Editorial educational content. Specialist review is not claimed; consult the original references and limitations.
Definition and context
Determination of quantity or activity using a defined procedure.
What to check
Check standards, units and whether the result refers to a dry basis or the material as received.
Interpretation
Assay does not always mean chromatographic peak-area percentage.
Sources and verification scope
Q2(R2) Validation of Analytical Procedures ↗
FDA / ICH
Source details (original language)
- Scope
- Validation framework for analytical procedures
- Document section
- Final guidance summary
- Limitations
- Method validation does not certify this company or establish a result for a catalog lot.
- Claim verification date
- 2026-09-09
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