Counterfeit peptide: difference between revisions
Diff·revision 11 → 12·08:21, 22 Mar 2025
Difference between revision 11 and revision 12 of Counterfeit peptide. 4 lines changed; the page grew by 535 bytes.
| Revision 11 — 01:24, 7 Mar 2025 ShortDescShai (talk) state the method the reporting service uses, since it is not the only one available 3,343 bytes +610 | Revision 12 — 08:21, 22 Mar 2025 NAION_Noel (talk) British spelling per PP:MOS 3,878 bytes +535 | ||
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| 1 | {{Infobox concept | 1 | {{Infobox concept |
| 2 | | name = Counterfeit peptide | 2 | | name = Counterfeit peptide |
| + | 3 | | subtitle = Supply chain integrity | |
| 3 | | Substitution = A different, usually cheaper, compound | 4 | | Substitution = A different, usually cheaper, compound |
| 4 | | Dilution = The correct compound with undeclared bulking agent | 5 | | Dilution = The correct compound with undeclared bulking agent |
| ⋮ | ⋮ | ||
| 25 | Chromatographic purity does not detect it. A sugar does not absorb appreciably at 214 nm and will not appear in the chromatogram; the purity figure is computed over what was detected, and the bulking agent is not part of it. The determination that detects dilution is [[Peptide content|peptide content]], which measures the mass fraction of the solid that is peptide. | 26 | Chromatographic purity does not detect it. A sugar does not absorb appreciably at 214 nm and will not appear in the chromatogram; the purity figure is computed over what was detected, and the bulking agent is not part of it. The determination that detects dilution is [[Peptide content|peptide content]], which measures the mass fraction of the solid that is peptide. |
| 26 | 27 | ||
| + | 28 | Some legitimate lyophilised products contain excipients by design, as bulking agents or cryoprotectants, and a declared excipient is not a counterfeit. The distinction is disclosure: an excipient stated on the label and accounted for in the content figure is a formulation choice, and one that is neither is a misrepresentation.{{r|ich_q7}} | |
| + | 29 | ||
| 27 | == References == | 30 | == References == |
| 28 | {{reflist}} | 31 | {{reflist}} |
| 29 | <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> |
| 30 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 33 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 34 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | |
| 31 | 35 | ||
| 32 | {{DEFAULTSORT:Counterfeit peptide}} | 36 | {{DEFAULTSORT:Counterfeit peptide}} |