Tags · Technique
stability-indicating method
A method that can separate the compound from its degradation products.
Related in this group: HPLC · LC-MS · high-resolution MS · MALDI-TOF · UV & DAD detection · peak integration · system suitability · gradient method · water content · amino acid analysis · ELISA · endotoxin testing
20 topics
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Revisiting: Spike-and-recover accuracy for a peptide assay
Revisiting: Spike-and-recover accuracy for a peptide assay — setting out what I have, and where I think it stops being reliable. I was wrong about Spike-and-recover accuracy in a thread last spring and I…
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2 | 6.8k | 21h | |
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Forced degradation studies: designing one that is informative
Posting this under the heading it deserves: Forced degradation studies: designing one that is informative Everything below is what sits behind that. Collecting what is known about forced degradation studies…
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+100 | 106 | 35k | 2d |
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Validating a method you did not develop
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…
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+10 | 14 | 15k | 3mo |
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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…
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+63 | 68 | 2.4k | 3mo |
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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…
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+121 | 126 | 1.5k | 4mo |
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About the Method validation category
Specificity, linearity, precision, accuracy, robustness, system suitability, and why two labs disagree. This post is a community wiki: any member at trust level 3 or above can edit it, and every edit is…
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+1 | 5 | 468 | 5mo |
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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…
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+10 | 14 | 13k | 5mo |
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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…
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+5 | 9 | 1.1k | 6mo |
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Why one laboratory's 98.4% and another's 96.1% may not contradict
Why one laboratory's 98.4% and another's 96.1% may not contradict I have a specific reason for asking rather than idle curiosity, and the context is below. Posting the method first, because I know what the…
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+28 | 37 | 457 | 7mo |
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An inter-laboratory comparison on one lot, tabulated — what changed since
An inter-laboratory comparison on one lot, tabulated — what changed since — setting out what I have, and where I think it stops being reliable. What changes if the standard account of inter-laboratory…
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+24 | 28 | 3.3k | 7mo |
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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…
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+53 | 57 | 664 | 8mo |
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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…
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2 | 43k | 8mo | |
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Forced degradation studies: designing one that is informative — does this still hold?
The question in the title: Forced degradation studies: designing one that is informative — does this still hold? I will give what I have already checked below so nobody repeats it. The question about Forced…
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+37 | 41 | 1.2k | 12mo |
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Repeatability versus intermediate precision
Repeatability versus intermediate precision — setting out what I have, and where I think it stops being reliable. Trying to establish the boundary conditions on repeatability versus intermediate precision.…
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+119 | 134 | 34k | 13mo |
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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…
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+7 | 11 | 28k | 14mo |
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When to suspect the method rather than the sample
When to suspect the method rather than the sample — that is the question, and I have not found it answered plainly anywhere I have looked. Two reports on the same lot, and I would like help deciding whether…
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+109 | 115 | 63k | 15mo |
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Validating a method you did not develop — does this still hold?
Validating a method you did not develop — does this still hold? I have a specific reason for asking rather than idle curiosity, and the context is below. Validating a method, and specifically the version of…
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+128 | 148 | 47k | 16mo |
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What a stability-indicating method is and how you demonstrate one — one year on
What a stability-indicating method is and how you demonstrate one — one year on I have a specific reason for asking rather than idle curiosity, and the context is below. Asking about stability-indicating…
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+100 | 112 | 15k | 19mo |
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Coming back to: When to suspect the method rather than the sample
When to suspect the method rather than the sample I have a specific reason for asking rather than idle curiosity, and the context is below. Two reports on the same lot, and I would like help deciding whether…
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+116 | 135 | 42k | 19mo |
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Relative retention time as a better inter-laboratory comparator — does this still hold?
Relative retention time as a better inter-laboratory comparator — does this still hold? I have a specific reason for asking rather than idle curiosity, and the context is below. What changes if the standard…
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+11 | 15 | 21k | 21mo |