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System suitability: reference solution: — the chromatogram obtained is qualitatively similar to the chromatogram supplied with follitropin CRS; — by comparison with the chromatogram supplied with follitropin CRS, identify the peaks due to neutral, mono-, di-, tri- and tetra-sialylated forms; determine the area of each peak and express it as a percentage of the total; calculate the Z number using the following expression: A0 = peak area percentage due to the neutral form; A1 = peak area percentage due to the mono-sialylated form; A2 = peak area percentage due to the di-sialylated form; A3 = peak area percentage due to the tri-sialylated form; A4 = peak area percentage due to the tetra-sialylated form. The Z number obtained for the reference solution is in the range 177-233. Examine the chromatogram obtained with the test solution and calculate the Z number as described above. Result Z = 177-233. 求教:文中的“Znumber”具体指的是什么?代表什么意思? 非常感谢!! |
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