USP General Chapter 71: difference between revisions
Diff·revision 1 → 2·08:26, 1 Nov 2024
Difference between revision 1 and revision 2 of USP General Chapter 71. 5 lines changed; the page grew by 559 bytes.
| Revision 1 — 09:00, 30 Oct 2024 TechnicianTeal (talk) create article — method stub 1,155 bytes +1,155 | Revision 2 — 08:26, 1 Nov 2024 Areapercent_Ayo (talk) correct the integration description — valley-to-valley, not drop-line 1,714 bytes +559 | ||
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| 10 | The chapter is explicit that a passing result is not proof of sterility of a batch. Sterility assurance derives from process design and validation; the compendial test is a final check with limited statistical power, and the chapter's companion informational chapter on sterility assurance says so at length.{{r|usp1211}} | 10 | The chapter is explicit that a passing result is not proof of sterility of a batch. Sterility assurance derives from process design and validation; the compendial test is a final check with limited statistical power, and the chapter's companion informational chapter on sterility assurance says so at length.{{r|usp1211}} |
| 11 | 11 | ||
| + | 12 | == What the chapter specifies == | |
| + | 13 | The chapter names two media — fluid thioglycollate medium, incubated at 30–35 °C, and soybean–casein digest medium at 20–25 °C — and requires incubation for not less than fourteen days. It specifies growth-promotion testing of each medium lot against named challenge organisms before use.{{r|usp71}} | |
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| + | 15 | Sample quantities are tabulated by container size and batch size. The number of containers tested is small in absolute terms, which is the source of the statistical limitation discussed at [[Sterility testing]]. | |
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| 12 | == References == | 17 | == References == |
| 13 | {{reflist}} | 18 | {{reflist}} |