Loss on drying: difference between revisions
Diff·revision 20 → 21·14:00, 6 Aug 2025
Difference between revision 20 and revision 21 of Loss on drying. 3 lines changed; the page grew by 493 bytes.
| Revision 20 — 10:33, 14 Jul 2025 GroupBuyGalen (talk) add the counterion determination method by name 4,381 bytes ±0 | Revision 21 — 14:00, 6 Aug 2025 CiteBot (talk) bot: sort category members 4,874 bytes +493 | ||
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| 38 | A very low figure on a hygroscopic peptide is worth as much attention as a high one, since it implies either aggressive drying or a handling regime a purchaser cannot reproduce. Once a vial is opened in ambient air, water content begins to rise regardless of what the certificate said. | 38 | A very low figure on a hygroscopic peptide is worth as much attention as a high one, since it implies either aggressive drying or a handling regime a purchaser cannot reproduce. Once a vial is opened in ambient air, water content begins to rise regardless of what the certificate said. |
| 39 | 39 | ||
| + | 40 | The practical consequence for anyone reconstituting material is that the certificate's water figure describes the lot as tested, not the vial as received, and a stability statement is written against a storage condition rather than against a vial's history. See [[Reconstitution of lyophilised peptides]] and [[Beyond-use date]].{{r|usp731,ich_q1a}} | |
| + | 41 | ||
| 40 | == References == | 42 | == References == |
| 41 | {{reflist}} | 43 | {{reflist}} |
| ⋮ | ⋮ | ||
| 43 | <ref name="usp921">United States Pharmacopeia, General Chapter <921>, ''Water Determination''.</ref> | 45 | <ref name="usp921">United States Pharmacopeia, General Chapter <921>, ''Water Determination''.</ref> |
| 44 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 46 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 47 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003).</ref> | |
| 45 | 48 | ||
| 46 | == See also == | 49 | == See also == |