Methionine oxidation: difference between revisions
Diff·revision 16 → 17·21:38, 1 Oct 2025
Difference between revision 16 and revision 17 of Methionine oxidation. 3 lines changed; the page grew by 478 bytes.
| Revision 16 — 02:44, 4 Sep 2025 CapitalisationCaz (talk) correct the resolution formula — the denominator is the sum of the widths 4,523 bytes ±0 | Revision 17 — 21:38, 1 Oct 2025 CiteBot (talk) bot: normalise citation format 5,001 bytes +478 | ||
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| 32 | Where a certificate reports only a single aggregate figure for related substances, oxidation state cannot be determined from the document at all. Where it reports intact mass only, an oxidised fraction will not appear unless it is a large proportion, since the unoxidised species will still dominate the spectrum. | 32 | Where a certificate reports only a single aggregate figure for related substances, oxidation state cannot be determined from the document at all. Where it reports intact mass only, an oxidised fraction will not appear unless it is a large proportion, since the unoxidised species will still dominate the spectrum. |
| 33 | 33 | ||
| + | 34 | As with every degradation route, a determination made at release describes the lot at release. Oxidation continues during storage, more slowly in the dry solid than in solution but not at zero rate, which is one of the reasons a [[Beyond-use date|beyond-use date]] and a storage condition accompany a stability statement.{{r|ich_q1a}} | |
| + | 35 | ||
| 34 | == References == | 36 | == References == |
| 35 | {{reflist}} | 37 | {{reflist}} |
| 36 | <ref name="manning2010">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). PMID 20143256.</ref> | 38 | <ref name="manning2010">Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. "Stability of protein pharmaceuticals: an update." ''Pharmaceutical Research'' 27(4):544–575 (2010). PMID 20143256.</ref> |
| 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> |
| + | 40 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> | |
| 38 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> | 41 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> |
| 39 | 42 |