Identity
Whether the source reports correspondence with the stated identity.
Peptide testing and documentation limits
A result answers only the question described by its sample, method and scope. Define does not infer unpublished results or transfer one record to another product or batch.
Direct answer: Identity, purity, sterility, endotoxin and measured content are separate statements. The absence of a report is not a test result.
Hypothetical example: a document names a sample and reports HPLC purity, but contains no identity result. That purity value cannot establish the sample’s identity or connect the record to a fulfilled batch.
What can a report establish?
Purity
A method-specific composition result; not proof of identity or sterility.
Measured content
A separately reported quantity that cannot be inferred from the label amount.
Other measures
Sterility and endotoxin each require their own source and result.
How is a report matched?
- Product
The code-safe product identity must match.
- Variant
Amount and format cannot be assumed.
- Identifiers
Report and sample identifiers must be visible when published.
- Limits
A library record does not automatically identify a supplied vial.
What is currently published?
No batch reports are currently published. The central CoA library remains non-indexable until an approved report with verified scope is available.
What are the limitations?
No. Missing or unpublished information remains neutral.
Only an explicit, verified mapping could establish that relationship. A library entry alone is insufficient.
Source framework
The general concepts of analytical-procedure suitability and validation are used only as an interpretation framework; they are not evidence that any Define product has been tested.
- EMA — ICH Q2(R2) validation of analytical procedures
- FDA — Analytical Procedures and Methods Validation
Structure last reviewed 22 September 2026. Product-specific evidence remains unpublished.