Methodological standard · §5
CEI-MS-07 — 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 |
|---|---|---|
| Particle-standard recovery | Within stated tolerance | Counter calibration |
| Blank count | < 10 % of the acceptance limit | Diluent and glassware cleanliness |
| Aliquots counted | ≥ 4, first discarded | Flush of the sensing zone |
| Relative standard deviation between aliquots | ≤ 15 % | Homogeneity and absence of bubbles |
§5.2Acceptance criteria
- For small-volume parenterals the limits are 6000 particles ≥ 10 µm and 600 particles ≥ 25 µm per container.
- A count obtained on an agitated or freshly shaken sample is not reportable.
- A visibly particulate reconstituted solution fails on inspection and no count is required.
§5.3Limitations
Compound Evidence Institute · CEI-MS-07/5 · https://compoundevidence.com/methods/particulate-usp788/acceptance-criteria/ · retrieved 30 July 2026