Purity claim inflation: difference between revisions
Diff·revision 19 → 20·12:18, 19 Jun 2025
Difference between revision 19 and revision 20 of Purity claim inflation. 5 lines changed; the page grew by 561 bytes.
| Revision 19 — 10:41, 30 May 2025 LotTraceLuka (talk) state that the sample was not drawn blind, so it represents the vial and not the lot 4,595 bytes ±0 | Revision 20 — 12:18, 19 Jun 2025 A1c_Alder (talk) convert the service comparison to a table 5,156 bytes +561 | ||
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| 35 | A complete characterisation therefore requires, at minimum, identity by [[Mass spectrometry|mass]], purity by a specified chromatographic method, [[Peptide content|content]], and water. Certificates supplying all four are a minority in submissions to this wiki, though all four are ordinary components of a specification where one exists.{{r|ich_q6b}} A certificate supplying only the second is not thereby dishonest — but a claim about how much active substance a vial contains cannot rest on it.{{r|reports}} | 35 | A complete characterisation therefore requires, at minimum, identity by [[Mass spectrometry|mass]], purity by a specified chromatographic method, [[Peptide content|content]], and water. Certificates supplying all four are a minority in submissions to this wiki, though all four are ordinary components of a specification where one exists.{{r|ich_q6b}} A certificate supplying only the second is not thereby dishonest — but a claim about how much active substance a vial contains cannot rest on it.{{r|reports}} |
| 36 | 36 | ||
| + | 37 | == Reading against inflation == | |
| + | 38 | The useful questions are about method rather than about number, and are answerable from a well-constructed certificate. | |
| + | 39 | ||
| + | 40 | Which method produced the figure, at what wavelength, on what column, over what gradient duration? Is the main peak identified, and by what? Is [[Peptide content|content]] reported separately from purity? Are related substances itemised or aggregated? Is water reported, and by [[Karl Fischer titration|Karl Fischer]] or by [[Loss on drying|loss on drying]] — which measure different things?{{r|usp1503}} | |
| + | 41 | ||
| 37 | == References == | 42 | == References == |
| 38 | {{reflist}} | 43 | {{reflist}} |