Methodological standard · §5
CEI-MS-05 — 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 |
|---|---|---|
| Standard curve correlation coefficient (absolute value) | ≥ 0.980 | Curve linearity |
| Positive product control recovery | 50–200 % | Absence of interference |
| Negative control | Below the labelled sensitivity | Reagent and water quality |
| Standard curve range | At least a 4-log or as validated | Quantitation range |
§5.2Acceptance criteria
- Endotoxin content must not exceed the limit calculated for the stated intended maximum dose.
- A determination is reportable only where the positive product control recovery falls within 50–200 %.
- A determination without a stated intended dose cannot be assessed against a limit, and the Institute reports it as a concentration with the limit calculation left explicitly open.
§5.3Limitations
Compound Evidence Institute · CEI-MS-05/5 · https://compoundevidence.com/methods/endotoxin-usp85/acceptance-criteria/ · retrieved 30 July 2026