Precision

Precision

Precision is the measurement of agreement among individual test results when an analytical method is used repeatedly for multiple samplings of a homogenous sample. Is it performed for drug substance and drug product at both the assay and related compound levels.

Repeatability is determined by analyzing a statistically significant number of aliquots from a homogenous sample (usually six individually prepared samples, each analyzed at 100% of the test concentration). This is reported as %RSD.

Intermediate precision is usually performed as part of ruggedness. Intermediate precision is repeatability performed by different analysts or on different days. This is also reported as %RSD.