Peptide content: difference between revisions
Diff·revision 3 → 4·08:38, 1 Oct 2024
Difference between revision 3 and revision 4 of Peptide content. 3 lines changed; the page grew by 574 bytes.
| Revision 3 — 17:34, 15 Sep 2024 AnalyticalAnnie (talk) clarify that area percent is not mass percent 1,955 bytes +682 | Revision 4 — 08:38, 1 Oct 2024 StubSorterBot (talk) bot: flag bare reference 2,529 bytes +574 | ||
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| 17 | | Peptide-related impurities | 0.5–3% | The complement of [[Area percent purity]] | | 17 | | Peptide-related impurities | 0.5–3% | The complement of [[Area percent purity]] | |
| 18 | 18 | ||
| + | 19 | The acetonitrile carried over from preparative purification is the residual solvent that dominates in practice; it is classified for toxicity and given a concentration limit under the harmonised residual-solvent guideline, and it is determined by headspace gas chromatography rather than inferred.{{r|ichq3c}} | |
| + | 20 | ||
| 19 | == References == | 21 | == References == |
| 20 | {{reflist}} | 22 | {{reflist}} |
| 21 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision. Sets out peptide content as an attribute distinct from chromatographic purity.</ref> | 23 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, "Quality Attributes of Synthetic Peptide Drug Substances" (informational). USP–NF, current revision. Sets out peptide content as an attribute distinct from chromatographic purity.</ref> |
| + | 24 | <ref name="ichq3c">International Council for Harmonisation, ''Q3C: Impurities — Guideline for Residual Solvents''. Classifies solvents by toxicity and sets concentration limits; the acetonitrile used in preparative purification falls in the second class.</ref> | |
| 22 | 25 | ||
| 23 | {{DEFAULTSORT:Peptide content}} | 26 | {{DEFAULTSORT:Peptide content}} |