...(validation),但这并未能代表对具体试 验中操作情况的评估,因此药品标准中通常 用系统适用性试验(System suitability tests, SST)来评估对具体分析过程的执行情况。
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对于已有国家标准的药品,可只检测系统适用性试验。
As for national standard drugs, system suitability shall be tested only.
其中,分离度和重复性是系统适用性试验中更具实用意义的参数。
Among which, separating degree and repeatability are more practical parameters in system applicability test.
系统适用性试验可评估峰形、溶剂干扰、主峰相邻峰的分离和进样精密度。
System suitability tests may evaluate peak shape; separation of themain peak from solvent disturbance and from closely eluting peaks; andinjection precision.
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