Beyond-use date: difference between revisions
Diff·revision 12 → 13·12:54, 25 Feb 2025
Difference between revision 12 and revision 13 of Beyond-use date. 9 lines changed; the page grew by 618 bytes.
| Revision 12 — 14:08, 7 Feb 2025 SyringeSybille (talk) add the sharps-disposal cross-link 10,475 bytes +688 | Revision 13 — 12:54, 25 Feb 2025 SharpsSukhi (talk) add a second worked example at a different vial strength 11,093 bytes +618 | ||
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| 79 | Periods are those in the 2023 revision.{{r|usp795}} The revision removed a widely known earlier provision under which a preparation made from a manufactured product could be assigned a beyond-use date of not later than 25% of the time remaining until that product's expiration date, or six months, whichever was earlier. That ''25% rule'' remains in circulation in secondary sources and in older references, and is no longer the compendial position; sources quoting it should be checked against the current revision.{{r|usp795,trissel2022}} | 79 | Periods are those in the 2023 revision.{{r|usp795}} The revision removed a widely known earlier provision under which a preparation made from a manufactured product could be assigned a beyond-use date of not later than 25% of the time remaining until that product's expiration date, or six months, whichever was earlier. That ''25% rule'' remains in circulation in secondary sources and in older references, and is no longer the compendial position; sources quoting it should be checked against the current revision.{{r|usp795,trissel2022}} |
| 80 | 80 | ||
| + | 81 | The 2023 chapter also permits longer dating where supported by a stability-indicating study on the preparation, or by published stability information for the same formulation in the same container and storage condition. The qualification about container and condition is not incidental: published stability data for a solution in a glass vial does not transfer to the same solution in a plastic syringe, because sorption and permeation differ.{{r|usp795,trissel2022}} | |
| + | 82 | ||
| 81 | == References == | 83 | == References == |
| 82 | {{reflist}} | 84 | {{reflist}} |
| ⋮ | ⋮ | ||
| 87 | <ref name="trissel2022">Trissel LA. ''Handbook on Injectable Drugs''. 21st edition, American Society of Health-System Pharmacists (2022). The standard compilation of published stability and compatibility data.</ref> | 89 | <ref name="trissel2022">Trissel LA. ''Handbook on Injectable Drugs''. 21st edition, American Society of Health-System Pharmacists (2022). The standard compilation of published stability and compatibility data.</ref> |
| 88 | <ref name="ppbud">PeptidePedia community dating-practice tally and the 2026 request for comment on dating terminology (self-reported practice; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> | 90 | <ref name="ppbud">PeptidePedia community dating-practice tally and the 2026 request for comment on dating terminology (self-reported practice; weak evidence — see [[Project:Sourcing_guidelines]]).</ref> |
| + | 91 | ||
| + | 92 | == See also == | |
| + | 93 | * [[Multi-dose vial]] | |
| + | 94 | * [[Vial]] | |
| + | 95 | * [[Bacteriostatic water]] | |
| + | 96 | * [[Reconstitution of lyophilised peptides]] | |
| + | 97 | * [[Temperature excursion]] | |
| 89 | 98 | ||
| 90 | {{DEFAULTSORT:Beyond-use date}} | 99 | {{DEFAULTSORT:Beyond-use date}} |