By Stanley Nusim

ISBN-10: 082470293X

ISBN-13: 9780824702939

This consultant bargains present and well timed discussions of the method improvement cycle, layout engineering, the approval approach, qc and coverage, and validation, in addition to plant production actions together with fabrics administration, upkeep, and safeguard.

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Extra info for Active Pharmaceutical Ingredients. Development, Manufacturing, and Regulation

Sample text

A. Bench development of the route (or routes) of choice is pursued aggressively, ideally by both synthesis chemists and chemical engineers, with the former elucidating reaction pathways and byproducts, seeking superior reaction conditions (solvents, catalysts, auxiliary chemicals, temperature, pressure, concentrations, reactant ratios, and approximate kinetics) as well as probing work-up and isolation methods. ). Such bench development by both disciplines is what transforms a synthesis route into a process candidate for scale-up and eventual manufacture.

Figure 7 depicts this preparative environment, whereas Figure 7 The resources for the preparative task. The need to engage larger-scale resources depends on the scope of the preparative task, which can vary widely (Table 1 and Fig. 8). Process Development 27 Figure 8 The scope of the preparative task. Some examples to illustrate the dependence of the preparative effort on drug potency, therapeutic target, and scope of the clinical effort. Fig. 8 complements the range of preparative scopes presented in Table 1.

Once chirality is obtained, the route preserved it. 5. Minimal need for blocking=deblocking. 6. Absence of highly hazardous materials, reactions, or intermediates. 7. , green chemistry). 40 Rosas 8. Probable cost is appropriate to the product. 9. Fits nicely with existing plant running a related process. The relative priorities of these factors vary widely, as they are seldom all present; neither are they fully independent from each other. For example, directness of synthesis may come at the price of a very expensive reactant, or would require that a very hazardous intermediate be made and perhaps isolated.

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Active Pharmaceutical Ingredients. Development, Manufacturing, and Regulation by Stanley Nusim

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