Repackaging: difference between revisions
Diff·revision 8 → 9·08:38, 22 Dec 2024
Difference between revision 8 and revision 9 of Repackaging. 5 lines changed; the page grew by 654 bytes.
| Revision 8 — 18:46, 5 Dec 2024 SPPS_Sorrel (talk) add category for logistics 2,904 bytes ±0 | Revision 9 — 08:38, 22 Dec 2024 FmocFrancis (talk) attribute the stability figure to the study and its duration 3,558 bytes +654 | ||
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| 26 | This is why the observable indicators described at [[Lot traceability]] — identifier agreement across vial, certificate and paperwork, and retrievability of a certificate for an older lot — are the practical tests available to a purchaser.{{r|reports}} | 26 | This is why the observable indicators described at [[Lot traceability]] — identifier agreement across vial, certificate and paperwork, and retrievability of a certificate for an older lot — are the practical tests available to a purchaser.{{r|reports}} |
| 27 | 27 | ||
| + | 28 | == Environmental exposure during transfer == | |
| + | 29 | Opening a container exposes its contents to atmospheric moisture and oxygen. Lyophilised peptides are hygroscopic, so water content rises measurably during any open handling, and a repackaged material may carry a higher water content than the certificate for the original lot reported. See [[Loss on drying]].{{r|usp1503}} | |
| + | 30 | ||
| + | 31 | Container and closure differ too. Stability data are generated in a specific container-closure system, and transferring material to a different one invalidates the direct applicability of those data — a technical point rather than a legal one for material outside regulated supply. | |
| + | 32 | ||
| 28 | == References == | 33 | == References == |
| 29 | {{reflist}} | 34 | {{reflist}} |