Methodological standard · §5
CEI-MS-20 — 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 |
|---|---|---|
| Visible illumination delivered | ≥ 1.2 million lux hours, measured | Adequate challenge |
| Near-ultraviolet energy delivered | ≥ 200 W·h/m², measured | Adequate challenge |
| Dark-control degradation | Recorded and subtracted | Separation of thermal from photolytic routes |
| Method suitability for photolytic degradants | Demonstrated under CEI-MS-13 | Detection capability |
§5.2Acceptance criteria
- A compound is designated light-sensitive where photolytic degradation in a transparent container exceeds the dark control by a margin the method can distinguish.
- A light-sensitive compound requires an opaque or amber container and a light-protection statement on the certificate. The Institute has not assessed a research-supply certificate that carries one.
§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.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q1A(R2) Stability Testing of New Drug Substances and Products. ICH Harmonised Tripartite Guideline 2003;Step 4 version. 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-20/5 · https://compoundevidence.com/methods/photostability/acceptance-criteria/ · retrieved 30 July 2026