Intermediate precision- Intermediate precision expresses within-laboratory variations in results: different days, different analysts, different equipment, etc. This is to examine the effects of random events on the precision of an analytical method. Intermediate Precision therefore gives a first indication already of the future transferability of an analytical method.
Reproducibility- Reproducibility is the closeness of the agreement between the results of measurements of the same measure and carried out under changing conditions of measurements (e.g. operator, system, columns, etc.) or the ability of a test or experiment to be accurately reproduced, or replicated, by someone else working independently. Reproducibility is usually expresses as the precision between collaborative laboratories.
Range- The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity. Typical values for drug substance & drug product assay (80 to 120% of test concentration), for content uniformity assay (70 to 130% of test concentration) and for dissolution test methods (+/- 20% over entire specification range) are determined.
Detection Limit (DL)- The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value. Numerous methods are available to determine the DL.
Quantitation Limit (QL)- The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products.
System suitability- System suitability testing is an integral part of many analytical procedures. The tests are based on the concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such. System suitability test parameters to be established for a particular procedure depend on the type of procedure being validated.
Robustness- The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage. Some examples are: HPLC (mobile phase composition, different columns, temperature, and flow rate).
Ruggedness- can be defined there as the degree of reproducibility of the test results obtained under a variety of normal test conditions performed in different laboratories with different analysts, different instruments, different reagent lots, etc.).
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