EP7.0--盐酸莫西沙星

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

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