Methodological standard · §5
CEI-MS-01 — 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 |
|---|---|---|
| Theoretical plates for the main peak | ≥ 2000 | Column efficiency |
| Peak symmetry factor (USP tailing) | 0.8 to 2.0 | Peak shape; a tailing factor above 2 for a basic peptide indicates inadequate ion pairing |
| Relative standard deviation of main-peak area, five replicate injections | ≤ 2.0 % | Injection and detection repeatability |
| Resolution between the main peak and the nearest resolved impurity | ≥ 1.5 | Separation adequacy |
| Signal-to-noise ratio at the reporting threshold | ≥ 10 | Quantitation limit |
§5.2Acceptance criteria
- Purity is reported as determined; the Institute sets no universal acceptance limit because an appropriate limit depends on the compound and its intended use.
- A determination is reportable only where all system-suitability criteria are met and the integration start time is stated.
- A determination for a peptide whose main peak elutes with a retention factor below 1.0 is not reportable under this standard; use CEI-MS-19 for poorly retained analytes.
- A purity figure reported without the method conditions in CEI-MS-01 §Apparatus is recorded by the Institute as not conformant.
§5.3Limitations
Compound Evidence Institute · CEI-MS-01/5 · https://compoundevidence.com/methods/rp-hplc-purity/acceptance-criteria/ · retrieved 30 July 2026