Beyond-use date: difference between revisions
Diff·revision 31 → 32·23:44, 25 Mar 2025
Difference between revision 31 and revision 32 of Beyond-use date. 3 lines changed; the page grew by 461 bytes.
| Revision 31 — 19:02, 18 Mar 2025 SyringeSybille (talk) ce 12,094 bytes +1,001 | Revision 32 — 23:44, 25 Mar 2025 Chromatokid (talk) rm maintenance tag, addressed 12,555 bytes +461 | ||
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| 88 | ; Pharmacy bulk packages : As stated on the label, conventionally a small number of hours after entry.{{r|usp797,usp659}} | 88 | ; Pharmacy bulk packages : As stated on the label, conventionally a small number of hours after entry.{{r|usp797,usp659}} |
| 89 | 89 | ||
| + | 90 | The 28-day figure derives from the antimicrobial effectiveness testing in USP <51>, whose challenge protocol runs over 28 days, together with infection-control practice. It is not a chemical stability figure and was never derived as one, a point on which this wiki has had to correct several articles.{{r|usp51,ppbud}} | |
| + | 91 | ||
| 90 | == References == | 92 | == References == |
| 91 | {{reflist}} | 93 | {{reflist}} |
| ⋮ | ⋮ | ||
| 93 | <ref name="usp795">United States Pharmacopeia, General Chapter <795>, "Pharmaceutical Compounding — Nonsterile Preparations", 2023 revision.</ref> | 95 | <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> | 96 | <ref name="usp659">United States Pharmacopeia, General Chapter <659>, "Packaging and Storage Requirements". USP–NF, current revision.</ref> |
| + | 97 | <ref name="usp51">United States Pharmacopeia, General Chapter <51>, "Antimicrobial Effectiveness Testing". 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> | 98 | <ref name="usp1191">United States Pharmacopeia, General Chapter <1191>, "Stability Considerations in Dispensing Practice" (informational). USP–NF, current revision.</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> | 99 | <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> |