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Number system limit comparison test

Reference items can be one or more items where a specific readout and well-known responses are expected. The reference item(s) is used to provide a basis for comparison with the test item or to compare the response of the test system to the test item. Reference items should be specific to the endpoint being measure, i.e., provide a known measurable or observable response. Reference item(s) should be tested for batch to batch variability and be appropriately characterized (e.g., purity, stability) and identified (e.g., CAS number). Solubility, stability, and purity need to be established for each reference item used, and acceptance criteria based on historical data developed. The continuous monitoring of the reference items is important to prove that the in vitro method continues to perform within the limits and consistent over time. [Pg.559]

The model for ionic retention and ion-pair chromatography that are discussed in Sections 15.2 and 15.3 has been tested and applied to a number of different systems and works very well in most of the cases. From colloid and surface chemistry is known that the model has its limitations, and under certain chromatographic conditions, the presented model will not be valid. The limitations of the model when applied to reversed-phase chromatography of ions still need to be found. Some are self-evident, such as if the pairing-ion concentration is close or above the CMC or when the retention factor is very low so that the accumulation in the double layer is important in comparison to the adsorption, see Ref. [7] for a discussion concerning the accumulation in the double layer. [Pg.432]

When evaluating the influence of the time of year on responses of aquatic communities to chemical stress, it is convenient to make a distinction in threshold concentrations of direct toxic effects, and in the magnitude of effects that occur above these threshold concentrations. Only a limited number of (model) ecosystem experiments are available that allow a comparison of responses due to treatment with the same chemical in the same type of test system at different periods of the year. These studies indicate that, in freshwater communities, threshold concentrations for direct toxic effects may vary little with the season (within a factor of 2). At higher exposure concentrations, however, the intensity and duration of the responses (direct and indirect effects) may vary considerably between different periods of the year (Section 6.3.2). [Pg.220]

The first sample in line along the wall should see a Reynolds number of about 2.7 x 10 the last one, about 3.2 x 10. At the last station, Cf should be about 0.0056, and thus the deposition velocity should be 0.63 cm/sec. The earlier stations should have higher values. Edney et al. report a measured value of 0.9 cm/sec (14). This higher value could either be a result of increased turbulence in this particular flow system or the effects of lower Reynolds numbers at the more upstream test positions. In any event, this comparison indicates that, under these conditions, the flux of SO2 to the surface appears to be controlled by the atmospheric resistance, and is apparently not limited by uptake on the surface. [Pg.420]

A sampling plan for attributes is a method to overcome this problem. An example of such a plan is the Accepted Quality Level system (AQL) (See Sect. 24.5.4. for a more complete description of AQL and Sect. 20.4.5 for a statistic background). In order for the AQL system to be successful an extensive and statistically planned random sample has to be selected. The defects that are found are classified into levels, for example critical, major, minor. Within each level the system defines an acceptable quality level . When a quality level is exceeded, then a batch should be rejected. This method of testing requires time and expertise. Sampling has to be performed from a large number of containers from the same batch. Within the pharmaceutical industry it is often necessary for such tests to be carried out by the container manufacturer. For smaller enterprises such as pharmacies quality control can be undertaken by the wholesaler or an independent laboratory. Within a (hospital) pharmacy the quality control is often limited to a visual comparison to reference samples and a check of the presence of the supplier s statement that the containers comply with the agreed specifications [46]. [Pg.533]


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