USP〈1225〉药典规程的验证(中英文对照)(5)

the accuracy of which has been stated or defined.

测定---- 对于原料药的含量测定，可以用该分析规程来分析已知纯度的被分析物（例如，某个标准物质），或将以此规程所得的结果与第二种、成熟的、已知准确度的规程所得的结果进行比较，以测定其精确性。

In the case of the assay of a drug in a formulated product, accuracy may be determined by application of the analytical procedure to synthetic mixtures of the drug product components to which known amounts of analyte have been added within the range of the procedure. If it is not possible to obtain samples of all drug product components, it may be acceptable either to add known quantities of the analyte to the drug product (i.e., “to spike”) or to compare results with those of a second, well-characterized procedure, the accuracy of which has been stated or defined.

对于处方产品中某个药物的含量测定，以该分析规程来分析成药各组分的合成混合物，其中已经在这些组分的范围之内加入已知数量的待分析物。如果不可能得到成药的所有组分，也可以将已知数量的待分析物加入到该成药中（例如，“增敏”），或者将结果与用第二种、成熟的、已知准确度的规程得到的结果进行比较，

In the case of quantitative analysis of impurities, accuracy should be assessed on samples (of drug substance or drug product) spiked with known amount of impurities. Where it is not possible to obtain samples of certain impurities or degradation products, results should be compared with those obtained by an independent procedure. In the absence of other information, it may necessary to calculate the amount of an impurity based on comparison of its response to that of the drug substance; the ratio of the response of equal amounts of the impurity and the drug substance (relative response factor) should be used if known.

对于杂质的定量分析，应使用以已知数量杂质增敏的样品来评估准确度。当不可能获得特定杂质或降解产物的样品时，应将结果与得自独立规程的的结果进行比较。在没有其他信息的情况下，可能必需通过将某种杂质的响应值与药物的响应值进行比较来计算杂质的数量；同等数量的杂质与药物的响应值的比值（相对响应因子），如果已知，则应使用。

Accuracy is calculated as the percentage of recovery by the assay of the known added amount of analyte in the sample, or as the difference between the mean and the accepted true value, together

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