All the vials in a batch share an origin: the same synthesis, the same purification and the same freeze-drying. That is why a representative sample of the batch is analysed and the result applies to all of its vials. The batch number printed on the label is the thread that ties a specific vial to its certificate of analysis.
Traceability is the ability to reconstruct that path: which batch a vial comes from, which analyses it has, when it was made and under what conditions it has been stored. If a problem appears, it makes it possible to identify which other vials share the same origin.
In practice, a useful traceability system lets anyone look up a batch number and see the matching certificate, instead of relying on generic documents sent on request.
Without a batch number, a certificate of analysis cannot be linked to any vial, and the declared purity is no longer verifiable. It is the piece that makes the rest of quality control meaningful.
Related terms
Learn it in depth at the Peptide University
- Peptide content, water, counterion and reading the COA · Module 7
- Classification and solid-phase synthesis · Module 1
- Related impurities and counterions · Module 7
- Pharmacovigilance, quality and evidence-based practice · Module 10
- HPLC: the measure of purity · Module 7
Definition for educational and scientific purposes. It is not medical advice or a recommendation for use. NeoPeptidos products are sold labelled for research use only (RUO).