《韩国药典》KP9.0英文版电子版下载Monographs Part I (J-Z) Korean Pharmacopoeia.pdf

《韩国药典》KP9.0英文版电子版下载Monographs Part I (J-Z) Korean Pharmacopoeia.pdf

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JosamycinPropionateCHCH3OH3CHOOHCH3OHHHCH3JosamycinPropionateisaderivativeofjosamycin.JosamycinPropionatecontainsnotlessthan843g（potency）permgofjosamycin（C42H69NO15:

828.00）,calculatedonthedriedbasis.DescriptionJosamycinPropionateisawhitetolightyellowishwhitecrystallinepowder,andisodorlessandtasteless.JosamycinPropionateisverysolubleinmethanolorinethanol,solubleinether,andpracticallyinsolubleinwater.Identification（l）Dissolve2mgofJosamycinPro-pionatein5mLofsulfuricacid:

thesolutionturnstored-brown.

（2）DeterminetheabsorptionspectrumofasolutionofJosamycinPropionateinmethanol（lin100000）asdirectedunderUltraviolet-visibleSpectrophotometry,itexhibitsmaximumbetween230nmand233nm.PurityHeavymetals-Proceedwith1.0gofJosamy-cinPropionateaccordingtoMethod2andperformthetest.Preparethecontrolsolutionwith3.0mLofstan-dardleadsolution（notmorethan30ppm）.LossonDryingNotmorethan2.0%（0.5g,inva-cuum,60C,3hours）.ResidueonignitionNotmorethan0.2%（1g）.AssayTheCylinder-platemethodmethod（l）Agarmediaforseedandbaselayer-UsethemediuminI2l）

（1）CDunderMicrobialAssayforAntibiotics.

（2）Testorganism-BacillussubtilisATCC6633.（3）Weighaccuratelyabout20mg（potency）ofJo-samycinPropionate,dissolvein10mLofmethanol,andadd0.06mol/Lphosphatebuffersolution,pH5.6tomakesolutionsothateachmLcontains400.0g（potency）.Takeexactlyasuitableamountofthissolu-tion,add0.06mol/Lphosphatebuffersolution,pH5.6tomakesolutionssothateachmLcontains80.0g（potency）and20.0g（potency）,andusethesesolu-tionsasthehighconcentrationtestsolutionandthelowconcentrationtestsolution,respectively.Separately,weighaccuratelyabout20mgofJosamycinPropionateKP9539RS,dissolveinl0mLofmethanol,andadd0.06mol/Lphosphatebuffersolution,pH5.6tomakesolutionsothateachmLcontains400.0g（potency）,andusethissolutionasthestandardstocksolution.Keepthestan-dardstocksolutionatnotexceeding5Candusewith-in3days.Takeexactlyasuitableamountofthestan-dardstocksolutionbeforeuse,add0.06mol/Lphos-phatebuffersolution,pH5.6tomakesolutionssothateachmLcontains80.0g（potency）and20.0g（po-tency）,andusethesesolutionsasthehighconcentra-tionstandardsolutionandthelowconcentrationstan-dardsolution,respectively.PerformthetestwiththesesolutionsaccordingtotheCylinder-platemethod（I8）asdirectedunderMicrobialAssayforAntibiotics.PackagingandStoragePreserveintightcontainers.KanamycinMonosulfateKanamycinMonosulfateisthesulfateofanaminogly-cosidesubstancehavingantibacterialactivityproducedbythegrowthofStreptomyceskanamyceticus.KanamycinMonosulfatecontainsnotlessthan750g（potency）permgofkanamycin（C18H36N4O11:

484.50）,calculatedonthedriedbasis.DescriptionKanamycinMonosulfateisawhitetoyellowishwhitepowder,isodorlessorhasalittlebitofodor,andhasalittlebitofbittertaste.KanamycinMonosulfateisfreelysolubleinwater,andpracticallyinsolubleinethanolorinether.Identification

（1）To50mgofKanamycinMonosul-fateadd3mLofwateranddissolve,andadd2mLofanthroneTS:

ablue-purplecolordevelops.

（2）To20mgofKanamycinMonosulfate,add2mLof0.06mol/Lphosphatebuffersolution,pH5.6,dis-solve,andaddlmLofninhydrinTSandboil:

ablue-purplecolordevelops.（3）To10mgofKanamycinMonosulfateadd1mLofwateranddissolve,andaddlmLofninhydrinsolu-tioninn-butanol（1in500）and0.5mLofpyridine,_andheatinwaterbathfor5minutesandaddlmLofwater:

adarkpurplecolordevelops.（4）AsolutionofKanamycinMonosulfateresponds540Monographs.PartItoQualitativeTestsforsulfatesalt.pHThepHofasolutionobtainedbydissolving0.1gofKanamycinMonosulfatein10mLofwaterisbe-tween6.5and8.5.SterilityTestItmeetstherequirement,whenKana-mycinMonosulfateisusedinasterilepreparation.BacterialEndotoxinsLessthan0.50EUpermgofkanamycin,whenKanamycinMonosulfateisusedinasterilepreparation.LossonDryingNotmorethan4.0%（0.1g,inva-cuum,60C,3hours）.ResidueonIgnitionNotmorethan1.0%（1g）.AssayTheCylinder-platemethodmethod

（1）Agarmediaforseedandbaselayer-UsethemediuminI21）

（1）CDunderMicrobialAssayforAntibiotics.

（2）Testorganism-BacillussubtilisATCC6633.（3）Weighaccuratelyabout20mg（potency）ofKa-namycinMonosulfate,dissolveinsterilepurifiedwater,tomakeasolutionsothateachmLcontains400.0g（potency）,andusethissolutionastheteststocksolu-tion.Takeexactlyasuitableamountofthissolution,add0.1mol/Lphosphatebuffersolution,pH8.0tomakesolutionssothateachmLcontains20.0g（po-tency）and5.0g（potency）,andusethesesolutionsasthehighconcentrationtestsolutionandthelowconcen-trationtestsolution,respectively.Separately,weighac-curatelyabout20mgofKanamycinSulfateRS,pre-viouslydried,dissolvein0.05mol/Lphosphatebuffersolution,pH6.0tomakesolutionsothateachmLcon-tains400.0g（potency）,andusethissolutionasthestandardstocksolution.Keepthestandardstocksolu-tionbetween5Cand15C,andusewithin30days.Takeexactlyasuitableamountofthestandardstocksolutionbeforeuse,add0.1mol/Lphosphatebufferso-lution,pH8.0tomakesolutionssothateachmLcon-tains20.0g（potency）and5.0g（potency）,andusethesesolutionsasthehighconcentrationstandardsolu-tionandthelowconcentrationstandardsolution,re-spectively.Performthetestwiththesesolutionsaccord-ingtotheCylinder-platemethod（I8）asdirectedunderMicrobialAssayforAntibiotics.PackagingandStoragePreserveintightcontainers.KanamycinSulfateKanamycinSulfateisthesulfateofanaminoglycosidesubstancehavingantibacterialactivityproducedbythegrowthofStreptomyceskanamyceticus.KanamycinSulfateispreparedbyaddingnotmorethan1molofsulfuricacidto1molofkanamycinmonosul-fate.KanamycinSulfatecontainsnotlessthan600g（po-tency）permgofkanamycin（C18H35N4O11:

484.50）,calculatedonthedriedbasis.DescriptionKanamycinSulfateisawhitetoyello-wishwhitepowder,isodorlessorhasalittlebitofodor,andhasalittlebitofbittertaste.KanamycinSulfateisverysolubleinwater,andpracti-callyinsolubleinethanol,inacetone,orinether.IdentificationPerformthetestaccordingtoIdentifi-cationin_KanamycinMonosulfate.pHThepHofasolutionobtainedbydissolving0.5gofKanamycinMonosulfatein10mLofwaterisbe-tween6.0and8.5.SterilityTestItmeetstherequirement,whenKana-mycinSulfateisusedinasterilepreparation.PyrogenTestItmeetstherequirement,whenKana-mycinSulfateisusedinasterilepreparation,.WeighanappropriateamountofKanamycinSulfate,dissolveinwater,makethesolutionsothateachmLcontains10.0mg,andusethesolutionasthetestsolution.Theamountofinjectionis1.0mLofthetestsolutionperkgofbodyweightofrabbit.LossonDryingNotmorethan5.0%（0.1g,inva-cuum,60C,3hours）.AssayPerformthetestaccordingtoAssayin_Kana-mycinMonosulfate.Weighaccuratelyabout20mg（potency）ofKanamycinSulfate,dissolveinsterilepu-rifiedwatertomakeasolutionsothateachmLcon-tains400.0g（potency）,andusethissolutionastheteststocksolution.Takeexactlyasuitableamountofthissolution,add0.1mol/Lphosphatebuffersolution,pH8.0tomakesolutionssothateachmLcontains20.0g（potency）and5.0g（potency）,andusethesesolu-tionsasthehighconcentrationtestsolutionandthelowconcentrationtestsolution,respectively.PackagingandStoragePreserveintightcontainers.KainicAcidH（NC02HHAT:

H2C02HH20H2C=CRICH3KainicAcid,previouslydried,containsnotlessthan99.0%andnotmorethan101.0%ofkainicacid（C10H1sNO4:

213.23）.DescriptionKainicAcidiswhitecrystalsorcrystal-linepowder,isodorlessandhasanacidtaste.KainicAcidissparinglysolubleinwaterorinwarmwater,veryslightlysolubleinglacialaceticacidorinethanolandpracticallyinsolubleinether.KainicaciddissolvesindilutehydrochloricacidorinsodiumhydroxideTS.Meltingpoint-About252C（withdecomposition）.pH-ThepHofasolutionofKainicAcid（1in100）isbetween2.8and3.5.Identification

（1）To5mLofasolutionofKainicAcid（1in5000）,add1mLofninhydrinTSandwarminawater-bathatatemperaturebetween60Cand70Cfor5minutes:

ayellowcolorisproduced.

（2）Dissolve50mgofKainicAcidin5mLofgla-cialaceticacidandadd0.5mLofbromineTS:

thecol-orofbrominedisappearsimmediately.SpecificOpticalRotationa0:

Between-13and-17（0.5g,water,50mL,200mm）.Purity

（1）Clarityandcolorofsolution-Dissolve0.10gofKainicAcidin10mLofwater:

thesolutionisclearandcolorless.

（2）Chloride-Take0.5gofKainicAcidinaplati-numcrucible,dissolvein5mLofsodiumcarbonateTSandevaporateInawater-bathtodryness.Heatthecruc-ibleslowlyatfirstandthenigniteuntilthesampleisalmostincinerated.Aftercooling,add12mLofdilutenitricacidtotheresidue,dissolvebywarmingandfilter.Washtheresiduewith15mLofwater,combinethewashingsandthefiltrateandaddwatertomake50mL.KP9541Performthetest（notmorethan0.021%）.Controlsolution-Add5mLofsodiumcarbonateTSto0.30mLof0.01mol/LhydrochloricacidVSandproceedasdirectedabove.（3）Sulfate-Dissolve0.5gofKainicAcidin40mLofwaterbywarming.Cool,add1mLofdilutehy-drochloricacidandwatertomake50mLandperformthetest.Preparethecontrolsolutionwith0.30mLof0.005mol/LsulfuricacidVS（notmorethan0.028%）.（4）Ammonium-Take0.25gofKainicAcidandperformthetest.Preparethecontrolsolutionwith5.0mLofstandardammoniumsolution（notmorethan0.02%）.（5）Heavymetals-Proceedwith1.0gofKainicAcidaccordingto