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Analytics · Method validation

An inter-laboratory comparison on one lot, tabulated

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ZA
z.adeyemiTL2 Moderator18 Sep 2025#1

On the subject in the title: An inter-laboratory comparison on one lot, tabulated Working notes rather than a conclusion.

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 charged series rather than the intact singly charged ion, so for the doubly charged species I calculate (4113.6 + 2 x 1.00728) / 2, and for the triply charged the analogous expression.

The observed values in the report sit within a few ppm of those. My question is what that actually establishes, because I have seen people treat a mass match as a purity result and I do not think it is one.

40 likes 10mo
MG
m.guerreroTL2 Moderator27 Sep 2025#2

I read the opening post twice before replying, because I had assumed the opposite.

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.

0 likes 10mo
CR
crossover_reviewTL3Regular3 Oct 2025#3

For anyone arriving from a search: the marked solution above is the direct answer, and the replies underneath it add the caveats that make it safe to use.

1 like 10mo
KB
k.batistaTL2 Moderator8 Oct 2025#4

Robustness: the method gives consistent results when minor parameters vary. Tested by deliberately varying pH, temperature, flow rate, and mobile phase composition within reasonable ranges and demonstrating that results stay within acceptance.

6 likes 10mo
Promoted into the documentation commons. The content of this topic is maintained at Forced degradation and stability-indicating methods, with named maintainers and a review date. The promotion was discussed in doc review. Corrections are best raised against the document, which is the version that gets kept current.
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