A Guide to Analytical Method Development: Part 2
The qualification phase assists in establishing early preliminary acceptance criteria.
Recommended qualification parameters:
- Specificity: Specific evaluation of a test component or reference sample while in the presence of other components.
- Accuracy: Closeness or exactness between an accepted true value and an accepted reference value.
- Linearity: Ability to obtain test results directly proportional to concentration/amount of analyte.
- Range: Interval between the UPPER and LOWER concentration/amount of analyte.
- Limit of Detection: Lowest concentration/amount in a test component that CAN BE DETECTED but NOT QUANTIFIED.
- Limit of a Quantitation: Lowest concentration/amount in a test component that CAN BE QUANTIFIED.
- Precision Repeatability: Precision under the same operating conditions over a short interval of time.
- Robustness: Measure of its capacity to remain unaffected by small but deliberate variations in method parameters.
Learn more about the Qualification phase of Analytical Development in the infographic below:
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