USP〈1225〉药典规程的验证(中英文对照)(14)

analytical procedure.

范围的定义---- 分析规程的范围是分析物的较高浓度和较低浓度（含）之间的区间，已经证实在此区间内，使用该规程进行测定具有适当水平的精密度、准确度、和线性。该范围通常以与该分析规程得到的测试结果相同的单位表示，例如百分比，百万分率等。

Determination of Linearity and Range---- Linearity should be established across the range of the analytical procedure. It should be established initially by visual examination of a plot of signals as a function of analyte concentration of content. If there appears to be a linear relationship, test results should be established by appropriate statistical methods (e.g., by calculation of a regression line by the method of least squares). Data from the regression line itself may be helpful to provide mathematical estimates of the degree of linearity. The correlation coefficient, y-intercept, slope of the regression line, and residual sum of squares should be submitted.

线性和范围的确定---- 应在分析规程整个范围内确立线性。线性的确立最开始应该通过目测代表内容物中待分析物浓度的多个信号构成的图表来进行。如果其呈现线性关系，测试结果应该通过适当的统计学方法（例如，以最小二乘方来计算回归线）来确立。来自回归线自身的数据可以用于提供线性程度的数学评估。应该提交其相关系数、Y轴截距、回归线斜率、残差平方和。

The range of the procedure is validated by verifying that the analytical procedure provides acceptable precision, accuracy, and linearity when applied to sample containing analyte at the extremes of the range as well as within the range.

通过用规程分析含有待分析物的、浓度在范围的极限值上和在范围中的样品，确认该分析规程提供了可接受的精密度、准确度、线性，以进行该规程范围的验证。

ICH recommends that, for the establishment of linearity, a minimum of five concentrations normally be used. It is also recommended that the following minimum specified ranges should be considered: ICH建议，为了确立线性，通常使用最少五个浓度。其还建议，应考虑下列的最小范围的规定。

Assay of a Drug Substance (or a finished product): from 80% to 120% of the test concentration.

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