Methodological standard · §5
CEI-MS-19 — system suitability and acceptance criteria
The performance the system must demonstrate, and the criteria a result must meet to be reportable.
§5System suitability and acceptance criteria
§5.1System suitability
Table 1. System suitability criteria. A determination is reportable only where every criterion is met at the time of analysis.
| Parameter | Criterion | What it establishes |
|---|---|---|
| Retention factor of the main peak | 2–10 | Adequate interaction with the stationary phase |
| Resolution, main peak to injection disturbance | ≥ 3.0 | Freedom from void interference |
| Resolution, main peak to nearest generated degradant | ≥ 1.5 | Specificity |
| Repeatability of retention time | Relative standard deviation ≤ 1.0 % | Method stability |
§5.2Acceptance criteria
- A purity determination for a poorly retained analyte is reportable only under this standard, with the mechanism and retention factor stated.
- A purity figure for such a compound obtained under CEI-MS-01 conditions is recorded by the Institute as analytically unsupportable, and the Institute notes that such figures are nonetheless in general circulation for several compounds in its monograph series.
§5.3Limitations
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- European Directorate for the Quality of Medicines & HealthCare. General Chapter 2.2.29 Liquid Chromatography. European Pharmacopoeia 2023;11th edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-MS-19/5 · https://compoundevidence.com/methods/poorly-retained/acceptance-criteria/ · retrieved 30 July 2026