Precision and repeatability: within-run and between-run variability of the method. Acceptance criterion is typically a relative standard deviation of ≤2% for area measurements.
Second pass at: LOD and LOQ: definitions people get wrong
Why two laboratories may disagree: after validating the same method, they may still report different purity on the same sample due to integration differences, column age differences, subtle differences in mobile phase pH or temperature. This is normal and not a sign that one is wrong.
Linearity: the detector response is proportional to compound concentration across the working range. Demonstrated by running standards at multiple concentrations and showing R-squared values typically ≥0.99.
post #26 answers the question as asked. The question underneath it is different.
System suitability: injections run at the start of a batch to establish that the instrument and column are performing. Acceptance criteria typically include replicate precision (RSD ≤2%), peak tailing (0.8–1.5), theoretical plates (>2000), and resolution (>1.5).
On post #31 — agreed on the reasoning, with one qualification.
Forced degradation studies: deliberately stress the material with acid, base, oxidant, heat, light to generate degradation products and demonstrate that the method can separate them from the parent peak. Acceptance is that the method is stability-indicating.
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- When to suspect the method rather than the sampleAnalytics › Method validation · 115 replies
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