pantoprazole-sodium-中國藥典標準翻譯(存儲版)
【正文】 red absorption spectrum is concordant with the reference spectrum of pantoprazole sodium (Appendix ⅩⅥ).(4) Yields the reaction characteristic of sodium salts (Appendix Ⅲ). [Inspection] Alkalinity An aqueous solution of 20 mg per ml, pH (Appendix Ⅵ H). Clarity and colour of solution Dissolve g in 10 ml of water, the solution is clear and colourless。 column temperature is 40℃. The number of the theoretical plates calculated from pantoprazole peak is not less than 2500. Inject 20 μl of reference solution, adjust detection sensitivity so that the peak height of the principle peak in the chromatogram is about 20% of full scale of the chart. Inject separately 20 μl of the test solution and the reference solution and record the chromatogram. The area of individual impurity peak is not more than times of the area (%) of the principle peak in the chromatogram obtained with the reference solution., the sum of the areas of the impurity peaks is not more than of the area (for injection) (%) or not more than the area (for oral) (%) of the principle peak in the chromatogram obtained with the reference solution. The area of any peak in the chromatogram of the test solution less than times o
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鄂ICP備17016276號-1