11/21/2016

USPMonographs:MiconazoleNitrate

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MiconazoleNitrate
C18H14Cl4N2OHNO3

479.14

1HImidazole,1[2(2,4dichlorophenyl)2[(2,4dichlorophenyl)methoxy]ethyl],mononitrate.
1[2,4Dichloro [(2,4dichlorobenzyl)oxy]phenethyl]imidazolemononitrate

[22832877].

MiconazoleNitratecontainsnotlessthan98.0percentandnotmorethan102.0percentof
C18H14Cl4N2OHNO3,calculatedonthedriedbasis.
PackagingandstoragePreserveinwellclosedcontainers,protectedfromlight.
USPReferencestandards 11 USPMiconazoleNitrateRS.USPEconazoleNitrateRS.
Identification
A: InfraredAbsorption 197K .
B: UltravioletAbsorption 197U
Solution:400gpermL.
Medium:0.1Nhydrochloricacidinisopropylalcohol(1in10).
Lossondrying 731 Dryitat105 for2hours:itlosesnotmorethan0.5%ofitsweight.
Residueonignition 281 :notmorethan0.2%.
Relatedcompounds
MobilephasePrepareafilteredanddegassedmixtureof0.2Mammoniumacetate,methanol,andacetonitrile(38:32:30).
Makeadjustmentsifnecessary(seeSystemSuitabilityunderChromatography 621 ).
ResolutionsolutionDissolveaccuratelyweighedquantitiesofUSPMiconazoleNitrateRSandUSPEconazoleNitrateRS
inMobilephasetoobtainasolutionhavingknownconcentrationsofabout25gofeachpermL.
TestsolutionTransfer100mgofMiconazoleNitratetoa10mLvolumetricflask,addMobilephasetovolume,andmix.
DilutedtestsolutionDiluteanaccuratelymeasuredvolumeoftheTestsolutionquantitatively,andstepwiseifnecessary,
withMobilephasetoobtainasolutioncontaining25gofmiconazolenitratepermL.

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11/21/2016

USPMonographs:MiconazoleNitrate

Chromatographicsystem(seeChromatography 621 )Theliquidchromatographisequippedwitha235nmdetector

anda4.6mm10cmcolumnthatcontains3mpackingL1.Theflowrateisabout2mLperminute.Chromatographthe
Resolutionsolution,andrecordthepeakresponsesasdirectedforProcedure:therelativeretentiontimesareabout0.5for
econazoleand1.0formiconazoletheresolution,R,betweeneconazoleandmiconazoleisnotlessthan10andthe
relativestandarddeviationforreplicateinjectionsisnotmorethan2.0%.
ProcedureSeparatelyinjectequalvolumes(about10L)oftheTestsolutionandDilutedtestsolutionintothe
chromatograph,recordthechromatogramsforatimethatis1.2timestheretentiontimeofthemainpeak,andmeasurethe
responsesofallpeaks,excludingthepeakrepresentingnitrateionandanypeakproducingaresponselessthan0.2times
theresponseofthemainpeak.Theresponseofanyindividualpeak,otherthanthemainpeakinthechromatogramofthe
Testsolution,isnotgreaterthanthatofthemainpeakinthechromatogramoftheDilutedtestsolution(0.25%),andthe
sumoftheresponsesofallpeaks,otherthanthemainpeakinthechromatogramoftheTestsolution,isnotgreaterthan
twicetheresponseofthemainpeakinthechromatogramoftheDilutedtestsolution(0.5%).
Residualsolvents 467 :meetstherequirements.
(OfficialJanuary1,2007)
AssayDissolveabout350mgofMiconazoleNitrate,accuratelyweighed,in50mLofglacialaceticacid,andtitratewith
0.1NperchloricacidVS,determiningtheendpointpotentiometrically,usingaglasscalomelelectrodesystem.Performa
blankdetermination,andmakeanynecessarycorrection.EachmLof0.1Nperchloricacidisequivalentto47.92mgof
C18H14Cl4N2OHNO3.
AuxiliaryInformationStaffLiaison:BehnamDavani,Ph.D.,MBA,SeniorScientist
ExpertCommittee:(MDAA05)MonographDevelopmentAntiviralsandAntimicrobials
USP29NF24Page1435
PhoneNumber:13018168394

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