USP〈1225〉药典规程的验证(中英文对照)(7)

of either the degree of reproducibility or of repeatability of the analytical procedure under normal operating conditions. In this context, reproducibility refers to the use of the analytical procedure in different laboratories, as in a collaborative study. Intermediate precision (as known as ruggedness) express within-laboratory variation, as on different days, or with different analysts or equipment within the same laboratory. Repeatability refers to the use of the analytical procedure within a laboratory over a short period of time using the same analyst with the same equipment.

定义---- 分析规程的精密度是当该分析规程单独分析均质样品的多个样本时，若干检验结果的一致程度。分析规程的精密度通常以一系列测量数值的标准差或相对标准差（变异系数）来表示。精密度可以是分析规程在普通操作条件下可重现性或可重复性程度的度量单位。在此内容里，可重现性涉及在协作研究中，分析规程在不同实验室的使用。中间精密度（也称为“耐久性”）体现了在实验室内的差异，如在相同的实验室，但在不同的日期，或使用不同的分析员或设备。可重复性涉及在同一个实验室内，一段较短的时间内，使用相同的分析员和相同的设备的情况下，对分析规程的应用。

Determination---- The precision of an analytical procedure is determined by assaying a sufficient number of aliquots of a homogeneous sample to be able to calculate statistically valid estimates of standard deviation or relative standard deviation (coefficient of variation). Assays in this context are independent analyses of samples that have been carried through the complete analytical procedure from sample preparation to final test result.

测定----分析规程的精密度的测定，通过对充足数量的均质样品的等分试样做含量测定来进行，以便能够计算标准差或相对标准差（变异系数）的具有统计学意义的估计值。在此内容中的含量测定是样品的多次独立分析，其样品已经用完整分析规程（从样品制备到最终检验结果）进行过分析。

The ICH documents recommended that repeatability should be assessed using a minimum of nine determinations covering the specified range for the procedure (i.e., three concentration and three replicates of each concentration or using a minimum of six determinations at 100% of the test concentration).

ICH文件建议可重复性的评估应该使用最少九次检测，覆盖该分析规程所规定的范围（例如，

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