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wolfmanhd

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经色谱条件耐用性检查(改变流速、柱温、检测波长、流动相比例、流动相pH值、色谱柱等条件),本色谱条件在小幅变动范围内,对有关物质检查无明显影响,表明该方法耐用性良好;专属性试验结果表明,本品与降解杂质能完全分离,该方法专属性好;并对本品有关物质检查方法进行了方法学验证,
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jiangguofeng

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真强必胜: 金币+1, good 2014-03-16 11:12:05
wolfmanhd: 金币+30, 翻译EPI+1, ★★★很有帮助 2014-03-16 20:44:13
The measuration of robustness of chromatographic conditions, under small variations in flow rate, column temperature, detection wavelength, mobile phase ratio, mobile phase pH value, chromatographic column, etc, shows that this method has a good robustness and there is ho significant effect on the test for related substances.The results of the specificity test show that the product can be completely separated from degradation impurities,which indicates a good specificity of this method.The methodology validation of the test for related substanceshas in the product also been performed,
2楼2014-03-16 10:39:14
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