如果流动相由三种成分组成,当系统适用性达不到要求时你是如何调整流动相的呢?怎样调整才是在药典允许的范围内呢?下面是一个典型的例子,解释得比较复杂,还是分开一句一句的翻译吧:
1. For the second component, 30% of 35 is 10.5% absolute, which exceeds the maximum permitted
change of ±10% absolute in any component.
2. Therefore the second component may be adjusted only within the range of 25% to 45% absolute.
For the third component, 30% of 5 is 1.5% absolute.
3. In all cases, a sufficient quantity of the first component is used to give a total of 100%.
4. Therefore, mixture ranges of 50:45:5 to 70:25:5 or 58.5:35:6.5 to 61.5:35:3.5 would meet the
requirement.