Third-party testing: difference between revisions
Diff·revision 7 → 8·06:23, 3 Sep 2024
Difference between revision 7 and revision 8 of Third-party testing. 7 lines changed; the page grew by 649 bytes.
| Revision 7 — 21:54, 20 Aug 2024 ArchiveBot (talk) bot: add maintenance category 2,764 bytes +38 | Revision 8 — 06:23, 3 Sep 2024 UnitAuditUwe (talk) add the note that a purity figure without water and counterion is not a mass 3,413 bytes +649 | ||
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| 4 | | Commissioned by = The purchaser, not the supplier | 4 | | Commissioned by = The purchaser, not the supplier |
| 5 | | Reported to = The submitter | 5 | | Reported to = The submitter |
| + | 6 | <!-- What it can establish --> | |
| + | 7 | | Identity = If mass or sequence confirmation is included | |
| + | 8 | | Purity of the sample = By [[Area percent purity|area percent]] on the material submitted | |
| + | 9 | | Content = Only if [[Peptide content|content]] is determined | |
| 6 | }} | 10 | }} |
| 7 | 11 | ||
| ⋮ | ⋮ | ||
| 21 | # ''How much active substance is in the vial?'' Answered only by [[Peptide content|peptide content]] together with a water determination and a fill mass. Purity does not answer it. | 25 | # ''How much active substance is in the vial?'' Answered only by [[Peptide content|peptide content]] together with a water determination and a fill mass. Purity does not answer it. |
| 22 | 26 | ||
| + | 27 | A report addressing only the second of these — which many do — leaves the first and third open. A specification is judged by which attributes it covers, not by how favourable the covered ones look.{{r|ich_q6b}} | |
| + | 28 | ||
| 23 | == References == | 29 | == References == |
| 24 | {{reflist}} | 30 | {{reflist}} |
| 25 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 31 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| 26 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 32 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| + | 33 | <ref name="ich_q6b">International Council for Harmonisation, ''Q6B: Specifications — Test Procedures and Acceptance Criteria for Biotechnological/Biological Products'' (1999).</ref> | |
| 27 | 34 | ||
| 28 | {{DEFAULTSORT:Third-party testing}} | 35 | {{DEFAULTSORT:Third-party testing}} |