Underfilling: difference between revisions
Diff·revision 18 → 19·12:38, 12 Aug 2025
Difference between revision 18 and revision 19 of Underfilling. 6 lines changed; the page grew by 782 bytes.
| Revision 18 — 21:32, 22 Jul 2025 DisclosureDido (talk) add the point that reports reaching this wiki are not a sample of anything 3,892 bytes +29 | Revision 19 — 12:38, 12 Aug 2025 StubSorterBot (talk) bot: update parent category chain 4,674 bytes +782 | ||
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| 35 | Gravimetry is accessible outside a laboratory. Weighing a sealed vial against an empty vial of the same type gives an approximate fill mass; the approximation is limited by variation in the glass and closure, which for small fills can be comparable with the fill itself. Weighing several units of the same type reduces that error and also reveals vial-to-vial spread, which is often the more informative observation.{{r|reports}} | 35 | Gravimetry is accessible outside a laboratory. Weighing a sealed vial against an empty vial of the same type gives an approximate fill mass; the approximation is limited by variation in the glass and closure, which for small fills can be comparable with the fill itself. Weighing several units of the same type reduces that error and also reveals vial-to-vial spread, which is often the more informative observation.{{r|reports}} |
| 36 | 36 | ||
| + | 37 | == Overage and its interpretation == | |
| + | 38 | Some fills exceed nominal deliberately. A fill target set above the label claim compensates for losses in reconstitution and transfer, and an overage of a few per cent is ordinary in licensed manufacture; it is not a defect.{{r|ich_q7}} | |
| + | 39 | ||
| + | 40 | This cuts against a naive reading of gravimetric results in both directions. A vial weighing more than nominal is not evidence of generosity or of contamination, and a vial weighing slightly less is within ordinary process variation. What is informative is a systematic shortfall across units, or a spread far wider than a fill process should produce. | |
| + | 41 | ||
| 37 | == References == | 42 | == References == |
| 38 | {{reflist}} | 43 | {{reflist}} |
| ⋮ | ⋮ | ||
| 40 | <ref name="usp621">United States Pharmacopeia, General Chapter <621>, ''Chromatography''.</ref> | 45 | <ref name="usp621">United States Pharmacopeia, General Chapter <621>, ''Chromatography''.</ref> |
| 41 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> | 46 | <ref name="reports">PeptidePedia Wiki community test-report tally, 2024–2026 (self-reported; see [[Project:Sourcing_guidelines]]).</ref> |
| + | 47 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | |
| 42 | 48 | ||
| 43 | == See also == | 49 | == See also == |