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8.4.7 ANALYTICAL METHODS The aim of validation of an analytical procedure is to demonstrate that the method employed in any product testing, such as the identi cation, control of impurities, assay, dissolution, particle size, water content, or residual solvents, is validated in the most important characteristics. Identi cation tests, quantitative tests for impurities content, limit tests for control of impurities, and quantitative tests of the active moiety in samples of pharmaceutical product are the most common types of analytical procedures that validation addresses [1]. However, other analytical procedures, such as dissolution testing for dosage form or particle size determination for drug substance, are required for validation of analytical procedures. The revalidation of an analytical procedure is possible when, in particular circumstances, it could show changes in the synthesis of the drug substance, the composition of the nished product, or the analytical procedure. However, certain other changes may require validation as well. Method validation should con rm that the analytical procedure employed for a speci c test is suitable for its intended use. The validation of an analytical method



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[14] Y Xuan, CM Snowden, A generalised approach to the design of microwave oscillators , IEEE Trans Microwave Theory Tech, 35(12), 1340 1347, 1987 [15] Y Xuan, CM Snowden, Optimal computer-aided design of monolothic microwave integrated oscillators , IEEE Trans Microwave Theory Tech, 37(9), 1481 1484, 1989 [16] Y Mitsui, M Nakatani, S Mitsui, Design of GaAs MESFET oscillator using large-signal S-parameters , IEEE Trans Microwave Theory Tech, 25(12), 981 984, 1977 [17] EW Bryerton, WA Shiroma, ZB Popovic, A 5-GHz high-ef ciency class-E oscillator , IEEE Microwave Guided Wave Lett, 6(12), 441 443, 1996 [18] M Prigent, M Camiade, G Pataut, D Reffet, JM Nebus, J Obregon, High ef ciency free running class-F oscillator , IEEE MTT-S Int Symp Dig, 1995, pp 1317 1320 [19] V Rizzoli, A Costanzo, A.





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Neri, Harmonic-balance analysis of microwave oscillators with automatic suppression of degenerate solution , Electron Lett, 28(3), 256 257, 1992 [20] CR Chang, MB Steer, S Martin, E Reese, Computer-aided analysis of free-running oscillators , IEEE Trans Microwave Theory Tech, 39(10), 1735 1745, 1991 [21] BD Bates, PJ Khan, Stability of multifrequency negative-resistance oscillators , IEEE Trans Microwave Theory Tech, MTT-32, 1310 1318, 1984 [22] V Rizzoli, A Costanzo, C Cecchetti, Numerical optimisation of microwave oscillators and VCOs , IEEE MTT-S Int Microwave Symp Dig, 1993, pp 629 632 [23] V Rizzoli, A Neri, Harmonic-balance analysis of multitone autonomous nonlinear microwave circuits , IEEE MTT-S Int Microwave Symp Dig, 1991, pp 107 110 [24] KKM Cheng, JKA Everard, A new and ef cient approach to the analysis and design of GaAs MESFET microwave oscillators , IEEE MTT-S Int.

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Microwave Symp Dig, 1990, pp 1283 1286 [25] LO Chua, YS Tang, Nonlinear oscillation via volterra series , IEEE Trans Circuits Syst, CAS-29(3), 150 167, 1982 [26] LO Chua, CY Ng, Frequency-domain analysis of nonlinear systems: formulation of transfer functions , Electron Circuits Syst, 3(6), 257 269, 1979 [27] Y Hu, JJ Obregon, J-C Mollier, Nonlinear analysis of microwave FET oscillators using volterra series , IEEE Trans Microwave Theory Tech, MTT-37(11), 1689 1693, 1989 [28] RG Rogers, Theory and design of low phase noise microwave oscillators , Proc 42nd Annual Frequency Control Symposium, 1988, pp 301 303 [29] J Verdier, O Llopis, R Plana, J Graffeuil, Analysis of noise up-conversion in microwave eld-effect transistor oscillators , Trans Microwave Theory Tech, 44(8), 1478 1483, 1996 [30] M Regis, O Llopis, J.

tion technology, it is shaped according to important design patterns and architectural principles that reduce complexity for the functional developer. The complexities largely hidden from the functional developer include both technical "plumbing" and distributed business system complexities . Figure 3 .1, a runtime view of two DCs, A and B, illustrates the essential elements of a DC from the functional developer's viewpoint . In the figure, DC A is invoking DC B by sending it a message . Physically, the message is handled by the component execution environment (CEE) ; however, the figure shows the logically direct invocation . The essential elements are as follows : Functional code . This is the code internal to the DC that the functional developer must write for the DC to provide the business function . Other parts of the DC can be generated or handled by generic code .

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