LC-MS

Discussions about HPLC, CE, TLC, SFC, and other "liquid phase" separation techniques.

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For an LC-MS method I am currently running for impurities, we have noted on stability that one of the impurities is now OOS and we have been asked to perform Linearity and get the RRF for this impurity.

What would be the rationale for this?
How do you determine it is out of spec?

Is it calibrated? If so then RRF and Linearity should already be available.

The request would be to prove that it is truly out of spec and not just a calibration/quantification error.
The past is there to guide us into the future, not to dwell in.
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