Methodological standard · §5
CEI-MS-13 — 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 |
|---|---|---|
| Degradation achieved in each stressed sample | 5–20 % | Relevance of the challenge |
| Resolution, analyte to nearest degradant | ≥ 1.5 | Specificity |
| Peak purity angle | Below the purity threshold | Absence of co-elution |
| Mass balance | 95–105 % | Completeness of degradant accounting |
| Accuracy at three levels | 98–102 % recovery | Assay accuracy |
| Repeatability | Relative standard deviation ≤ 2.0 % | Precision |
§5.2Acceptance criteria
- A method is designated stability-indicating only where all criteria are met and the stress conditions were selected from the analyte’s own degradation chemistry.
- A method validated only against a generic stress panel, without regard to the analyte’s labile residues, is not stability-indicating for that analyte.
- A purity or in-use claim supported by a method that is not stability-indicating is recorded by the Institute as unsupported.
§5.3Limitations
Compound Evidence Institute · CEI-MS-13/5 · https://compoundevidence.com/methods/stability-indicating/acceptance-criteria/ · retrieved 30 July 2026