USP〈1225〉药典规程的验证(中英文对照)(10)

如果没有杂质或降解产物的标准品，可以通过将含有杂质或降解产物的样品的测试结果与第二种、成熟规程（例如，药典或其他验证过的规程）的结果进行比较，来论证专属性。这些比较应该包括在相关破坏性条件下（例如，光、热、湿度、酸/碱水解、氧化作用）存储的样品。对于含量测定，应比较其结果；对于色谱法杂质检测，应比较杂质概况。

The ICH documents state that when chromatographic procedures are used, representative chromatograms should be presented to demonstrate the degree of selectivity, and peaks should be appropriately labeled. Peak purity tests (e.g., using diode array or mass spectrometry) may be useful to show that the analyte chromatographic peak is not attributable to more than one component.

ICH文件声明，当使用色谱分析规程时，应提交具代表性的色谱图，以论证选择性的程度，而且应对色谱峰作适当的标识。也可以使用色谱峰纯度测试（例如，使用二极管阵列或质谱仪），来显示待分析物的色谱峰仅产生于一个组分。

DETECTION LIMIT检测限度

Definition---- The detection limit is a characteristic of limit tests. It is the lowest amount of analyte in a sample that can be detected, but not necessarily quantitated, under the stated experimental conditions. Thus, limit tests merely substantiate that the amount of analyte is above or below a certain level. The detection limit is usually expressed as the concentration of analyte (e.g., percentage, parts per billion) in the sample.

定义---- 检测限度是限度检测的特性。它是指在规定的试验条件下，样品中可被检测到的待分析物的最小数量，但是无需定量。因此，限度检测仅仅说明了待分析物的数量高于或低于某个特定水平。检测限度通常以在样品中的待分析物浓度（例如，百分比、十亿分率）表示。

Determination---- For non-instrumental procedures, the detection 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 reliably detected.

测定---- 对于非仪器分析规程，检测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，并确立能够可靠地被检测出来的待分析物的最低水平。

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