USP〈1225〉药典规程的验证(中英文对照)(13)

validated by the analysis of a suitable number of samples known to be near, or prepared at, the quantitation limit.

对于展示出背景噪音的仪器分析规程，ICH文件描述了一个通用方法，用来比较从以下样品测得的信号，这些样品分别为含已知低浓度被分析物的样品和空白样品。这样就确立了能够可靠地定量待分析物的最低浓度。可接受的典型信噪比是10:1。其他方法取决于校正曲线斜率的测定和响应值的标准差。无论用什么方法，均应该在随后通过分析适当数量的、已知接近或制备于定量限度的样品，来验证定量限度。

LINEARITY AND RANGE线性和范围

Definition of Linearity---- The linearity of an analytical procedure is its ability to elicit test results that are directly, or by a well-defined mathematical transformation, proportional to the concentration of analyte in samples within a given range. Thus, in this section, “linearity” refers to the linearity of the relationship of concentration and assay measurement. In some cases, to attain linearity, the concentration and/or the measurement may be transformed. (Note that the weighing factors used in the regression analysis may change when a transformation is applied.) Possible transformations may include log, square root, or reciprocal, although other transformations are acceptable. If linearity is not attainable, a non-linear model may be used. The goal is to have a model, whether linear or non-linear, that describes closely the concentration-response relationship.

线性的定义---- 分析规程的线性是该规程直接地、或通过明确给出的数学转换而间接地，得出与特定范围内的样品中待分析物浓度呈比例关系的测试结果的能力。因此，在此部分，“线性”是指浓度与检验结果之间的线性关系。在某些情况下，为了实现线性，浓度和/或测量数据可以进行转换。（注意：当进行转换时，在回归分析中用到的权重因子可以变化。）虽然其他转换方式也是可以接受的，但是可能的转换包括对数、平方根、倒数。如果无法实现线性，可以使用非线性模型。其目的是得到一个精确描述浓度-响应值关系的模型，不论是线性还是非线性。

Definition of Range---- The range of an analytical procedure is the interval between the upper and lower levels of analyte (including these levels) that have been demonstrated to be determined with a suitable level of precision, accuracy, and linearity using the procedure as written. The range is normally expressed in the same units as test results (e.g., percent, parts per million) obtained by the

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