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ORDINARY IMPURITIES翻译

发布时间：2024-04-26 03:12:34 来源：文档文库

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ORDINARYIMPURITIES
TestSolution—Prepare,inthesolventspecifiedinthemonograph,asolutionofthesubstanceundertesthavinganaccuratelyknownfinalconcentrationofabout10mgpermL.[note—Heatorsonicationmaybeusedtodissolvethedrugsubstancewhereuseofsuchdoesnotadverselyaffectthecompound.]
供试液的制备：按品种项下规定的溶剂，取适量的供试品，精密称定，用该溶剂溶解并制成最终浓度为大约10mg/ml（备注：可利用加热或者超声的方法使之完全溶解，但该方法不得给样品带来不利影响）
StandardSolutions—Prepare,inthesolventspecifiedinthemonograph,solutionsoftheUSPReferenceStandardordesignatedsubstancehavingaccuratelyknownconcentrationsof0.01mgpermL,0.05mgpermL,0.1mgpermL,and0.2mgpermL.[note—Heatorsonicationmaybeusedtodissolvethedrugsubstancewhereuseofsuchdoesnotadverselyaffectthecompound.]
対照液的制备：按品种项下规定的溶剂，取适量的USP标准品或指定的物质，精密称定，用该溶剂溶解并制成浓度为0.01mg/ml0.05mg/ml0.1mg/ml和0.2mg/ml（备注：可利用加热或者超声的方法使之完全溶解，但该方法不得给样品带来不利影响）
Procedure—Useathin-layerchromatographicplatecoatedwitha0.25-mmlayerofchromatographicsilicagelmixture,andtheEluantspecifiedinthemonograph.Applyequalvolumes(20µLoftheTestSolutionandStandardSolutionstotheplate,usingastreamofnitrogentodrythespots.

操作过程：使用涂有一层0.25毫米厚的色谱硅胶混合物的薄层色谱板和品种项下规定的洗脱液，分别用20µL的测试溶液和标准溶液点板，用氮气流吹干斑点。
Allowthechromatogramtodevelopinapre-equilibratedchamberuntilthesolventfronthasmovedaboutthree-fourthsofthelengthoftheplate.Removetheplatefromthechamber,andair-dry.Viewtheplateusingthevisualizationtechnique(sspecified.LocateanyspotsotherthantheprincipalspotinthechromatogramoftheTestSolution,anddeterminetheirrelativeintensitiesbycomparisonwiththechromatogramsoftheappropriateStandardSolutions.Seediscussionabovewithregardtoreportingandspecifyingtotalordinaryimpurities.
将点好样的薄层板放入加有品种项下规定的展开液（洗脱液）的展开缸中，待溶剂展开至薄层板的约四分之三处，拿出薄层板，在空气中晾干。然后用规定的可视化技术，将供试液除主斑点外的其它任意斑点与対照液的比较，看相对强度。来讨论报告和指定的总普通杂质
keyforvisualizationtechniques
关键的可视化技术
(1UseUVlightat254nmandatabout366nm.
254nm和366nm的紫外灯
(2UseIodoplatinateTS.

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