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Tags · Technique

stability-indicating method

A method that can separate the compound from its degradation products.

20 topics 8 solved Group: Technique

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

TopicParticipantsRepliesViewsActivity
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…
SCVKEC 2 6.8k 21h
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…
MPTIEMHKSL+100 106 35k 2d
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…
CRSOSSSVJW+10 14 15k 3mo
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…
KREHSSNCNA+63 68 2.4k 3mo
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…
VSRLMPMOOB+121 126 1.5k 4mo
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…
KTVPAKAJV+1 5 468 5mo
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…
MSFKJBMRCR+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…
DVEAGTEMNG+5 9 1.1k 6mo
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…
LCMEHMLPFC+28 37 457 7mo
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…
IADCKTFHK+24 28 3.3k 7mo
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…
EFBVPRPOL+53 57 664 8mo
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…
EISFCN 2 43k 8mo
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…
RJAKNKISC+37 41 1.2k 12mo
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.…
LSKAILWNO+119 134 34k 13mo
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…
MCVKSKHVCL+7 11 28k 14mo
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…
MMCCYMRMBJ+109 115 63k 15mo
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…
AAEFNRRBFE+128 148 47k 16mo
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…
FPHETPNNCG+100 112 15k 19mo
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…
OVGBFRSLRM+116 135 42k 19mo
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…
EARFWNFWOO+11 15 21k 21mo