Beyond-use date: difference between revisions
Diff·revision 11 → 12·14:08, 7 Feb 2025
Difference between revision 11 and revision 12 of Beyond-use date. 8 lines changed; the page grew by 688 bytes.
| Revision 11 — 22:23, 25 Jan 2025 eGFR_Esme (talk) add the dead-space volume to the worked example 9,787 bytes +900 | Revision 12 — 14:08, 7 Feb 2025 SyringeSybille (talk) add the sharps-disposal cross-link 10,475 bytes +688 | ||
|---|---|---|---|
| 1 | {{Infobox concept | 1 | {{Infobox concept |
| 2 | | name = Beyond-use date | 2 | | name = Beyond-use date |
| + | 3 | | subtitle = Dating of compounded and opened preparations | |
| 3 | | image = coa-sheet.svg | 4 | | image = coa-sheet.svg |
| 4 | | caption = A beyond-use date is assigned by the person who prepares or opens a preparation, and is recorded on the container rather than derived from it. | 5 | | caption = A beyond-use date is assigned by the person who prepares or opens a preparation, and is recorded on the container rather than derived from it. |
| ⋮ | ⋮ | ||
| 12 | | Container and storage definitions = USP <659> | 13 | | Container and storage definitions = USP <659> |
| 13 | | Stability in dispensing practice = USP <1191> | 14 | | Stability in dispensing practice = USP <1191> |
| + | 15 | <!-- Selected defaults --> | |
| + | 16 | | Multiple-dose container after first puncture = 28 days unless otherwise specified | |
| + | 17 | | Single-dose container entered in ISO Class 5 air = 12 hours | |
| + | 18 | | Single-dose container entered in poorer air = 1 hour | |
| + | 19 | | Nonaqueous nonsterile preparation = 180 days | |
| 14 | }} | 20 | }} |
| 15 | {{hatnote|Not to be confused with the manufacturer expiration date, which is established by a formal stability programme under ICH Q1A(R2).}} | 21 | {{hatnote|Not to be confused with the manufacturer expiration date, which is established by a formal stability programme under ICH Q1A(R2).}} |
| ⋮ | ⋮ | ||
| 59 | 65 | ||
| 60 | Three structural features of the table repay attention. Sterility testing buys a large extension — from 4 days to 30 at room temperature for an aseptically processed preparation from sterile components — which reflects that the untested default is a bound on the probability of undetected contamination rather than an estimate of when contamination occurs. Introducing a nonsterile starting component shortens the dating sharply, because the bioburden and endotoxin history of that component is unknown. And frozen storage flattens the differences, because microbial growth is suppressed and the residual limit becomes chemical.{{r|usp797}} | 66 | Three structural features of the table repay attention. Sterility testing buys a large extension — from 4 days to 30 at room temperature for an aseptically processed preparation from sterile components — which reflects that the untested default is a bound on the probability of undetected contamination rather than an estimate of when contamination occurs. Introducing a nonsterile starting component shortens the dating sharply, because the bioburden and endotoxin history of that component is unknown. And frozen storage flattens the differences, because microbial growth is suppressed and the residual limit becomes chemical.{{r|usp797}} |
| + | 67 | ||
| + | 68 | The chapter states throughout that the defaults are maxima and that a shorter date must be assigned where the chemical or physical stability of the preparation, or the compatibility of its components, requires it. The defaults bound microbiological risk; they say nothing about whether a peptide in the preparation remains intact.{{r|usp797,usp1191}} | |
| 61 | 69 | ||
| 62 | == Nonsterile preparations under USP <795> == | 70 | == Nonsterile preparations under USP <795> == |