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Active Pharmaceutical Ingredients. Development, by Stanley Nusim PDF

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 method, qc and insurance, and validation, in addition to plant production actions together with fabrics administration, upkeep, and safeguard.

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Additional resources for Active Pharmaceutical Ingredients. Development, Manufacturing, and Regulation

Example text

Applied effort plane (Fig. 6), the development stage comprises the most productive development effort: (a) Synthesis work at the bench scale seeks the eventual manufacturing route in earnest, preferably on more than one approach, with all promising a substantial, if not overwhelming, advantage over the current preparative procedures. In chemical synthesis, the route is basically driven by the structure of the target compound. Within that logic, however, the creativity of the process chemist is bounded only by the realities of starting materials availability.

Thus, the importance of providing the required material on time to get those answers as soon as possible. This reflects on the need for capital investment in facilities such as kilo lab or pilot plant, and we will discuss elsewhere in this chapter the challenges of this stage of development when the preparative stage depends on outsourcing (the reliance on outside suppliers). Indeed, sufficient internal resources for the preparative stage is a clear competitive advantage, with the optimal setting providing the means—hardware and engineering skills—to swiftly overlap the kilo lab work with pilot plant work-up to, say, 1000 L vessels and the appropriate auxiliaries and operating environment (safety, industrial hygiene, and pollution abatement).

Accordingly, an effort will be made to define such terms at the point of first use, as well as to use them sparsely. For example, unit operations are those methods that can be found repeatedly used in chemical processing and that have a common phenomena root, their many variations notwithstanding—filtration to separate solids from an accompanying liquid, distillation to separate volatile components from a mixture, or milling to reduce the particle size of particulate solids. The organization of chemical processing on the basis of such unit operations was crucial to the development of organic chemical technology, which was 18 Rosas originally arranged on the chemistry basis of unit processes, such as nitration, sulfonation, or esterification.

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


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