地喹氯铵EP标准

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1、DequaliniumChloride(PhEurmonograph1413)C30H40Cl2N4527.6522-51-1PhEurDefinitionDequaliniumchloridecontainsnotlessthan95.0percentandnotmorethantheequivalentof101.0percentof1,1¢-(decane-1,10-diyl)bis(4-amino-2-methylquinolinium)dichloride,calculatedwithreferen

2、cetothedriedsubstance.CharactersAwhiteoryellowish-whitepowder,hygroscopic,slightlysolubleinwaterandinalcohol.IdentificationFirstidentificationB,E.SecondidentificationA,C,D,E.A.Dissolveabout10mginwaterRanddiluteto100mlwiththesamesolvent.Dilute10mlofthesoluti

3、onto100mlwithwaterR.Examinedbetween230nmand350nm(2.2.25),thesolutionshows2absorptionmaxima,at240nmand326nmandashoulderat336nm.Theratiooftheabsorbancemeasuredatthemaximumat240nmtothatmeasuredatthemaximumat326nmis1.56to1.80andtheratiooftheabsorbancemeasuredat

4、themaximumat326nmtothatmeasuredattheshoulderat336nmis1.12to1.30.B.Examinebyinfraredabsorptionspectrophotometrybetween600cm-1and2000cm-1(2.2.24),comparingwiththespectrumobtainedwithdequaliniumchlorideCRS.C.To5mlofsolutionS(seeTests)add5mlofpotassiumferricyan

5、idesolutionR.Ayellowprecipitateisformed.D.To10mlofsolutionSadd1mlofdilutenitricacidR.Awhiteprecipitateisformed.FilterandreservethefiltrateforidentificationtestE.E.ThefiltratefromidentificationtestDgivesreaction(a)ofchlorides(2.3.1).TestsSolutionSDissolve0.2

6、gin90mlofcarbondioxide-freewaterR,heatingifnecessary,anddiluteto100mlwiththesamesolvent.AppearanceofsolutionSolutionSisclear(2.2.1)andcolourless(2.2.2,MethodII).AcidityoralkalinityTo5mlofsolutionSadd0.1mlofbromothymolbluesolutionR1.Notmorethan0.2mlof0.01Mhy

7、drochloricacidor0.01Msodiumhydroxideisrequiredtochangethecolouroftheindicator.RelatedsubstancesExaminebyliquidchromatography(2.2.29).TestsolutionDissolve10.0mgofthesubstancetobeexaminedinthemobilephaseanddiluteto10.0mlwiththemobilephase.Referencesolution(a)

8、Dissolve10.0mgofdequaliniumchlorideforperformancetestCRSinthemobilephaseanddiluteto10.0mlwiththemobilephase.Referencesolution(b)Dissolve10.0mgofdequaliniumchlorideCRSinthemobilephaseanddiluteto10.0mlwi