Beyond-use date: difference between revisions
Diff·revision 48 → 49·18:16, 13 Aug 2025
Difference between revision 48 and revision 49 of Beyond-use date. 4 lines changed; the page grew by 989 bytes.
| Revision 48 — 01:04, 6 Aug 2025 TirzTaxonomist (talk) label community tally as self-reported 17,165 bytes ±0 | Revision 49 — 18:16, 13 Aug 2025 RotationRosalind (talk) fix category — parent was wrong 18,154 bytes +989 | ||
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| 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 | A second worked case illustrates the same rule with a percentage. Under the superseded 25% provision in the older <795>, a preparation made on 12 March from a product expiring on 12 September — 184 days remaining — would have received 25% of 184 days, or 46 days, giving 27 April, since 46 days is less than six months. Under the 2023 revision that calculation is not performed at all and the dosage-form default applies. The two approaches give different answers, which is why the revision status of a cited source matters.{{r|usp795,trissel2022}} | |
| + | 109 | ||
| 108 | === Where testing is available === | 110 | === 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}} | 111 | 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 | 112 | ||
| 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}} | 113 | 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}} |
| + | 114 | ||
| + | 115 | For material distributed outside regulated channels, third-party purity testing of a reconstituted solution after storage is occasionally reported and is a genuine improvement on assertion. Without a matched baseline result on the same lot before storage, however, it cannot distinguish degradation during storage from a purity deficit present at manufacture — the same limitation described at [[Temperature excursion]].{{r|ppbud}} | |
| 112 | 116 | ||
| 113 | == References == | 117 | == References == |