Methodological standard · §5
CEI-MS-09 — 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 |
|---|---|---|
| Illumination at the inspection point | 2000–3750 lux | Detection sensitivity |
| Observer qualification | Documented visual acuity assessment | Inspection reliability |
| Diluent blank | Free of visible particulate | Diluent suitability |
§5.2Acceptance criteria
- A collapsed cake, a colour inconsistent with the compound, visible particulate in the reconstituted solution, or a reconstitution time exceeding the stated limit is recorded as a finding and reported.
- This determination is never sufficient on its own, and is never omitted: it is the only assessment in the series that requires no instrument and it detects failures that instrumental methods can miss.
§5.3Limitations
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- United States Pharmacopeial Convention. General Chapter ⟨788⟩ Particulate Matter in Injections. United States Pharmacopeia — National Formulary (USP–NF) 2024;USP 2024 Issue 1. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-MS-09/5 · https://compoundevidence.com/methods/appearance-solubility/acceptance-criteria/ · retrieved 30 July 2026