How to read a peptide certificate of analysis

How to read a peptide certificate of analysis: A careful reading of the evidence behind a batch.

Match the material

Check the compound name, form, batch identifier, and report date. The report and material should refer to the same lot. A generic certificate cannot establish the identity of a particular batch.

Separate identity from purity

Chromatography can describe purity under a stated method; mass spectrometry can support molecular identity. One percentage does not answer every quality question.

Look at the underlying report

Identify the laboratory independently. Examine the method and underlying chromatogram or spectrum where available. Reused, incomplete, or inconsistent documents warrant further questions.

Understand the limit

A certificate describes a tested sample at a particular time. Alone, it cannot demonstrate sterility, clinical safety, stability after transport, or the contents of every individual vial.

Sources & scope

FDA / ICH Q6A: analytical specifications

Quick glossary

mg / μg
1 mg = 1,000 μg. These are mass units.
mg/ml
Mass per volume; not the total mass in a vial.
COA
Certificate of analysis: check the exact lot, method and scope.
Preclinical
Cell or animal research does not establish a human treatment outcome.
Identity
Product name and strength.
Lot
Match the vial to the report.
Method
Check the test method.
Date
Check the analysis date.
Scope
Read what was tested.

For in-vitro laboratory research only. Not for human or veterinary use.