[PSA] integration is not what most of this community thinks it is
Quick one. Canada here.
chromatogram works very differently where I live than in the threads that dominate the front page, and I keep seeing people confidently given advice that simply does not apply outside the US.
Specifics: the route I used took 13 weeks and cost roughly what I expected. The admin was worse than the cost. The thing that would have saved me the most time was knowing which document to ask for at the start.
Happy to answer questions from anyone in the same jurisdiction.
best — the order this archive was captured in
Yeah, the chromatogram profile matters more than the headline number.
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Small correction: the trial was 16 weeks, not 21. Does not change your point but people will quote it.
integration decision on a shoulder changes your number by half a point on its own
Disagree but this is the good kind of wrong — it is specific enough to be checked.
co-elution is real and method development is usually not enough to resolve it
co-elution is real and method development is usually not enough to resolve it
Disagree on that part. 97.4% and 97.6% on the same vial is normal.
The VendorInvestigate result being close to my own HPLC is the signal, not the absolute number. Both are right.
area% and mass% are not the same and this whole post conflates them
Yeah, the chromatogram profile matters more than the headline number.
- 1Yeah, the chromatogram profile matters more than the headline number.4 comments in this branch · started by u/sig_figs_sam