Lyophilisation: difference between revisions
Diff·revision 26 → 27·17:20, 5 Jan 2025
Difference between revision 26 and revision 27 of Lyophilisation. 2 lines changed; the page grew by 317 bytes.
| Revision 26 — 13:46, 28 Dec 2024 RepackRadek (talk) typo 13,177 bytes +847 | Revision 27 — 17:20, 5 Jan 2025 UnitsUrsula (talk) rm unsourced claim per PP:V 13,494 bytes +317 | ||
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| 87 | Collapse is not necessarily a chemical failure. A collapsed cake may reconstitute and may assay within specification. Its documented consequences are elevated residual moisture, because the collapsed structure traps water; slower and sometimes incomplete reconstitution; and a cake appearance that fails a visual specification. For proteins, collapse has been associated with reduced storage stability, attributed to increased molecular mobility in the denser matrix.{{r|wang2000}} | 87 | Collapse is not necessarily a chemical failure. A collapsed cake may reconstitute and may assay within specification. Its documented consequences are elevated residual moisture, because the collapsed structure traps water; slower and sometimes incomplete reconstitution; and a cake appearance that fails a visual specification. For proteins, collapse has been associated with reduced storage stability, attributed to increased molecular mobility in the denser matrix.{{r|wang2000}} |
| 88 | 88 | ||
| + | 89 | Conservative practice therefore sets the target product temperature 2–5 °C below Tc and accepts the longer cycle. Aggressive cycles that run within a degree of Tc exist and are defensible when the critical temperature has been measured for the specific formulation rather than assumed from a table.{{r|tang2004}} | |
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| 89 | == References == | 91 | == References == |
| 90 | {{reflist}} | 92 | {{reflist}} |