Reverse-phase HPLC: difference between revisions
Diff·revision 23 → 24·18:18, 30 Jul 2025
Difference between revision 23 and revision 24 of Reverse-phase HPLC. 3 lines changed; the page grew by 383 bytes.
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| 42 | Two further fields raise a determination substantially. Naming the retention time of the principal peak allows a subsequent determination to be checked for gross discrepancy. Itemising related substances individually, rather than aggregating them, shows how many species were resolved and at what level — which, as discussed at [[Limit of detection]], says as much about the method as about the material. | 42 | Two further fields raise a determination substantially. Naming the retention time of the principal peak allows a subsequent determination to be checked for gross discrepancy. Itemising related substances individually, rather than aggregating them, shows how many species were resolved and at what level — which, as discussed at [[Limit of detection]], says as much about the method as about the material. |
| 43 | 43 | ||
| + | 44 | None of this is a judgement about a supplier. It is a description of which fields make a chromatographic figure checkable, and the criterion applies identically to a supplier certificate and to a [[Third-party testing|third-party]] report.{{r|usp1503,ich_q2}} | |
| + | 45 | ||
| 44 | == References == | 46 | == References == |
| 45 | {{reflist}} | 47 | {{reflist}} |
| ⋮ | ⋮ | ||
| 47 | <ref name="mant1996">Mant CT, Hodges RS. "Analysis of peptides by high-performance liquid chromatography." ''Methods in Enzymology'' 271:3–50 (1996). PMID 8782429.</ref> | 49 | <ref name="mant1996">Mant CT, Hodges RS. "Analysis of peptides by high-performance liquid chromatography." ''Methods in Enzymology'' 271:3–50 (1996). PMID 8782429.</ref> |
| 48 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | 50 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> |
| + | 51 | <ref name="ich_q2">International Council for Harmonisation, ''Q2(R2): Validation of Analytical Procedures'' (2023).</ref> | |
| 49 | 52 | ||
| 50 | == See also == | 53 | == See also == |