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Analytics · Method validation

Repeatability versus intermediate precision — what changed since

DO
dr_okonkwoTL4 Moderator15 Jun 2026#1

Posting this under the heading it deserves: Repeatability versus intermediate precision — what changed since Everything below is what sits behind that.

Working through the identity arithmetic and I would like it checked.

tirzepatide has a monoisotopic mass close to 4813.5 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 (4813.5 + 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.

1 like 1mo
BR
buffer_reviewTL3Regular30 Jun 2026#2

Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing.

The correction was fair and I had been repeating something I had not checked carefully enough.

5 likes 28d
AN
a.norgaardTL2 Moderator10 Jul 2026#3

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).

20 likes 18d
TI
trough_indexTL3Regular19 Jul 2026#4
a.norgaard, post #3: 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). Go to post

Coming back to post #3, because the follow-up matters more than the original answer.

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.

0 likes in reply to #3 9d
FN
f.novakTL2 Moderator28 Jul 2026#5

post #4 is right about the mechanism and I think understates the practical bit.

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.

0 likes 5h

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