Beyond-use date: difference between revisions

Diff·revision 20 → 21·03:43, 22 Jul 2025

Difference between revision 20 and revision 21 of Beyond-use date. 12 lines changed; the page grew by 1,797 bytes.

Revision 20 — 06:15, 3 Jul 2025 A1c_Alder (talk) expand §Sterile preparations under USP <797> 15,368 bytes ±0	Revision 21 — 03:43, 22 Jul 2025 NNT_Nerys (talk) rm the brand-specific instruction; it is not general 17,165 bytes +1,797
104	A lyophilised vial is reconstituted on 12 March and stored refrigerated. A 28-day period gives a beyond-use date of 9 April: the count runs from the day of preparation, and the beyond-use date is the last day on which the preparation may be used, not the first on which it may not — a convention on which sources differ, so that a stated date without a stated convention is ambiguous by a day.	104	A lyophilised vial is reconstituted on 12 March and stored refrigerated. A 28-day period gives a beyond-use date of 9 April: the count runs from the day of preparation, and the beyond-use date is the last day on which the preparation may be used, not the first on which it may not — a convention on which sources differ, so that a stated date without a stated convention is ambiguous by a day.
105		105
+		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
+		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
106	== References ==	113	== References ==
107	{{reflist}}	114	{{reflist}}
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115	<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>
116		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
117	== See also ==	128	== See also ==
118	* [[Multi-dose vial]]	129	* [[Multi-dose vial]]
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122	* [[Temperature excursion]]	133	* [[Temperature excursion]]
123	* [[Cold chain]]	134	* [[Cold chain]]
+		135	* [[Peptide stability table]]
124		136
125	{{DEFAULTSORT:Beyond-use date}}	137	{{DEFAULTSORT:Beyond-use date}}