Interpreting certificates of analysis

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.