Method Specificity Selectivity

The issue regarding the desired level of test method specificity selectivity is one that requires some case-by-case evaluation. In most instances, the key potential contaminant is considered to be the last active drug agent(s) that was in contact with the equipment surfaces. Typically, if it can be demonstrated that the active agent(s) has been removed to an acceptable residual level, and if the equipment is visibly cleaned, then the assumption is made that drug product excipients and other...

Precision and Accuracy

The definitions of precision and accuracy are presented in Chapter 2. The goal of this section is to describe all the steps necessary to achieve precision and accuracy appropriate for trace analysis in biofluids. The majority of analytical measurements are relative in nature, which means that results are obtained by comparing sample responses with those of authentic standards. Hence, the quest for accuracy begins with a reference standard 9 , The best reference standard for well-established and...

Ruggedness and robustness

There is a certain lack of uniformity and certainly a degree of confusion in the literature and in the various compendia and regulatory guidelines regarding the definitions of ruggedness and robustness 10, 35, 36, 39, 40 , Whereas in some circles the ruggedness and robustness are synonymous, the USP defines ruggedness 35 as the degree of reproducibility of test results obtained by the analysis of the same samples under a variety of normal test conditions, such as different laboratories,...

Y0bs y

Where n is the number of solutions used to prepare the standard curve and m is the number of measurements made on the test sample. Figure 2.7 shows that the confidence interval for a concentration determined from a linear, unweighted calibration curve is narrowest at the centroid x,y and increases on either side. In addition to allowing calculation of the confidence interval for a measured concentration, eq. 2.24 also allows the analyst to calculate the effect of increasing the number of repeat...

Apparatus

For a dissolution test to be used universally to control the consistency of a pharmaceutical dosage form, some controls must be placed on the type of apparatus used. The USP XVIII and NF XIV described only three types of apparatus 1 , but more recent developments in dissolution testing have resulted in seven types of apparatus approved for use in the USP 23 NF 18 7 , USP apparatus Type 1 and Type 2 are by far the most frequently used for immediate release and most sustained release dosage...