USP〈1225〉药典规程的验证(中英文对照)(12)

with acceptable precision and accuracy under the stated experimental conditions. The quantitation limit is expressed as the concentration of analyte (e.g., percentage, parts per billion) in the sample. 定义---- 定量限度是样品矩阵中低含量物质的定量分析的特性，例如在原料药中的杂质和成品药物中的降解产物。它是在规定试验条件下，能够以可接受的精密度和精确度进行测定的样品中待分析物的最小量。定量限度以样品中待分析物的浓度（例如，百分比、十亿分率）来表示。

Determination---- For non-instrumental procedures, the quantitation limit is generally determined by the analysis of samples with known concentrations of analyte and by establishing the minimum level at which the analyte can be determined with acceptable accuracy and precision.

测定---- 对于非仪器分析规程，定量限度的测定方法通常为对含有已知浓度待分析物的样品进行分析，并确立能够以可接受的准确度和精密度被检测出来的待分析物的最低水平。

For instrumental procedures, the same approach may be used as for non-instrumental procedures. In the case of procedures submitted for consideration as official compendial procedures, it is almost never necessary to determine the actual quantitaion limit. Rather, the quantitation limit is shown to be sufficiently low by the analysis of samples with know concentrations of analyte above and below the quantitation level. For example, if it is required that an analyte be assayed at the level of 0.1 mg per tablet, it should be demonstrated that the procedure will reliably quantitate the analyte at that level.

对于仪器分析规程，可以使用与非仪器分析规程相同的方法。对于提交用于官方药典规程的备选方法，其几乎从来不需要确定实际的检测限度。而是，通过分析含有高于和低于必需的定量水平的、已知待分析物浓度的样品，以显示定量限度足够低。例如，如果必需在0.1mg每片的水平评估待分析物，则应当证明该分析规程将可靠地这个水平定量待分析物。

In the case of instrumental analytical procedures that exhibit background noise, the ICH documents describe a common approach, which is to compare measured signals from samples with known low concentrations of analyte with those of blank samples. The minimum concentration at which the analyte can reliably be quantified is established. A typically acceptable signal-to-noise ratio is 10:1. Other approaches depend on the determination of the slope of the calibration curve and the standard deviation of responses. Whatever method is used, the quantitation limit should be subsequently

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