Supporting AMV Method Performance Characteristics for HPSEC (Ideally pre-AMV)
| Analytical Method Performance Characteristic | Retrospective (AMD/AMQ) or Prospective Evaluation During AMV Studies |
|---|---|
| Robustness | Deliberately perform minor changes to critical assay parameters such as incubation temperature or time. Use design-of-experiment (DOE) matrix. |
| Signal Response Factors | Establish analyte response factors whenever multiple components are present. |
| Degradation (for Stability-Indicating Methods) | Establish stability profile and degradation pathways of samples, impurities, and by-products. |
| Stability of All Material | Evaluate the short-term (during testing) and long-term (during storage) stability of samples, controls, reagents, and material. |
| System Suitability | Establish that components of the test system are suitable for routine testing. |
| Sample Suitability | Establish that sample and/or testing replicates are appropriate to routinely support accurate and reliable test results. |
| Significant Digits (or Rounding Unit(s)) | Establish the maximum number of significant digits (rounding unit(s)) in reported results from Repeatability (n = 6). Align with relevant specifications. |
Note: AMD, analytical method development; AMQ, analytical method qualification; AMV, analytical method validation; HPSEC, high-performance size-exclusion chromatography.