谷胱甘肽欧洲药典5.1标准.docx

《谷胱甘肽欧洲药典5.1标准.docx》由会员上传分享，免费在线阅读，更多相关内容在应用文档-天天文库。

1、GLUTATHIONEGlutathionumC10H17N3O6SMr307.3DEFINITIONL-?-Glutamyl-L-cysteinylglycine.Content:98.0percentto101.0percent(driedsubstance).谷胱甘肽C10H17N3O6SMr307.3定义描述L－r谷氨酰基－L－半胱氨酰基甘氨酸含量：按干燥品计算，98.0%-101.0%CHARACTERSAppearance:whiteoralmostwhite,crystallinepowderor

2、colourlesscrystals.Solubility:freelysolubleinwater,veryslightlysolubleinethanol(96percent)andinmethylenechloride.性状外观性状：白色或几乎白色结晶性粉末或无色的结晶。溶解度：易溶于水，微溶于96%乙醇及二氯甲烷。IDENTIFICATIONA.Itcomplieswiththetestforspecificopticalrotation(seeTests).B.Infraredabsorptionsp

3、ectrophotometry(2.2.24).Comparison:glutathioneCRS.鉴别A比旋度符合特定的光学旋转测定（见测定项）。B红外吸收光谱检测（2.2.24）对比：谷胱甘肽CRS.TESTSSolutionS.Dissolve5.0gindistilledwaterRanddiluteto50mlwiththesamesolvent.Appearanceofsolution.SolutionSisclear(2.2.1)andcolourless(2.2.2,MethodII).Spec

4、ificopticalrotation(2.2.7):?15.5to?17.5(driedsubstance).Dissolve1.0ginwaterRanddiluteto25.0mlwiththesamesolvent.测定溶液S：取本品5.0g，蒸馏水R溶解并稀释至50ml。溶液澄清度溶液S澄清(2.2.1)，无色(2.2.2,MethodII)比旋度（2.2.7)－15.5。～－17.5°（干品物质）取本品1.0g，蒸馏水R溶解并稀释至25.0ml。Relatedsubstances.Capillary

5、electrophoresis(2.2.47).Preparethesolutionsimmediatelybeforeuse.Internalstandardsolution(a).Dissolve0.100gofphenylalanineRintheelectrolytesolutionanddiluteto50.0mlwiththesamesolution.Internalstandardsolution(b).Dilute10.0mlofinternalstandardsolution(a)to100.

6、0mlwiththeelectrolytesolution.Testsolution(a).Dissolve0.200gofthesubstancetobeexaminedintheelectrolytesolutionanddiluteto10.0mlwiththesamesolution.Testsolution(b).Dissolve0.200gofthesubstancetobeexaminedininternalstandardsolution(b)anddiluteto10.0mlwiththesa

7、mesolution.Referencesolution(a).Dissolve20mgofthesubstancetobeexaminedininternalstandardsolution(a)anddiluteto10.0mlwiththesamesolution.Referencesolution(b).Dilute5.0mlofreferencesolution(a)to50.0mlwiththeelectrolytesolution.Referencesolution(c).Dissolve0.20

8、0gofthesubstancetobeexaminedin5mloftheelectrolytesolution.Add1.0mlofinternalstandardsolution(a),0.5mlofa2mg/mlsolutionofL-cysteineR(impurityB)intheelectrolytesolution,0.5mlofa2mg/mlsolutionofL-g