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D.E..—_F.A.INGREDIENTNAME:METRONIRAZOLE13ENZOATEChemicalName:
5-nitro-lH-imidazol-l-ylethylbenzoate
CommonName:Chemicalgradeordescriptionofthestrength,quality,andpurityoftheingredient:
Assay:99.54%calculatedasdriedbasis
Informationabouthowtheingredientissupplied:
Whiteorslightlyyellowish,crystallinepowder
Informationaboutrecognitionofthesubstanceinforeignpharmacopoeias:
TheIndianPharmacopoeiaVolumeI(A-P)1985
G.Bibliographyofavailablesafetyandefficacydataincludingpeerreviewedmedicalliterature:
Stolze,K.EliminationofElyzol25%Dentagelmatrixfromperiodontalpockets.J
C/in
Periodontal,1995;22(3):185-187.
H.Informationaboutdosageformsused:
SuspensionL
Informationaboutstrength:.-
400mg-3timesdaily,for5-10days
#-%
J.Informationaboutrouteofadministration:
Topically
KStabilitydata:
Meltsatabout99-102°Keepcontainertightlyclosed
L.Formulations:M.MiscellaneousInformation:
___
Page-2-
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L—______.~.—..,.-..~,———.=—-_-.---........—__-—.,.——-—-....-._
MilanrllthDecember
1997
.....-..~.
2
x25-kgdrums
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ANALYSISCERTIFICATE
............N.O............3.2.4.3..............................................................................................................
YourOral.No...........of..,..h.e,e,.,.l.,O.t.k...e.C,C~.,....9.$lZ9..$lZ.........OurRef.No.............2..9.~.~.......................................................................QuantityMATERIAL
.METRONIDA20LEBEN,ZOATEB.P.Batch.........,,,,,.,..,.,.,,,..rn,ir,o,n,iedKG
50-0712.....................................................................................,,,,,,.,....................,,,,,.,,....,.,.,,.,,,,,,...,,,,,,,.,,,Empiricalformula....................................Molecularweight.....Aspect..........micronized
powderColor,.....,.slig,.e,.llow.sh,...
Odor...TasteMeltingpoint..............9.?.......!02...C...............................”“’Boilingrange.....
.....................
Volubilitypracticallyinsoluble
.inwater;freely.solubleinDichloromethone;solubleiflAceton~..............“’-..................,,,..,.......,.,,.,,,,,,,,,,,,,,,.,,.,.,,,,
PH.....
(acidi,ty),O.O?.MI....,.,...,.......,,.
I
I
I
Specificrotation,,..,.,.,,,,,,,-,,,,,,,,,,,,,.,,,,,,,,,,...,,,,,.,,,,,,,,,,,,,,,,,,,,,,.............Lightabsorption...,.,.,,Lossondrying.,.,..,.,.,,,..?.:.1??3%.0.0398%esidueonignition*..Chloride..............................................................................Suifate................................................................................//Heavymetals........k.e.ss...~an20PPm.Identification.........
..).Melting.............99...-.02°CB)complies““"'c)""`''"'""''"'"''''""'"""'"""'"
Titer(Assay)99.54%calculatedasdriedbasis,.
D).E)
.........................................................................,.,,,..,,,..,,,,,,,.,,,,,,.,,,.,..,,.,,
Otherrequirements,notes.~es??l,~sof..tes.~.or,.,ana.@ls...a.s....PBr...B...p...........
Relatedsubstancespa......te......
..........................
d
Analyst/
3
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//
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