USP〈1225〉药典规程的验证(中英文对照)(8)

三个浓度和每个浓度三次重复进样，或在100%测试浓度上进行最少六次测定）。

SPECIFITY专属性

Definition---- The ICH documents define specificity as the ability to assess unequivocally the analyt in the presence of components that may be expected to be present, such as impurities, degradation products, and matrix components. Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedures. [NOTE--- Other reputable international authorities (IUPAC, AOAC-I) have preferred the term “selectivity”, reserving “specificity” for those procedures that are completely selective.] For the tests discussed below, the above definition has the following implications.

定义---- ICH文件将专属性定义是当待分析物含有预期会有的其他组分（例如，杂质、降解产物、矩阵组分）时，准确可靠地评估待分析物的能力。某个分析规程缺乏专属性可以通过其他辅助性分析规程进行补偿。【注意：其他声誉卓著的国际权威机构（IUPAC、AOAC-I）已经提出术语“选择性”，而将“专属性”留给已经具有完全选择性的规程。】对于下面讨论的测试，上述定义具有以下的含义。

Identification Tests: ensure the identity of the analyte.

鉴别检测：确保待分析物的鉴别。

Purity Tests: ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte (e.g., related substances test, heavy metals limit, organic volatile impurities).

纯度检测：确保执行的所有分析规程能够令对于待分析物各杂质含量的准确陈述得以做出。

Assays: provide an exact result, which allow an accurate statement on the content or potency of the analyte in a sample.

含量检测：提供准确的结果，令对样品中待分析物的含量或效力的准确陈述得以做出。

Determination---- In the case of qualitative analyses (identification tests), the ability to select

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