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Certificate of analysis: difference between revisions

Diff·revision 21 → 22·18:48, 28 Apr 2025

Difference between revision 21 and revision 22 of Certificate of analysis. 8 lines changed; the page grew by 583 bytes.

Revision 21 — 10:29, 9 Apr 2025
PancreasPru (talk)
state that the sample was not drawn blind, so it represents the vial and not the lot
7,513 bytes +541
Revision 22 — 18:48, 28 Apr 2025
CategoryBot (talk)
bot: update parent category chain
8,096 bytes +583
53Disagreement is equally easy to over-read. Two laboratories running different gradients on different column chemistries, integrating valley-to-valley rather than by drop-line, and calibrating against different [[Reference standard|reference standards]], will produce different numbers for the same vial and both may be honest. This is why the '''method''' field matters more than its position on the page suggests: without it, a comparison between a certificate and a report is a comparison between two unspecified procedures.{{r|usp1503}}53Disagreement is equally easy to over-read. Two laboratories running different gradients on different column chemistries, integrating valley-to-valley rather than by drop-line, and calibrating against different [[Reference standard|reference standards]], will produce different numbers for the same vial and both may be honest. This is why the '''method''' field matters more than its position on the page suggests: without it, a comparison between a certificate and a report is a comparison between two unspecified procedures.{{r|usp1503}}
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+55=== What to request beyond the certificate ===
+56A purchaser wanting a certificate figure to be comparable with an independently obtained one needs four further items, all of which exist in the issuer's records whether or not they appear on the document:
+57
+58# the gradient and column chemistry the determination was run on;
+59# the detection wavelength, since ultraviolet response is not uniform across impurities;
+60# the water determination, with the method that produced it;
+61# the [[Peptide content|peptide content]], or the counterion identity and content from which it can be derived.
+62
55== References ==63== References ==
56{{reflist}}64{{reflist}}