Reference standard: difference between revisions
Diff·revision 5 → 6·17:54, 20 Aug 2024
Difference between revision 5 and revision 6 of Reference standard. 3 lines changed; the page grew by 464 bytes.
| Revision 5 — 08:45, 3 Aug 2024 SemaglutideSasha (talk) state the titration endpoint and the reagent factor 1,997 bytes ±0 | Revision 6 — 17:54, 20 Aug 2024 LotTraceLuka (talk) add the note on co-elution and what it hides 2,461 bytes +464 | ||
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| 10 | Standards are described as primary or secondary. A primary standard is characterised by absolute methods without reference to another standard of the same substance; a secondary standard is qualified against a primary one and is what most laboratories actually use. Pharmacopoeial standards are the archetype of the first category.{{r|usp11}} | 10 | Standards are described as primary or secondary. A primary standard is characterised by absolute methods without reference to another standard of the same substance; a secondary standard is qualified against a primary one and is what most laboratories actually use. Pharmacopoeial standards are the archetype of the first category.{{r|usp11}} |
| 11 | 11 | ||
| + | 12 | For compounds without a marketed product there is generally no compendial standard, because compendial standards follow monographs and monographs follow approval. This is a real and under-acknowledged limitation for investigational compounds such as [[Retatrutide|retatrutide]] and [[Survodutide|survodutide]].{{r|usp1503}} | |
| + | 13 | ||
| 12 | == What a standard supplies == | 14 | == What a standard supplies == |
| 13 | A reference standard carries more than the substance. Its accompanying documentation states the assigned content — the mass fraction that is the substance of interest, which is not 100% — the identity data supporting the assignment, the storage conditions, and a retest or expiry date.{{r|usp11}} | 15 | A reference standard carries more than the substance. Its accompanying documentation states the assigned content — the mass fraction that is the substance of interest, which is not 100% — the identity data supporting the assignment, the storage conditions, and a retest or expiry date.{{r|usp11}} |
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| 18 | {{reflist}} | 20 | {{reflist}} |
| 19 | <ref name="usp11">United States Pharmacopeia, General Chapter <11>, ''USP Reference Standards''.</ref> | 21 | <ref name="usp11">United States Pharmacopeia, General Chapter <11>, ''USP Reference Standards''.</ref> |
| + | 22 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 20 | 23 | ||
| 21 | {{DEFAULTSORT:Reference standard}} | 24 | {{DEFAULTSORT:Reference standard}} |