Methodological standard · §5
CEI-MS-14 — 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 |
|---|---|---|
| Critical fields present | All | Conformance |
| Mass balance closure | Within CEI-MS-03 tolerance | Internal consistency |
| Batch code traceable to container | Yes | Attributability |
| Method stated for each determination | Yes | Interpretability |
§5.2Acceptance criteria
- A certificate lacking any critical field is not conformant, irrespective of the quality of the material it describes.
- A purity figure without stated method conditions does not satisfy the purity field.
- An identity claim resting on retention time alone does not satisfy the identity field.
- Conformance of a certificate is a statement about documentation and is never reported by the Institute as a statement about material quality.
§5.3Limitations
Compound Evidence Institute · CEI-MS-14/5 · https://compoundevidence.com/methods/coa-minimum-standard/acceptance-criteria/ · retrieved 30 July 2026