ORDINARY IMPURITIES翻译.docx

ORDINARY IMPURITIESTest Solution— Prepare, in the solvent specified in the monograph, a solution of the substance under test having an accurately known final concentration of about 10 mg per mL. [note—Heat or sonication may be used to dissolve the drug substance where use of such does not adversely affect the compound.] 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）Standard Solutions— Prepare, in the solvent specified in the monograph, solutions of the USP Reference Standard or designated substance having accurately known concentrations of 0.01 mg per mL, 0.05 mg per mL, 0.1 mg per mL, and 0.2 mg per mL. [note—Heat or sonication may be used to dissolve the drug substance where use of such does not adversely affect the compound.] 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/ml 0.05mg/ml 0.1mg/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— Use a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture, and the Eluant specified in the monograph. Apply equal volumes (20 μL) of the Test Solution and Standard Solutions to the plate, using a stream of nitrogen to dry the spots. 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。Allow the chromatogram to develop in a pre-equilibrated chamber until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and air-dry. View the plate using the visualization technique(s) specified. Locate any spots other than the principal spot in the chromatogram of the Test Solution, and determine their relative intensities by comparison with the chromatograms of the appropriate Standard Solutions. See discussion above with regard to reporting and specifying total ordinary impurities.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key for visualization techniques 关键的可视化技术Use UV