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380/QuinineHydrochloride/ Monographs FCCV

时间:2014-1-15 16:59:47 作者:1442018592 来源:38 阅读:3680次
380/QuinineHydrochloride/ Monographs FCCV
380/QuinineHydrochloride/ Monographs FCCV
Lead Notmorethan2mg/kg.
LossonDrying Notmorethan0.5%.
ResidueonIgnition Notmorethan0.1%.
TESTS
Assay Dissolveabout400mgofsample,accurately
weighed,inamixtureof10mLofglacialaceticacidand10
mLofmercuricacetateTS,warmingslightlytoeffectsolution.
Cooltoroomtemperature,add2dropsofcrystalvioletTS,
andtitratewith0.1 N perchloricacid.
Caution:Handleperchloricacidinanappropriate
fumehood.
Performablankdetermination(see GeneralProvisions),and
makeanynecessarycorrection.Eachmilliliterof0.1 N per-
chloricacidisequivalentto20.56mgofC8H11NO3·HCl.
ChlorideContent Dissolveabout500mgofsample,accu-
ratelyweighed,in50mLofmethanolinaglass-stoppered
flask.Add5mLofglacialaceticacidand2to3dropsof
eosinYTS,andtitratewith0.1 N silvernitrate.Eachmilliliter
of0.1 N silvernitrateisequivalentto3.545mgofchloride
(Cl).
Lead Determineasdirectedinthe FlameAtomicAbsorption
SpectrophotometricMethod under LeadLimitTest,Appendix
IIIB,usinga5-gsample.
LossonDrying Determineasdirectedunder LossonDry-
ing,AppendixIIC,butdrythesampleinavacuumoversilica
gelfor4h.
ResidueonIgnition Determineasdirectedunder Residue
onIgnition,AppendixIIC,ignitinga2-gsample.
PackagingandStorage Storeintight,light-resistantcon-
tainers,andavoidexposuretosunlight.
QuinineHydrochloride
N
H
HO
H
H
CH2
H3CO
N
·HCl·2H2O
C20H24N2O2·HCl·2H2OFormulawt396.91
1mLofalcohol,inabout7mLofglycerin,andinabout1
mLofchloroform.Itisveryslightlysolubleinether.
Function Flavoringagent.
REQUIREMENTS
Identification
A.Add1or2dropsofbromineTSfollowedby1mLof
6 N ammoniumhydroxideto5mLofa1:1000aqueous
solution.Theliquidturnsemeraldgreen,causedbytheforma-
tionofthalleioquin.
B.A1:100aqueoussolutionislevorotatory[see Optical
(Specific)Rotation,AppendixIIB].
C.Asamplegivespositivetestsfor Chloride,Appendix
IIIA.
Assay Notlessthan99.0%andnotmorethan101.5%of
C20H24N2O2·HCl,calculatedonthedriedbasis.
Chloroform–AlcoholInsolubleSubstances Passestest.
LossonDrying Notmorethan10.0%.
Optical(Specific)Rotation []D
25°
:Between−247°and
−252°.
OtherCinchonaAlkaloids Passestest.
ReadilyCarbonizableSubstances Passestest.
ResidueonIgnition Notmorethan0.15%.
Sulfate Notmorethan0.05%.
TESTS
Assay Dissolveabout150mgofsample,accurately
weighed,in20mLofaceticanhydride;add2dropsofmala-
chitegreenTSand5.5mLofmercuricacetateTS;andtitrate
with0.1 N perchloricacidfromamicroburettoayellow
endpoint.
Caution:Handleperchloricacidinanappropriate
fumehood.
Performablankdetermination(see GeneralProvisions),and
makeanynecessarycorrection.Eachmilliliterof0.1 N per-
chloricacidisequivalentto17.99mgofC20H24N2O2·HCl.
Chloroform–AlcoholInsolubleSubstances Onegramof
sampledissolvescompletelyin7mLofa2:1(v/v)mixture
ofchloroform:absolutealcohol.
LossonDrying Determineasdirectedunder LossonDry-
ing,AppendixIIC,dryingasampleat120°for3h.
Optical(Specific)Rotation Determineasdirectedunder
Optical(Specific)Rotation,AppendixIIB,usingasolution
containing200mgofsamplein10mLof0.1 N hydrochlo-
ricacid.
OtherCinchonaAlkaloids Dissolveabout2.5gofsample3680
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