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[求助]
求助HPLC的3
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咨询大家一个问题，对于HPLC，OQ和PQ是不是做的一样的测试，只是IQ在仪器放行前做，PQ在使用时做（如每年做一次），但是测试项目和方法基本上都一样？ 还有，谁能帮我翻译解释一下下面这段话（Agilent的OQ报告中关于梯度比例测试）： This test uses a tracer to determine solvent gradient composition accuracy, stability, and linearity. Accuracy is calculated as the absolute difference between the mean found composition and the nominal step composition. Stability is determined by the noise and drift at each composition step: noise is reported as the Six Sigma value, and drift is the slope of the linear regression in each composition step. Linearity of the gradient control is measured at the start, mid point (checking 50:50 performance), and end of a forced linear gradient and is reported as the coefficient of determination (r2). Other values are reported for information only and require no limits: (1) delay volume; (2) measurements at 0% and 100% reference points; and (3) dwell volume of a fast 0% to 100% gradient step change, an optional evaluation. |
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