Beyond-use date: difference between revisions
Diff·revision 30 → 31·19:02, 18 Mar 2025
Difference between revision 30 and revision 31 of Beyond-use date. 8 lines changed; the page grew by 1,001 bytes.
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| 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}} | 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 | 82 | ||
| + | 83 | == Opened containers == | |
| + | 84 | Entering a container ends the applicability of its expiration date, because the container closure system on which that date depended has been breached. Dating from that point follows the rules described at [[Multi-dose vial|multiple-dose containers]] and summarised here. | |
| + | 85 | ||
| + | 86 | ; Single-dose containers : Entered in ISO Class 5 air or better, usable for up to 12 hours; entered in poorer air, up to 1 hour. The dependence on air quality reflects that the risk is airborne and personnel-borne contamination at the moment of entry. | |
| + | 87 | ; Multiple-dose containers : 28 days after initial puncture, unless the manufacturer specifies a shorter period. The preservative, not the environment, is what permits the longer period. | |
| + | 88 | ; Pharmacy bulk packages : As stated on the label, conventionally a small number of hours after entry.{{r|usp797,usp659}} | |
| + | 89 | ||
| 83 | == References == | 90 | == References == |
| 84 | {{reflist}} | 91 | {{reflist}} |
| 85 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision, including the beyond-use date tables for Category 1, 2 and 3 preparations.</ref> | 92 | <ref name="usp797">United States Pharmacopeia, General Chapter <797>, "Pharmaceutical Compounding — Sterile Preparations", 2023 revision, including the beyond-use date tables for Category 1, 2 and 3 preparations.</ref> |
| 86 | <ref name="usp795">United States Pharmacopeia, General Chapter <795>, "Pharmaceutical Compounding — Nonsterile Preparations", 2023 revision.</ref> | 93 | <ref name="usp795">United States Pharmacopeia, General Chapter <795>, "Pharmaceutical Compounding — Nonsterile Preparations", 2023 revision.</ref> |
| + | 94 | <ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref> | |
| 87 | <ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</ref> | 95 | <ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</ref> |
| 88 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003), read with ''Q1E: Evaluation for Stability Data'' (2003).</ref> | 96 | <ref name="ich_q1a">International Council for Harmonisation, ''Q1A(R2): Stability Testing of New Drug Substances and Products'' (2003), read with ''Q1E: Evaluation for Stability Data'' (2003).</ref> |