First prove that the certificate belongs to the material

Match product name, supplied form, lot number, manufacturing or release date, retest or expiry statement and the label on the received container. A polished generic sample COA is not evidence for the lot being purchased.

  • Product and supplied form
  • Lot or batch identifier
  • Release status and authorized sign-off
  • Dates and storage statement

Map every claim to a method

RP-HPLC can describe a relative peak profile under stated conditions. Mass spectrometry can support identity. Water, counter-ion, residual solvent, endotoxin and peptide content answer other questions. Ask which method supports each reported value.

  • HPLC method context and chromatogram
  • Observed versus theoretical mass
  • Assay or content basis
  • Water and counter-ion where material
  • Additional risk-based tests

Define acceptance before third-party testing

Agree the sampling method, laboratory, test method, specification, rounding rule, retest rule and commercial remedy before shipment. Otherwise two competent laboratories can produce results that are difficult to compare.

Primary references

ICH Q2(R2) Validation of Analytical Procedures