Educational scope: Laboratory documentation, analytical methods, and research recordkeeping only.
Fit for purpose
Validation is used to demonstrate that an analytical procedure is suitable for its intended purpose. The characteristics that matter depend on whether the method evaluates identity, purity, content, impurities, or another property.
Common performance characteristics
Specificity or selectivity, accuracy, precision, range, quantitation limit, detection limit, and robustness describe different aspects of procedure performance. Not every characteristic applies in the same way to every method.
Results need a procedure
A reported number becomes more useful when the procedure, validation status, system-suitability approach, and acceptance criteria are clear. Method context is part of the analytical evidence.
References and further reading
Research-use notice
This material is educational and does not provide medical, dosing, administration, or human-use guidance.
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