Editorial educational content. Specialist review is not claimed; consult the original references and limitations.
Definition and context
A proportion defined by an analytical approach and calculation basis.
What to check
For a reported percentage, request the method, detector response and integration basis. Other impurities may need separate tests.
Interpretation
Purity, assay and sterility are different attributes.
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
Related reading
Assay
Determination of quantity or activity using a defined procedure.
Read details →Peptide content
The amount attributed to the peptide on a defined analytical basis.
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