The limit of quantitation determines what the impurity table can honestly contain. Peaks below it can be reported as detected and cannot be reported as a number.
I have kept the units in throughout, for the obvious reason.
Topic summary
Why one laboratory's 98.4% and another's 96.1% may not contradict
This is a generated summary. It shows the 5 most-liked posts from a topic of 38, 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.
I read post #5 twice before replying, because I had assumed the opposite.
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).
31 likes 14mo
Everything in post #12 holds. The case it does not cover is the one I have.
Range and working range are different things and a certificate rarely distinguishes them. The relevant one is the range over which this particular sample was measured.
26 likes 12mo
The most useful single question about a method: what would it fail to detect? Every method has an answer and few documents state it.
29 likes 9mo
Read the full topic (38 posts)
This topic was referenced in
- Specificity, linearity, accuracy, precision, range, robustness — with real criteriaAnalytics › Method validation · 48 replies
- Forced degradation studies: designing one that is informativeAnalytics › Method validation · 106 replies
Suggested topics
| Topic | Participants | Replies | Views | Activity |
|---|---|---|---|---|
|
Relative retention time as a better inter-laboratory comparator
On the subject in the title: Relative retention time as a better inter-laboratory comparator Working notes rather than a conclusion. What changes if the standard account of relative retention time is wrong? I…
|
+7 | 11 | 28k | 14mo |
|
Spike-and-recover accuracy for a peptide assay
Posting this under the heading it deserves: Spike-and-recover accuracy for a peptide assay Everything below is what sits behind that. Asking about spike-and-recover accuracy on behalf of the question I keep…
|
+121 | 126 | 1.5k | 4mo |
|
Sample handling between despatch and injection
Sample handling between despatch and injection Writing it up because I had to work it out twice and would rather nobody else did. Trying to work out what would count as evidence on sample handling between…
|
+63 | 68 | 2.4k | 3mo |
|
Why one laboratory's 98.4% and another's 96.1% may not contradict — one year on
Asking directly, because I could not find a straight answer: Why one laboratory's 98.4% and another's 96.1% may not contradict — one year on Posting the method first, because I know what the first three…
|
+10 | 14 | 13k | 5mo |
|
Revisiting: Sample handling between despatch and injection
Posting this under the heading it deserves: Revisiting: Sample handling between despatch and injection Everything below is what sits behind that. Reading back through what has been written here about Sample…
|
+5 | 9 | 1.1k | 6mo |
Related topics — sharing the tags stability-indicating method, LOD & LOQ, linearity
| Topic | Participants | Replies | Views | Activity |
|---|---|---|---|---|
|
LOD and LOQ: definitions people get wrong
LOD and LOQ: definitions people get wrong — setting out what I have, and where I think it stops being reliable. What changes if the standard account of LOD and LOQ is wrong? I ask because I have been treating…
|
2 | 43k | 8mo | |
|
Specificity, linearity, accuracy, precision, range, robustness — with real criteria
Specificity, linearity, accuracy, precision, range, robustness — with real criteria Writing it up because I had to work it out twice and would rather nobody else did. Trying to establish the boundary…
|
+44 | 48 | 12k | 1d |
|
Spike-and-recover accuracy for a peptide assay
Posting this under the heading it deserves: Spike-and-recover accuracy for a peptide assay Everything below is what sits behind that. Asking about spike-and-recover accuracy on behalf of the question I keep…
|
+121 | 126 | 1.5k | 4mo |
|
Robustness: the parameters worth deliberately varying
Robustness: the parameters worth deliberately varying Writing it up because I had to work it out twice and would rather nobody else did. A narrow question about robustness, deliberately narrow, because the…
|
+53 | 57 | 664 | 8mo |
|
An inter-laboratory comparison on one lot, tabulated
On the subject in the title: An inter-laboratory comparison on one lot, tabulated Working notes rather than a conclusion. Collecting what is known about inter-laboratory comparison in one place, because it is…
|
3 | 17k | 10mo |