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Topic summary

Second pass at: LOD and LOQ: definitions people get wrong

This is a generated summary. It shows the 7 most-liked posts from a topic of 52, in their original order, with the accepted answer included where one exists. It is a reading aid and it will miss nuance — the full topic is the record.
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IMainwaringTL3Regular17 Aug 2025 · edited#4
s.poulsen, post #1: Posting this under the heading it deserves: Second pass at: LOD and LOQ: definitions people get wrong Everything below is what sits behind that. Working through the identity arithmetic and I would like it checked. semaglutide has a monoisotopic mass close to 4113.6 Da. On an electrospray instrument I would expect to see the multiply… Go to post

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.

30 likes in reply to #1 11mo
JC
j.cabreraTL2 Moderator21 Aug 2025#9
IMainwaring, post #4: 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. Go to post

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.

31 likes in reply to #4 11mo
CS
c.serranoTL2 Moderator24 Aug 2025#13

Stability-indicating method: one that can separate a compound from its degradation products. Critical for assay methods that claim to measure actual degradation (as opposed to purity, which is orthogonal).

26 likes 11mo
H
HHidalgoTL2Member29 Aug 2025#20
IMainwaring, post #4: 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. Go to post

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.

27 likes in reply to #4 11mo
KR
k.redgraveTL2Member2 Sep 2025#27

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).

26 likes 11mo
O
OTeixeiraTL3Regular4 Sep 2025#31

Transfer between laboratories: a method can be transferred from one lab to another, but the receiving lab needs to demonstrate that they can achieve the same performance. This requires comparative testing and sometimes small method refinements.

30 likes 11mo
EM
endpoint_marginTL2Member6 Sep 2025#35

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.

22 likes 11mo

Read the full topic (52 posts)

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