For lawful in-vitro, analytical and laboratory research use only. Not intended for human or veterinary use, consumption, diagnosis, treatment or disease prevention.

Analytical science

How to read a Certificate of Analysis

A framework for checking sample identity, scope, methods and results in an analytical report.

A framework for checking sample identity, scope, methods and results in an analytical report.

Document and sample identification

A useful CoA clearly connects the document to the material tested. Check the name, unique identifier, dates, laboratory and approval status. If these do not allow reliable matching, even a detailed result has limited traceability.

Method, specification and result

Each test should state what was measured, by which procedure and against what criterion. A result without a unit or clear calculation basis can be misread. The word “passes” is meaningful only when the corresponding specification is visible and suitable.

What a CoA does not prove

A CoA summarises defined tests on a particular sample. It does not establish every possible attribute or replace evaluation of the method and laboratory. Confidence is strengthened when primary data or a report is available on request.

Sources and further reading

  1. ICH Q2(R2) — Validation of Analytical Procedures
  2. EMA / ICH Q14 — Analytical procedure development
RESEARCH-USE BOUNDARY

For lawful in-vitro, analytical and laboratory research use only. Not intended for human or veterinary use, consumption, diagnosis, treatment or disease prevention.

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