Beyond-use date: difference between revisions
Diff·revision 45 → 46·05:40, 18 Jul 2025
Difference between revision 45 and revision 46 of Beyond-use date. 10 lines changed; the page grew by 1,447 bytes.
| Revision 45 — 18:36, 10 Jul 2025 CoI_Corin (talk) convert prose to table for comparability 15,718 bytes +350 | Revision 46 — 05:40, 18 Jul 2025 UnitAuditUwe (talk) attribute claim in-text 17,165 bytes +1,447 | ||
|---|---|---|---|
| 106 | The ''shorter-of'' rule then applies. If the lyophilised material carried a manufacturer's expiration date of 30 March, that date governs and the beyond-use date is 30 March, not 9 April, because a preparation cannot outlive the component it was made from. If instead the expiration date were 30 June, the 28-day beyond-use date of 9 April governs. | 106 | The ''shorter-of'' rule then applies. If the lyophilised material carried a manufacturer's expiration date of 30 March, that date governs and the beyond-use date is 30 March, not 9 April, because a preparation cannot outlive the component it was made from. If instead the expiration date were 30 June, the 28-day beyond-use date of 9 April governs. |
| 107 | 107 | ||
| + | 108 | === Where testing is available === | |
| + | 109 | A beyond-use date may be extended beyond the defaults where supported by evidence, and the evidence expected is specific. For chemical stability, a [[Analytical method validation|validated]] stability-indicating assay applied to the actual preparation, in the actual container, at the actual storage temperature, over the proposed period, with the acceptance criterion stated in advance. For sterility, testing under USP <71> on a statistically defensible sample, together with endotoxin testing under USP <85> where relevant.{{r|usp797,usp795}} | |
| + | 110 | ||
| + | 111 | The requirement that the study match the container is the one most often violated in practice, because published stability data are abundant for common combinations and scarce for unusual ones. Sorption of peptide onto container surfaces, permeation of water or oxygen through a polymer wall, and leaching from a closure are all container-specific, and none is detectable in a study performed in a different container.{{r|usp795,usp1191}} | |
| + | 112 | ||
| 108 | == References == | 113 | == References == |
| 109 | {{reflist}} | 114 | {{reflist}} |
| ⋮ | ⋮ | ||
| 117 | <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> | 122 | <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> |
| 118 | 123 | ||
| + | 124 | == Further reading == | |
| + | 125 | * American Society of Health-System Pharmacists. "ASHP Guidelines on Compounding Sterile Preparations." ''American Journal of Health-System Pharmacy'' 71(2):145–166 (2014). | |
| + | 126 | * United States Pharmacopeia, General Chapter <825>, "Radiopharmaceuticals — Preparation, Compounding, Dispensing, and Repackaging" — a parallel dating framework for a different product class. | |
| + | 127 | ||
| 119 | == See also == | 128 | == See also == |
| 120 | * [[Multi-dose vial]] | 129 | * [[Multi-dose vial]] |
| ⋮ | ⋮ | ||
| 124 | * [[Temperature excursion]] | 133 | * [[Temperature excursion]] |
| 125 | * [[Cold chain]] | 134 | * [[Cold chain]] |
| + | 135 | * [[Peptide stability table]] | |
| 126 | 136 | ||
| 127 | {{DEFAULTSORT:Beyond-use date}} | 137 | {{DEFAULTSORT:Beyond-use date}} |