Intrabatch precision

Within-run, intrabatch precision or repeatability, which assesses precision during a single analytical run... 

Precision should be measured using a minimum of five determinations per concentration. A minimum of three concentrations in the range of expected concentrations is recommended. The precision determined at each concentration level should not exceed 15 % of the coefficient of variation (CV) except for the LLOQ, where it should not exceed 20 % of the CV. Precision is further subdivided into within-run, intrabatch precision or repeatability, which assesses precision during a single analytical run, and between-run, interbatch precision or reproducibility, which measures precision with time, and may involve different analysts, equipment, reagents, and laboratories. Since it is not always easy to obtain data about the reproducibility in the strict sense it often makes sense to use intermediate precision this expresses within-laboratories variations on different days, by different analysts, and on different equipment, etc. [60],... 

Internal standard. Selectivity, intrabatch precision and accuracy, recovery. 

During validation, the five QCs should be tested in a minimum of six runs, at least in duplicate. It is not acceptable to discard any runs during this testing. The inter- and intrabatch precision and accuracy from all runs performed should be reported. It is generally expected that the precision and accuracy acceptance be at least 20-25% of the target range with a Total Error not exceeding 30%. (Total Error acceptance criterion is discussed later in this report.)... 

Linearity, recovery, LOQ, intrabatch precision and accuracy, in-process solution stability. Additionally, if injection solvent is changed, processed sample stability should be checked, but recovery or in-process stabihty checks are not necessary. 

Linearity, LOQ (if reduced), lower end of the intrabatch precision and accuracy at revised upper or lower levels. 

Table 8.2. Intrabatch Accuracy (% RE) and Precision (% RSD) for Gemcitabine and Its Deaminated Metabolite11...

Repeatability (ICH) The precision of repeated measurement under the same operating conditions over a short interval of time (within one run), also termed intrabatch or intrarun precision. 

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