A certificate of analysis is a record of measurement, not a marketing claim. It should name the batch, the date of manufacture, the analytical methods used, the acceptance criteria applied and the result obtained against each one.
Identity answers a single question: is the material the molecule it claims to be? Mass spectrometry compares the measured molecular mass against the theoretical mass of the sequence. Purity is a separate question, usually resolved by reversed-phase HPLC and reported as a percentage of total peak area.
Water content, acetate content, peptide content and residual solvents are frequently omitted from thin certificates. Their absence is not evidence of their absence in the vial. Published pharmacopoeial chapters set out the expected form of these tests, and ICH Q2 defines what it means for the method itself to have been validated.
Research Status
An established analytical and regulatory standard, not an open scientific question -- the guidance below defines current practice rather than reporting a study result.
Selected Research
- ICH. ICH Q2(R2) — Validation of Analytical Procedures. International Council for Harmonisation, 2023.
- USP. General Chapters and Reference Standards. United States Pharmacopeia, 2024.
- FDA. Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only. U.S. Food and Drug Administration guidance, 2013.
Related Research