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发表于 2015-5-6 08:01:05
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请对照美国药典准确翻译,
以下百度翻译请参考:
Determination method:
The determination of the sample solution as the test solution for test. Precise amount of sample solution for XXml, in a XXXml flask, 0.5mol/L (acetic acid sodium acetate solution to adjust the pH value to 7 with ice) - acetonitrile (6:1) as diluent to the scale, shake, as the control solution. Precise amount of 1ml control solution, placed in a 10ml flask, with the diluent to the scale, shake, as the system suitability solution. The solution of 1ml system for injection, HPLC, the signal-to-noise ratio should be greater than 10, precise amount of sample solution and standard solution 1ml, were injected into the HPLC at -5 DEG C under the condition of low temperature, record the chromatogram. According to their own control method of impurities. |
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