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For the impurity test, the determination should be established by spiking drug substance or drug product with the appropriate levels of impurities and demonstrating the separation of these impurities individually and/or from other components in the sample matrix Representative chromatograms should be used 2 If Impurities Are Not Available Speci city may be demonstrated by comparing the test results of samples containing impurities or degradation products to a second well-characterized procedure or other validated analytical procedure (orthogonal method) This should include samples stored under relevant stress conditions (light, heat, humidity, acid/base hydrolysis and oxidation) For the assay method, the two results should be compared; for impurity tests, the impurity pro les should be compared Peak homogeneity tests should be performed using PDA or mass spectrometry to show that the analyte chromatographic peak is not attributable to more than one component.

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chain At the service side, we can have a similar situation; we then often speak of a multi-mode server General QBD models are very important in studying the performance aspects of communication systems subject to complex arrival streams and to systems with server breakdowns and repairs However, their specification at the level of the block matrices constituting the Markov chain is cumbersome Instead, one should use higher-level mechanisms to construct these models; we will see an example of such an approach in 17 In the QBD models we have addressed in this chapter the state space has been unbounded in one direction In other words, we have addressed system models with an infinite buffer QBD models on a finite state space can be studied with similar means.

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The reason for the effectiveness of this technique is given in the Von Karmen Institute lecture notes (9). 8.1.2.2 Grid For the model of the precalciner, a block structured body fitted grid was developed. The outside surface of the grid is illustrated in Fig. 8.1. One coal inlet is not visible, but it is located directly opposite the coal inlet that is visible on the conical section. It can be seen that the grid in the region of the coal inlet has been refined. The grid refinement was done by the hanging-node method, which divides each hexahedral cell in to eight new hexahedral cells. The cells were refined in the region encompassed by three concentric spheres with coincident centres at the centre of the coal inlet. Thus, three refinement regions can be seen on the

vol a tile4 adjective 1: readily vaporizable at a relatively low temperature 2: flying or having the power to fly 3: a: lighthearted b: easily aroused <volatile suspicions> c: tending to erupt into violence 4: a: unable to hold the attention fixed because of an inherent lightness or fickleness of disposition b: characterized by or subject to rapid or unexpected change 5: difficult to capture or hold permanently non vol a tile5 1: not volatile: a: not vaporizing readily b: of a computer memory : retaining data when power is shut off

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For the MIPHIl and the PHlMll queue, the matrix R that needs to be computed is in fact the same as the one that is computed in the unbounded case; the only difference lies in another normalisation equation For general QBDs on a finite state space, we have to deal with two different boundaries of the state space (one corresponding to the empty system and one corresponding to the completely filled system) This most naturally leads to two second-order matrix equations that need to be solved, as well as two sets of boundary equations The state probabilities gi can then be computed as the sum of two geometric terms A remark should be made here about another powerful solution method for queueing models with a QBD structure known as the spectral expansion method.

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