Methodological standard · §5
CEI-MS-08 — 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 |
|---|---|---|
| Hydrolysis recovery of the control peptide | 95–105 % of expected amino-acid content | Hydrolysis completeness |
| Hydrolysis-induced racemisation blank, Ser and Thr | Determined and reported, typically 1–4 % | Blank correction validity |
| Resolution between D- and L-derivatives | ≥ 1.5 | Chiral separation adequacy |
| Derivatisation reagent enantiomeric purity | ≥ 99.5 % | Absence of reagent-induced artefact |
§5.2Acceptance criteria
- Corrected D content at any position designed to be L is reported as determined; the Institute sets no universal limit but records that a value above 2 % after blank correction indicates a coupling problem.
- A determination without a reported hydrolysis blank is not reportable, because uncorrected serine and threonine racemisation of several per cent will otherwise be attributed to the synthesis.
- Tryptophan configuration cannot be determined by acid hydrolysis and requires an alternative hydrolysis or an intact-peptide method.
§5.3Limitations
Compound Evidence Institute · CEI-MS-08/5 · https://compoundevidence.com/methods/related-substances/acceptance-criteria/ · retrieved 30 July 2026