Topic summary

Validating a method you did not develop

Analytics › Method validation precision & repeatability recovery linearity stability-indicating method system suitability

This is a generated summary. It shows the 5 most-liked posts from a topic of 15, 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.

steady_stateTL3Regular30 Sep 2025#3

c.ramos, post #1: On the subject in the title: Validating a method you did not develop Working notes rather than a conclusion. What changes if the standard account of validating a method is wrong? I ask because I have been treating it as settled and I noticed this week that I could not say why. Working through the consequences rather than the evidence,… Go to post

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.

This has been discussed before and I could not find the thread, so, again.

20 likes in reply to #1 10mo

b.kowalskiTL27 Jan 2026 · edited#8

n.cabrera, post #6: On post #4 — agreed on the reasoning, with one qualification. Robustness testing deliberately varies the parameters most likely to drift — organic percentage, pH, temperature, flow — and shows the result does not. It is the part of validation that predicts whether a method will transfer. Go to post

A method transferred between laboratories needs a demonstration that it performs equivalently, not just a document describing it. Transfer is where a great many between-laboratory disagreements originate.

Adding a source would improve this post and I do not have one to hand.

29 likes in reply to #6 7mo

r.laurentTL227 Feb 2026#11

Post #8 put the caveat in the right place and I want to underline it.

A stability-indicating method is one demonstrated to resolve the analyte from its degradation products, usually through forced degradation. Calling a method stability-indicating without that work is a claim rather than a property.

If anyone has run this properly I would rather read that than my own guess.

10 likes 5mo

mira.patelTL4 Admin15 Apr 2026#14

An independent laboratory's method being different from the supplier's is not a discrepancy. It becomes one only when the results differ by more than both methods' demonstrated precision.

23 likes 3mo

d.bakkerTL21 May 2026#15

c.boateng, post #13: That reframing is the whole thing. The facts I already had. Go to post

Where I part company with post #11, and it is a narrow parting.

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).

16 likes in reply to #13 3mo

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This topic was referenced in

An inter-laboratory comparison on one lot, tabulatedAnalytics › Method validation · 3 replies
Validating a method you did not develop — does this still hold?Analytics › Method validation · 148 replies

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