aH-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-S,phosphateRand3.4g/LofphosphoricacidR.dihydroquinoline-3-carboxylicacid,Flowrate:1.3mL/min.
C.RDetection:spectrophotometerat293nm.
7a=S)-octahydro-6F,R′=OC2HH5:-pyrrolo[3,4-1-cyclopropyl-8-ethoxy-6-fluoro-7-[(4ab]pyridin-6-yl]-4-oxo-1,4-S,Injectiondihydroquinoline-3-carboxylicacid,and(c).
:10μLoftestsolution(a)andreferencesolutions(b)D.R=OCH3,R′=F:1-cyclopropyl-8-fluoro-6-methoxy-7-[(4aS,Runtime:2.5timestheretentiontimeofmoxifloxacin.
7aIdentificationdihydroquinoline-3-carboxylicS)-octahydro-6H-pyrrolo[3,4-acid,b]pyridin-6-yl]-4-oxo-1,4-withofimpurities:useE.R=F,R′=OH:1-cyclopropyl-6-fluoro-8-hydroxy-7-[(4aS,chromatogrammoxifloxacin7athepeaksduetoobtainedforpeakidentificationthechromatogramCRSandsuppliedthe
impuritieswithA,referenceB,C,DandsolutionE.(b)toidentifydihydroquinoline-3-carboxylicS)-octahydro-6H-pyrrolo[3,4-acid.
b]pyridin-6-yl]-4-oxo-1,4-Relative(retentionretention01/2008:1758impurityBtime=about=aboutwithreferencetomoxifloxacin
1.3;14impuritymin):impurityC=aboutA=1.4;about1.1;corrected6.0
impurityD=about1.6;impurityE=about1.7.Systemsuitability:referencesolution(b):
MOXONIDINE
—resolutionmoxifloxacin:minimumandimpurity1.5betweenA;
thepeaksduetoMoxonidinum
—thesuppliedchromatogramwithmoxifloxacinobtainedforissimilarpeakidentificationtothechromatogramCRS.Limits:
—correctionpeakcorrectionareasfactorsfactor:ofthefollowing:forthecalculationofcontent,multiplytheimpurityBimpurities=1.4;impuritybytheEcorresponding=3.5;
C9H12ClN5OM—impuritiesA,B,C,D,E:foreachimpurity,notmorethan[75438-57-2]
r241.7
theDEFINITION
withareareferenceofthesolutionprincipal(c)peak(0.1inperthecent);
chromatogramobtained4-Chloro-—unspecifiedimpurities:foreachimpurity,notmorethanthemethylpyrimidin-5-amine.
N-(imidazolidin-2-ylidene)-6-methoxy-2-areaContent:97.5percentto102.0percent(driedsubstance).withofreferencetheprincipalsolutionpeak(c)in(0.10theperchromatogramcent);
obtained—totalCHARACTERS
inthe:notchromatogrammorethan3obtainedtimesthewithareareferenceoftheprincipalsolutionpeak(c)Appearance:whiteoralmostwhitepowder.
(0.3percent);
Solubility—disregardmethanol,:slightlyveryslightlysolublesolubleinmethyleneinwater,chloride,sparinglyverysolubleslightlyininlimit:0.5timestheareaofsolubleinacetonitrile.
(0.05theperchromatogramcent).
obtainedwithreferencetheprincipalsolutionpeak(c)IDENTIFICATION
Water(2.5.12):maximum4.5percent,determinedon0.200g.Infraredabsorptionspectrophotometry(2.2.24).
2532
Seetheinformationsectionongeneralmonographs(coverpages)
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