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Laboratory standards

Interpreting certificates of analysis

What belongs on a certificate, how to read one, and the conclusions it cannot support.

A certificate of analysis records the results of defined tests on a defined batch. A certificate that omits the method, the acceptance criterion, the batch identifier or the date has left out the information needed to interpret the numbers it contains.

What a complete certificate contains

  • Material identification, including any salt form and modifications.
  • Batch identifier, matching the physical container.
  • Each test performed, with the analytical method named.
  • The acceptance criterion for each test, alongside the result obtained.
  • The date of testing and the identity of the testing party.
  • A signature or equivalent authorisation, and a statement of whether the testing party is independent of the supplier.

Where a certificate is used to support a claim, the claim can be no stronger than the weakest link between the document and the material: the traceability of the batch identifier, the scope of the method, and the independence of the party that signed it.

References