As for national standard drugs , system suitability shall be tested only 對于已有國家標準的藥品,可只檢測系統(tǒng)適用性試驗。
All chromatographic analytical procedures should include system suitability testing and criteria 所有的色譜分析方法都應(yīng)當要有系統(tǒng)適應(yīng)性實驗及相應(yīng)的合格標準。
System suitability testing is recommended as a component of any analytical procedure , not just those that involve chromatographic techniques 建議系統(tǒng)適應(yīng)性實驗應(yīng)成為所有分析方法的一部分,而不僅僅是色譜分析方法。
Parameters typically used in system suitability evaluations are defined and discussed in the cder reviewer guidance on validation of chromatographic methods ( november 1994 ) Cder評審官指南< <色譜分析方法的驗證> > ( 1994年11月)對用于評估系統(tǒng)適應(yīng)性的典型參數(shù)進行了定義和討論。