First, trace the sample.
Start with the compound identity, supplier, lot identifier, laboratory, report date and sample description. Compare the report’s lot number with the material you are evaluating. A match is a useful consistency check; it is not proof that the report is authentic or that the tested sample represents everything shipped.
Use the laboratory’s own report-verification service or contact details to confirm the document. A supplier’s copy and a laboratory’s original record may provide different levels of traceability.
Ask what was measured.
Analytical procedures are designed for particular purposes. ICH Q2(R2) treats identity, purity/impurities and assay as distinct analytical uses. The method and validation must fit the attribute being measured. Read the analytical-validation framework.
| Reported attribute | Question to ask | Do not assume |
|---|---|---|
| Identity | Which reference and method support the assigned identity? | A matching name on a label establishes identity. |
| HPLC area purity | How were peaks detected, assigned and integrated? | The percentage is the amount of peptide in a vial. |
| Content / assay | What quantity is reported, on which basis and with what uncertainty? | Area purity and mass content are interchangeable. |
| Other tests | Which specific attributes were tested, and against which specification? | Unlisted tests were performed or passed. |
Make the gaps explicit.
A report should be read within the scope of its actual tests. Unreported sterility, endotoxin, solvent or stability results remain unknown. A “high purity” headline does not answer those separate questions.
Likewise, a report does not by itself establish the product’s manufacturing origin, a universal shelf life, or suitability for a human application. Keep a list of questions that the document does not answer rather than filling those gaps with assumptions.
Sources & scope
- FDA: ICH Q2(R2), Validation of Analytical Procedures. Used for the distinction between analytical purposes and fit-for-purpose validation; it does not certify this tool or these suppliers.
- EMA: ICH Q2(R2) guideline and version history.