Purity claim inflation: difference between revisions
Diff·revision 14 → 15·04:41, 28 Mar 2025
Difference between revision 14 and revision 15 of Purity claim inflation. 5 lines changed; the page grew by 872 bytes.
| Revision 14 — 22:07, 9 Mar 2025 UnderfillUna (talk) add the note that self-submitted reports are a self-selected sample 3,723 bytes +120 | Revision 15 — 04:41, 28 Mar 2025 ForgeryFinder (talk) expand §Reading against inflation 4,595 bytes +872 | ||
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| 33 | What it does not establish: how much peptide is in the vial; that the main peak is the intended molecule; that undetected species are absent; that the figure would be reproduced on a different method. | 33 | What it does not establish: how much peptide is in the vial; that the main peak is the intended molecule; that undetected species are absent; that the figure would be reproduced on a different method. |
| 34 | 34 | ||
| + | 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 | ||
| 35 | == References == | 37 | == References == |
| 36 | {{reflist}} | 38 | {{reflist}} |
| 37 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 39 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 38 | <ref name="usp621">United States Pharmacopeia, General Chapter <621>, ''Chromatography''.</ref> | 40 | <ref name="usp621">United States Pharmacopeia, General Chapter <621>, ''Chromatography''.</ref> |
| + | 41 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | |
| + | 42 | <ref name="ich_q6b">International Council for Harmonisation, ''Q6B: Specifications — Test Procedures and Acceptance Criteria for Biotechnological/Biological Products'' (1999).</ref> | |
| 39 | 43 | ||
| 40 | == See also == | 44 | == See also == |
| ⋮ | ⋮ | ||
| 43 | * [[Certificate of analysis]] | 47 | * [[Certificate of analysis]] |
| 44 | * [[Test report forgery]] | 48 | * [[Test report forgery]] |
| + | 49 | * [[Analytical method validation]] | |
| 45 | 50 | ||
| 46 | {{DEFAULTSORT:Purity claim inflation}} | 51 | {{DEFAULTSORT:Purity claim inflation}} |