Methodological standard · §5
CEI-MS-11 — 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 |
|---|---|---|
| Monomer peak asymmetry | 0.8–1.8 | Absence of column interaction |
| Calibration correlation | ≥ 0.99 over the working range | Sizing validity |
| Control-sample monomer content | Within 2 % of its assigned value | System accuracy |
| Recovery, comparing total area to a reverse-phase assay | ≥ 90 % | Absence of irrecoverable adsorption |
§5.2Acceptance criteria
- High-molecular-weight species content is reported as determined. For the amylin analogue class the Institute records any determination as informative and the absence of one as a gap.
- A determination is not reportable where recovery falls below 90 %, because irrecoverably adsorbed material is by definition uncounted.
- A filtered sample must be reported as filtered, and a filtered result may not be described as an aggregate content determination without that qualification.
§5.3Limitations
Compound Evidence Institute · CEI-MS-11/5 · https://compoundevidence.com/methods/aggregates-sec/acceptance-criteria/ · retrieved 30 July 2026