Purpose: This page explains how to assess analytical reports and certificates of analysis (CoAs). Elite Peps Australia is an independent knowledge publication and does not sell products or issue batch certificates.
What a defensible report should identify
- The laboratory, report number, issue date and authorised signatory.
- A traceable sample identifier, receipt condition and chain-of-custody context.
- The analytical method, instrument, reference standard and acceptance criteria.
- Results with units, uncertainty or method limitations where relevant.
- Chromatograms, spectra or other raw-data summaries sufficient to interpret the conclusion.
Purity and identity answer different questions
An HPLC area percentage describes the relative detector response of resolved peaks under a specific method. It is not automatically mass purity, does not identify every impurity and does not by itself prove molecular identity. Mass spectrometry can support identity by comparing observed and expected mass-to-charge signals, but it does not by itself establish purity, sterility, endotoxin status or suitability for human use.
Questions to ask
- Was the method validated or verified for this analyte and matrix?
- Was an appropriate reference standard used?
- Are specificity, linearity, range, accuracy, precision and detection limits addressed?
- Does the report distinguish tested facts from interpretation?
- Can the laboratory’s accreditation scope be checked independently?
See our field guide to reading a peptide laboratory report, Australian laboratory verification guide and the ICH Q2(R2) guideline. Australian accreditation scopes can be checked through NATA.
Scientific information only. A report should never be used as a substitute for regulatory approval or clinical evidence.